StemCell Therapy

Nanotechnology, the manipulation of matter at the atomic and molecular scale to create materials with remarkably varied and new properties, is a rapidly expanding area of research with huge potential in many sectors, ranging from healthcare to construction and electronics. In medicine, it promises to revolutionize drug delivery, gene therapy, diagnostics, and many areas of research, development and clinical application.

This article does not attempt to cover the whole field, but offers, by means of some examples, a few insights into how nanotechnology has the potential to change medicine, both in the research lab and clinically, while touching on some of the challenges and concerns that it raises.

The prefix nano stems from the ancient Greek for dwarf. In science it means one billionth (10 to the minus 9) of something, thus a nanometer (nm) is is one billionth of a meter, or 0.000000001 meters. A nanometer is about three to five atoms wide, or some 40,000 times smaller than the thickness of human hair. A virus is typically 100 nm in size.

The ability to manipulate structures and properties at the nanoscale in medicine is like having a sub-microscopic lab bench on which you can handle cell components, viruses or pieces of DNA, using a range of tiny tools, robots and tubes.

Therapies that involve the manipulation of individual genes, or the molecular pathways that influence their expression, are increasingly being investigated as an option for treating diseases. One highly sought goal in this field is the ability to tailor treatments according to the genetic make-up of individual patients.

This creates a need for tools that help scientists experiment and develop such treatments.

Imagine, for example, being able to stretch out a section of DNA like a strand of spaghetti, so you can examine or operate on it, or building nanorobots that can walk and carry out repairs inside cell components. Nanotechnology is bringing that scientific dream closer to reality.

For instance, scientists at the Australian National University have managed to attach coated latex beads to the ends of modified DNA, and then using an optical trap comprising a focused beam of light to hold the beads in place, they have stretched out the DNA strand in order to study the interactions of specific binding proteins.

Meanwhile chemists at New York University (NYU) have created a nanoscale robot from DNA fragments that walks on two legs just 10 nm long. In a 2004 paper published in the journal Nano Letters, they describe how their nanowalker, with the help of psoralen molecules attached to the ends of its feet, takes its first baby steps: two forward and two back.

One of the researchers, Ned Seeman, said he envisages it will be possible to create a molecule-scale production line, where you move a molecule along till the right location is reached, and a nanobot does a bit chemisty on it, rather like spot-welding on a car assembly line. Seemans lab at NYU is also looking to use DNA nanotechnology to make a biochip computer, and to find out how biological molecules crystallize, an area that is currently fraught with challenges.

The work that Seeman and colleagues are doing is a good example of biomimetics, where with nanotechnology they can imitate some of the biological processes in nature, such as the behavior of DNA, to engineer new methods and perhaps even improve them.

DNA-based nanobots are also being created to target cancer cells. For instance, researchers at Harvard Medical School in the US reported recently in Science how they made an origami nanorobot out of DNA to transport a molecular payload. The barrel-shaped nanobot can carry molecules containing instructions that make cells behave in a particular way. In their study, the team successfully demonstrates how it delivered molecules that trigger cell suicide in leukemia and lymphoma cells.

Nanobots made from other materials are also in development. For instance, gold is the material scientists at Northwestern University use to make nanostars, simple, specialized, star-shaped nanoparticles that can href=http://www.medicalnewstoday.com/articles/243856.php>deliver drugs directly to the nuclei of cancer cells. In a recent paper in the journal ACS Nano, they describe how drug-loaded nanostars behave like tiny hitchhikers, that after being attracted to an over-expressed protein on the surface of human cervical and ovarian cancer cells, deposit their payload right into the nuclei of those cells.

The researchers found giving their nanobot the shape of a star helped to overcome one of the challenges of using nanoparticles to deliver drugs: how to release the drugs precisely. They say the shape helps to concentrate the light pulses used to release the drugs precisely at the points of the star.

Scientists are discovering that protein-based drugs are very useful because they can be programmed to deliver specific signals to cells. But the problem with conventional delivery of such drugs is that the body breaks most of them down before they reach their destination.

But what if it were possible to produce such drugs in situ, right at the target site? Well, in a recent issue of Nano Letters, researchers at Massachusetts Institute of Technology (MIT) in the US show how it may be possible to do just that. In their proof of principle study, they demonstrate the feasibility of self-assembling nanofactories that make protein compounds, on demand, at target sites. So far they have tested the idea in mice, by creating nanoparticles programmed to produce either green fluorescent protein (GFP) or luciferase exposed to UV light.

The MIT team came up with the idea while trying to find a way to attack metastatic tumors, those that grow from cancer cells that have migrated from the original site to other parts of the body. Over 90% of cancer deaths are due to metastatic cancer. They are now working on nanoparticles that can synthesize potential cancer drugs, and also on other ways to switch them on.

Nanofibers are fibers with diameters of less than 1,000 nm. Medical applications include special materials for wound dressings and surgical textiles, materials used in implants, tissue engineering and artificial organ components.

Nanofibers made of carbon also hold promise for medical imaging and precise scientific measurement tools. But there are huge challenges to overcome, one of the main ones being how to make them consistently of the correct size. Historically, this has been costly and time-consuming.

But last year, researchers from North Carolina State University, revealed how they had developed a new method for making carbon nanofibers of specific sizes. Writing in ACS Applied Materials & Interfaces in March 2011, they describe how they managed to grow carbon nanofibers uniform in diameter, by using nickel nanoparticles coated with a shell made of ligands, small organic molecules with functional parts that bond directly to metals.

Nickel nanoparticles are particularly interesting because at high temperatures they help grow carbon nanofibers. The researchers also found there was another benefit in using these nanoparticles, they could define where the nanofibers grew and by correct placement of the nanoparticles they could grow the nanofibers in a desired specific pattern: an important feature for useful nanoscale materials.

Lead is another substance that is finding use as a nanofiber, so much so that neurosurgeon-to-be Matthew MacEwan, who is studying at Washington University School of Medicine in St. Louis, started his own nanomedicine company aimed at revolutionizing the surgical mesh that is used in operating theatres worldwide.

The lead product is a synthetic polymer comprising individual strands of nanofibers, and was developed to repair brain and spinal cord injuries, but MacEwan thinks it could also be used to mend hernias, fistulas and other injuries.

Currently, the surgical meshes used to repair the protective membrane that covers the brain and spinal cord are made of thick and stiff material, which is difficult to work with. The lead nanofiber mesh is thinner, more flexible and more likely to integrate with the bodys own tissues, says MacEwan. Every thread of the nanofiber mesh is thousands of times smaller than the diameter of a single cell. The idea is to use the nanofiber material not only to make operations easier for surgeons to carry out, but also so there are fewer post-op complications for patients, because it breaks down naturally over time.

Researchers at the Polytechnic Institute of New York University (NYU-Poly) have recently demonstrated a new way to make nanofibers out of proteins. Writing recently in the journal Advanced Functional Materials, the researchers say they came across their finding almost by chance: they were studying certain cylinder-shaped proteins derived from cartilage, when they noticed that in high concentrations, some of the proteins spontaneously came together and self-assembled into nanofibers.

They carried out further experiments, such as adding metal-recognizing amino acids and different metals, and found they could control fiber formation, alter its shape, and how it bound to small molecules. For instance, adding nickel transformed the fibers into clumped mats, which could be used to trigger the release of an attached drug molecule.

The researchers hope this new method will greatly improve the delivery of drugs to treat cancer, heart disorders and Alzheimers disease. They can also see applications in regeneration of human tissue, bone and cartilage, and even as a way to develop tinier and more powerful microprocessors for use in computers and consumer electronics.

Recent years have seen an explosion in the number of studies showing the variety of medical applications of nanotechnology and nanomaterials. In this article we have glimpsed just a small cross-section of this vast field. However, across the range, there exist considerable challenges, the greatest of which appear to be how to scale up production of materials and tools, and how to bring down costs and timescales.

But another challenge is how to quickly secure public confidence that this rapidly expanding technology is safe. And so far, it is not clear whether that is being done.

There are those who suggest concerns about nanotechnology may be over-exaggerated. They point to the fact that just because a material is nanosized, it does not mean it is dangerous, indeed nanoparticles have been around since the Earth was born, occurring naturally in volcanic ash and sea-spray, for example. As byproducts of human activity, they have been present since the Stone Age, in smoke and soot.

Of attempts to investigate the safety of nanomaterials, the National Cancer Institute in the US says there are so many nanoparticles naturally present in the environment that they are often at order-of-magnitude higher levels than the engineered particles being evaluated. In many respects, they point out, most engineered nanoparticles are far less toxic than household cleaning products, insecticides used on family pets, and over-the-counter dandruff remedies, and that for instance, in their use as carriers of chemotherapeutics in cancer treatment, they are much less toxic than the drugs they carry.

It is perhaps more in the food sector that we have seen some of the greatest expansion of nanomaterials on a commercial level. Although the number of foods that contain nanomaterials is still small, it appears set to change over the next few years as the technology develops. Nanomaterials are already used to lower levels of fat and sugar without altering taste, or to improve packaging to keep food fresher for longer, or to tell consumers if the food is spoiled. They are also being used to increase the bioavailablity of nutrients (for instance in food supplements).

But, there are also concerned parties, who highlight that while the pace of research quickens, and the market for nanomaterials expands, it appears not enough is being done to discover their toxicological consequences.

This was the view of a science and technology committee of the House of Lords of the British Parliament, who in a recent report on nanotechnology and food, raise several concerns about nanomaterials and human health, particularly the risk posed by ingested nanomaterials.

For instance, one area that concerns the committee is the size and exceptional mobility of nanoparticles: they are small enough, if ingested, to penetrate cell membranes of the lining of the gut, with the potential to access the brain and other parts of the body, and even inside the nuclei of cells.

Another is the solubility and persistence of nanomaterials. What happens, for instance, to insoluble nanoparticles? If they cant be broken down and digested or degraded, is there a danger they will accumulate and damage organs? Nanomaterials comprising inorganic metal oxides and metals are thought to be the ones most likely to pose a risk in this area.

Also, because of their high surface area to mass ratio, nanoparticles are highly reactive, and may for instance, trigger as yet unknown chemical reactions, or by bonding with toxins, allow them to enter cells that they would otherwise have no access to.

For instance, with their large surface area, reactivity and electrical charge, nanomaterials create the conditions for what is described as particle aggregation due to physical forces and particle agglomoration due to chemical forces, so that individual nanoparticles come together to form larger ones. This may lead not only to dramatically larger particles, for instance in the gut and inside cells, but could also result in disaggregation of clumps of nanoparticles, which could radically alter their physicochemical properties and chemical reactivity.

Such reversible phenomena add to the difficulty in understanding the behaviour and toxicology of nanomaterials, says the committee, whose overall conclusion is that neither Government nor the Research Councils are giving enough priority to researching the safety of nanotechnology, especially considering the timescale within which products containing nanomaterials may be developed.

They recommend much more research is needed to ensure that regulatory agencies can effectively assess the safety of products before they are allowed onto the market.

It would appear, therefore, whether actual or perceived, the potential risk that nanotechnology poses to human health must be investigated, and be seen to be investigated. Most nanomaterials, as the NCI suggests, will likely prove to be harmless.

But when a technology advances rapidly, knowledge and communication about its safety needs to keep pace in order for it to benefit, especially if it is also to secure public confidence. We only have to look at what happened, and to some extent is still happening, with genetically modified food to see how that can go badly wrong.

Written by Catharine Paddock PhD

Excerpt from:
Nanotechnology In Medicine: Huge Potential, But What Are ...

Verseons groundbreaking drug discovery platform was featured in Nano Magazines article on whether AI can fundamentally change drug discovery.

Fremont, United States December 21, 2021

Fremont, CA Verseons groundbreaking drug discovery platform was featured in Nano Magazines article on whether AI can fundamentally change drug discovery.

Nano Magazine concluded that although Verseon has built and used its own AI tools for parts of its drug development long before AI was a trendy buzzword, it has avoided the AI hype-fest. With its unique approach that combines physics-based molecular modeling and AI, Verseons platform changes how completely new drugs can be discovered. Whereas other players in AI-driven pharmaceutical development can only find small variations on existing compounds, Verseons platform drives pharmaceutical innovation with rapid, systematic development of multiple previously unexplored, chemically diverse candidates for each of its drug programs, which Nano Magazine called a feat unheard of in the pharmaceutical industry.

Pfizers former SVP of R&D Strategy and Verseon advisor Robert Karr said, Everyone else has merely dabbled in the field of systematic drug discovery. Verseons disruptive platform changes how drugs can be discovered and developed, and the company is poised to make a dramatic impact on modern medicine.

Verseon currently has 14 drug candidates spanning 7 programs in the areas of cardiovascular disease, diabetes, cancer, and liver disease in various stages of development and clinical testing.

Verseons anticoagulant program is currently in Phase 1 clinical trials. This drug (VE-1902) promises to change the standard of care for tens of millions of patients at risk for stroke and heart attack. Ideal treatment for these patients would be long-term combination therapy with antiplatelet and anticoagulant drugs, but this treatment protocol poses significant risk of major bleeding events. Verseons Precision Oral Anticoagulants (PROACs) promise to significantly reduce the risk of major bleeding and would make long-term combination therapy a safe and viable treatment.

UCL Professor of Cardiology John Deanfield remarked: Verseons platelet-sparing anticoagulants with their unique mode of action and low bleeding risk look very promising. Their drugs represent an exciting precision medicine opportunity for the treatment of a large population of cardiovascular disease patients.

About Verseon

To advance global health, Verseon International Corporation (www.verseon.com) has created a better, more scalable process for designing and developing new drugs addressing currently untreatable or poorly treated conditions. The companys drug development platform incorporates fundamental advancements in molecular modeling, directed synthesis, integrated translational research and advanced AI to develop drug compounds that have never before been synthesizedand are virtually impossible to find using conventional methods. Verseon is a clinical-stage company with a growing pipeline that currently includes seven drug programs in the areas of anticoagulation, diabetic retinopathy, hereditary angioedema, oncology, and metabolic disorders.

Contact Info:Name: Walter JonesEmail: Send EmailOrganization: VerseonAddress: 47000 Warm Springs Boulevard, Fremont, CA 94539, United StatesWebsite: https://www.verseon.com

Release ID: 89057403

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Verseon Praised for Disruptive Approach to Physics- and AI-Based Drug Discovery - Digital Journal

Endocr Rev. 2009 May; 30(3): 204213.

Program in Medical Ethics, the Division of General Internal Medicine, and the Department of Medicine, University of California San Francisco, San Francisco, California 94143

Received 2008 Jul 10; Accepted 2009 Mar 10.

[RPHR Note]

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Stem cell research offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinsons disease, and myocardial infarction. However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes about the onset of human personhood. The reprogramming of somatic cells to produce induced pluripotent stem cells avoids the ethical problems specific to embryonic stem cell research. In any hSC research, however, difficult dilemmas arise regarding sensitive downstream research, consent to donate materials for hSC research, early clinical trials of hSC therapies, and oversight of hSC research. These ethical and policy issues need to be discussed along with scientific challenges to ensure that stem cell research is carried out in an ethically appropriate manner. This article provides a critical analysis of these issues and how they are addressed in current policies.

I. Introduction

II. Multipotent Stem Cells

III. Embryonic Stem Cell Research

A. Existing embryonic stem cell lines

B. New embryonic stem cell lines from frozen embryos

C. Ethical concerns about oocyte donation for research

IV. Somatic Cell Nuclear Transfer (SCNT)

V. Fetal Stem Cells

VI. Induced Pluripotent Stem Cells (iPS Cells)

VII. Stem Cell Clinical Trials

VIII. Institutional Oversight of Stem Cell Research

STEM CELL RESEARCH offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinsons disease, and myocardial infarction (1). Pluripotent stem cells perpetuate themselves in culture and can differentiate into all types of specialized cells. Scientists plan to differentiate pluripotent cells into specialized cells that could be used for transplantation.

However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes regarding the onset of human personhood and human reproduction. Several other methods of deriving stem cells raise fewer ethical concerns. The reprogramming of somatic cells to produce induced pluripotent stem cells (iPS cells) avoids the ethical problems specific to embryonic stem cells. With any hSC research, however, there are difficult dilemmas, including consent to donate materials for hSC research, early clinical trials of hSC therapies, and oversight of hSC research (2). Table 1 summarizes the ethical issues that arise at different phases of stem cell research.

Ethical issues at different phases of stem cell research

Adult stem cells and cord blood stem cells do not raise special ethical concerns and are widely used in research and clinical care. However, these cells cannot be expanded in vitro and have not been definitively shown to be pluripotent.

Hematopoietic stem cells from cord blood can be banked and are widely used for allogenic and autologous stem cell transplantation in pediatric hematological diseases as an alternative to bone marrow transplantation.

Adult stem cells occur in many tissues and can differentiate into specialized cells in their tissue of origin and also transdifferentiate into specialized cells characteristic of other tissues. For example, hematopoietic stem cells can differentiate into all three blood cell types as well as into neural stem cells, cardiomyocytes, and liver cells.

Adult stem cells can be isolated through plasmapheresis. They are already used to treat hematological malignancies and to modify the side effects of cancer chemotherapy. Furthermore, autologous stem cells are being used in clinical trials in patients who have suffered myocardial infarction. Their use in several other conditions has not been validated or is experimental, despite some claims to the contrary (3).

Pluripotent stem cell lines can be derived from the inner cell mass of the 5- to 7-d-old blastocyst. However, human embryonic stem cell (hESC) research is ethically and politically controversial because it involves the destruction of human embryos. In the United States, the question of when human life begins has been highly controversial and closely linked to debates over abortion. It is not disputed that embryos have the potential to become human beings; if implanted into a womans uterus at the appropriate hormonal phase, an embryo could implant, develop into a fetus, and become a live-born child.

Some people, however, believe that an embryo is a person with the same moral status as an adult or a live-born child. As a matter of religious faith and moral conviction, they believe that human life begins at conception and that an embryo is therefore a person. According to this view, an embryo has interests and rights that must be respected. From this perspective, taking a blastocyst and removing the inner cell mass to derive an embryonic stem cell line is tantamount to murder (4).

Many other people have a different view of the moral status of the embryo, for example that the embryo becomes a person in a moral sense at a later stage of development than fertilization. Few people, however, believe that the embryo or blastocyst is just a clump of cells that can be used for research without restriction. Many hold a middle ground that the early embryo deserves special respect as a potential human being but that it is acceptable to use it for certain types of research provided there is good scientific justification, careful oversight, and informed consent from the woman or couple for donating the embryo for research (5).

Opposition to hESC research is often associated with opposition to abortion and with the pro-life movement. However, such opposition to stem cell research is not monolithic. A number of pro-life leaders support stem cell research using frozen embryos that remain after a woman or couple has completed infertility treatment and that they have decided not to give to another couple. This view is held, for example, by former First Lady Nancy Reagan and by U.S. Senator Orrin Hatch.

On his Senate website, Sen. Hatch states: The support of embryonic stem cell research is consistent with pro-life, pro-family values.

I believe that human life begins in the womb, not a Petri dish or refrigerator . To me, the morality of the situation dictates that these embryos, which are routinely discarded, be used to improve and save lives. The tragedy would be in not using these embryos to save lives when the alternative is that they would be discarded (6).

In 2001, President Bush, who holds strong pro-life views, allowed federal National Institutes of Health (NIH) funding for stem cell research using embryonic stem cell lines already in existence at the time, while prohibiting NIH funding for the derivation or use of additional embryonic stem cell lines. This policy was a response to a growing sense that hESC research held great promise for understanding and treating degenerative diseases, while still opposing further destruction of human embryos. NIH funding was viewed by many researchers as essential for attracting scientists to make a long-term commitment to study the basic biology of stem cells; without a strong basic science platform, therapeutic breakthroughs would be less likely.

President Bushs rationale for this policy was that the embryos from which these lines were produced had already been destroyed. Allowing research to be carried out on the stem cell lines might allow some good to come out of their destruction. However, using only existing embryonic stem cell lines is scientifically problematic. Originally, the NIH announced that over 60 hESC lines would be acceptable for NIH funding. However, the majority of these lines were not suitable for research; for example, they were not truly pluripotent, had become contaminated, or were not available for shipping. As of January 2009, 22 hESC lines are eligible for NIH funding. However, these lines may not be safe for transplantation into humans, and long-standing lines have been shown to accumulate mutations, including several known to predispose to cancer. In addition, concerns have been raised about the consent process for the derivation of some of these NIH-approved lines (7). The vast majority of scientific experts, including the Director of the NIH under President Bush, believe that a lack of access to new embryonic stem cell lines hinders progress toward stem cell-based transplantation (8). For example, lines from a wider range of donors would allow more patients to receive human leukocyte agent matched stem cell transplants (9).

Currently, federal funds may not be used to derive new embryonic stem cell lines or to work with hESC lines not on the approved NIH list. NIH-funded equipment and laboratory space may not be used for research on nonapproved hESC lines. Both the derivation of new hESC lines and research with hESC lines not approved by NIH may be carried out under nonfederal funding. Because of these restrictions on NIH funding, a number of states have established programs to fund stem cell research, including the derivation of new embryonic stem cell lines. California, for example, has allocated $3 billion over 10 yr to stem cell research.

Under President Obama, it is expected that federal funding will be made available to carry out research with hESC lines not on the NIH list and to derive new hESC lines from frozen embryos donated for research after a woman or couple using in vitro fertilization (IVF) has determined they are no longer needed for reproductive purposes. However, federal funding may not be permitted for creation of embryos expressly for research or for derivation of stem cell lines using somatic cell nuclear transfer (SCNT) (10,11).

Women and couples who undergo infertility treatment often have frozen embryos remaining after they complete their infertility treatment. The disposition of these frozen embryos is often a difficult decision for them to make (12). Some choose to donate these remaining embryos to research rather than giving them to another couple for reproductive purposes or destroying them. Several ethical concerns come into play when a frozen embryo is donated, including informed consent from the woman or couple donating the embryo, consent from gamete donors involved in the creation of the embryo, and the confidentiality of donor information.

Since the Nuremburg Code, informed consent has been regarded as a basic requirement for research with human subjects. Consent is particularly important in research with human embryos (13). Members of the public and potential donors of embryos for research hold strong and diverse opinions on the matter. Some consider all embryo research to be unacceptable; others only support some forms of research. For instance, a person might consider infertility research acceptable but object to research to derive stem cell lines or research that might lead to patents or commercial products (14). Obtaining informed consent for potential future uses of the donated embryo respects this diversity of views. Additionally, people commonly place special emotional and moral significance on their reproductive materials, compared with other tissues (15).

In the United States, federal regulations on research permit a waiver of informed consent for the research use of deidentified biological materials that cannot be linked to donors (16). Thus, logistically it would be possible to carry out embryo and stem cell research on deidentified materials without consent. For example, during IVF procedures, oocytes that fail to fertilize or embryos that fail to develop sufficiently to be implanted are ordinarily discarded. These materials could be deidentified and then used by researchers. Furthermore, if infertility patients have frozen embryos remaining after they complete treatment, they are routinely contacted by the IVF program to decide whether they want to continue to store the embryos (and to pay freezer storage fees), to donate them to another infertile woman or couple, or to discard them. If a patient chooses to discard the embryos, it would be possible to instead remove identifiers and use them for research. Still another possibility involves frozen embryos from patients who do not respond to requests to make a decision regarding the disposition of frozen embryos. Some IVF practices have a policy to discard such embryos and inform patients of this policy when they give consent for the IVF procedures. Again, rather than discard such frozen embryos, it is logistically feasible to deidentify them and give them to researchers.

However, the ethical justifications for allowing deidentified biological materials to be used for research without consent do not always hold for embryo research (13). For example, one rationale for allowing the use of deidentified materials is that the ethical risks are very low; there can be no breach of confidentiality, which is the main concern in this type of research. A second rationale is that people would not object to having their materials used in such a manner if they were asked. However, this assumption does not necessarily hold in the context of embryo research. A 2007 study found that 49% of women with frozen embryos would be willing to donate them for research (12). Such donors might be offended or feel wronged if their frozen embryos were used for research that they did not consent to. Deidentifying the materials would not address their concerns.

Frozen embryos may be created with sperm or oocytes from donors who do not participate any further in assisted reproduction or childrearing. Some people argue that consent from gamete donors is not required for embryo research because they have ceded their right to direct further usage of their gametes to the artificial reproductive technology (ART) patients. However, gamete donors who are willing to help women and couples bear children may object to the use of their genetic materials for research. In one study, 25% of women who donated oocytes for infertility treatment did not want the embryos created to be used for research (17). This percentage is not unexpected because reproductive materials have special significance, and many people in the United States oppose embryo research. Little is known about the wishes of sperm donors concerning research.

There are substantial practical differences between obtaining consent for embryo research from oocyte donors and from sperm donors. ART clinics can readily discuss donation for research with oocyte donors during visits for oocyte stimulation and retrieval. However, most ART clinics obtain donor sperm from sperm banks and generally have no direct contact with the donors. Furthermore, sperm is often donated anonymously to sperm banks, with strict confidentiality provisions.

As a matter of respect for gamete donors, their wishes regarding stem cell derivation should be determined and respected (13). Gamete donors who are willing to help women and couples bear children may object to the use of their genetic materials for research. Specific consent for stem cell research from both embryo and gamete donors was recommended by the National Academy of Sciences 2005 Guidelines for Human Embryonic Stem Cell Research and has been adopted by the California Institute for Regenerative Medicine (CIRM), the state agency funding stem cell research (18,19). This consent requirement need not imply that embryos are people or that gametes or embryos are research subjects.

Confidentiality must be carefully protected in embryo and hESC research because breaches of confidentiality might subject donors to unwanted publicity or even harassment by opponents of hESC research (20). Although identifying information about donors must be retained in case of audits by the Food and Drug Administration as part of the approval process for new therapies, concerns about confidentiality may deter some donors from agreeing to be recontacted.

Recently, confidentiality of personal health care information has been violated through deliberate breaches by staff, through break-ins by computer hackers, and through loss or theft of laptop computers. Files containing the identities of persons whose gametes or embryos were used to derive hESC lines should be protected through heightened security measures (20). Any computer storing such files should be locked in a secure room and password-protected, with access limited to a minimum number of individuals on a strict need-to-know basis. Entry to the computer storage room should also be restricted by means of a card-key, or equivalent system, that records each entry. Audit trails of access to the information should be routinely monitored for inappropriate access. The files with identifiers should be copy-protected and double encrypted, with one of the keys held by a high-ranking institutional official who is not involved in stem cell research. The computer storing these data should not be connected to the Internet. To protect information from subpoena, investigators should obtain a federal Certificate of Confidentiality. Human factors in breaches of confidentiality should also be considered. Personnel who have access to these identifiers might receive additional background checks, interviews, and training. The personnel responsible for maintaining this confidential database and contacting any donor should not be part of any research team.

hESC research using fresh oocytes donated for research raises several additional ethical concerns as well, as we next discuss (21).

Concerns about oocyte donation specifically for research are particularly serious in the wake of the Hwang scandal in South Korea, in which widely hailed claims of deriving human SCNT lines were fabricated. In addition to scientific fraud, the scandal involved inappropriate payments to oocyte donors, serious deficiencies in the informed consent process, undue influence on staff and junior scientists to serve as donors, and an unacceptably high incidence of medical complications from oocyte donation (22,23,24). In California, some legislators and members of the public have charged that infertility clinics downplay the risks of oocyte donation (19). CIRM has put in place several protections for women donating oocytes in state-funded stem cell research.

The medical risks of oocyte retrieval include ovarian hyperstimulation syndrome, bleeding, infection, and complications of anesthesia (25). These risks may be minimized by the exclusion of donors at high-risk for these complications, careful monitoring of the number of developing follicles, and adjusting the dose of human chorionic gonadotropin administered to induce ovulation or canceling the cycle (25).

Because severe hyperovulation syndrome may require hospitalization or surgery, women donating oocytes for research should be protected against the costs of complications of hormonal stimulation and oocyte retrieval (19). The United States does not have universal health insurance. As a matter of fairness, women who undergo an invasive procedure for the benefit of science and who are not receiving payment beyond expenses should not bear any costs for the treatment of complications. Even if a woman has health insurance, copayments and deductibles might be substantial, and if she later applied for individual-rated health insurance, her premiums might be prohibitive. Compensation for research injuries has been recommended by several U.S. panels (26) but has not been adopted because of difficulties calculating long-term actuarial risk and assessing intervening factors that could contribute to or cause adverse events.

Requiring free care for short-term complications of oocyte donation is feasible. In California, research institutions must ensure free treatment to oocyte donors for direct and proximate medical complications of oocyte retrieval in state-funded research. The term direct and proximate is a legal concept to determine how closely an injury needs to be connected to an event or condition to assign responsibility for the injury to the person who carried out the event or created the condition. Commercial insurance policies are available to cover short-term complications of oocyte retrieval. CIRM allows state stem cell grants to cover the cost of such insurance. The rationale for making research institutions responsible for treatment is that they are in a better position than individual researchers to identify insurance policies and would have an incentive to consider extending such coverage to other research injuries.

If women in infertility treatment share oocytes with researcherseither their own oocytes or those from an oocyte donortheir prospect of reproductive success may be compromised because fewer oocytes are available for reproductive purposes (21). In this situation, the physician carrying out oocyte retrieval and infertility care should give priority to the reproductive needs of the patient in IVF. The highest quality oocytes should be used for reproductive purposes (21).

As discussed in Section B. 2, in IVF programs some oocytes fail to fertilize, and some embryos fail to develop sufficiently to be implanted. Such materials may be donated to researchers. To protect the reproductive interests of donors, several safeguards should be in place (20). For the donation of fresh embryos for research, the determination by the embryologist that an embryo is not suitable for implantation and therefore should be discarded is a matter of judgment. Similarly, the determination that an oocyte has failed to fertilize and thus cannot be used for reproduction is a judgment call. To avoid any conflict of interest, the embryologist should not know whether a woman has agreed to research donation and also should receive no funding from grants associated with the research. Furthermore, the treating infertility physicians should not know whether or not their patients agree to donate materials for research.

Many jurisdictions have conflicting policies about payment to oocyte donors. Reimbursement to oocyte donors for out-of-pocket expenses presents no ethical problems because donors gain no financial advantage from participating in research. However, payment to oocyte donors in excess of reasonable out-of-pocket expenses is controversial, and jurisdictions have conflicting policies that may also be internally inconsistent (27,28).

Good arguments can be made both for and against paying donors of research oocytes more than their expenses (29). On the one hand, some object that such payments induce women to undertake excessive risks, particularly poorly educated women who have limited options for employment, as occurred in the Hwang scandal. Such concerns about undue influence, however, may be addressed without banning payment. For example, participants could be asked questions to ensure that they understood key features of the study and that they felt they had a choice regarding participation (19). Also, careful monitoring and adjustment of hormone doses can minimize the risks associated with oocyte donation (25). A further objection is that paying women who provide research oocytes undermines human dignity because human biological materials and intimate relationships are devalued if these materials are bought and sold like commodities (14,30).

On the other hand, some contend that it is unfair to ban payments to donors of research oocytes, while allowing women to receive thousands of U.S. dollars to undergo the same procedures to provide oocytes for infertility treatment (29). Moreover, healthy volunteers, both men and women, are paid to undergo other invasive research procedures, such as liver biopsy, for research purposes. Furthermore, bans on payment for oocyte donation for research have been criticized as paternalistic, denying women the authority to make decisions for themselves (31). On a pragmatic level, without such payment, it is very difficult to recruit oocyte donors for research.

In California, CIRM has instituted heightened requirements for informed consent for oocyte donation for research (19). The CIRM regulations go beyond requirements for disclosure of information to oocyte donors (19). The major ethical issue is whether donors appreciate key information about oocyte donation, not simply whether the information has been disclosed to them or not. As discussed previously, in other research settings, research participants often fail to understand the information in detailed consent forms (32). CIRM thus reasons that disclosure, while necessary, is not sufficient to guarantee informed consent. In CIRM-funded research, oocyte donors must be asked questions to ensure that they comprehend the key features of the research (19). Evaluating comprehension is feasible because it has been carried out in other research contexts, such as in HIV prevention trials in the developing world (33). According to testimony presented to CIRM, evaluation of comprehension has also been carried out with respect to oocyte donation for clinical infertility services.

Pluripotent stem cell lines whose nuclear DNA matches a specific person have several scientific advantages. Stem cell lines matched to persons with specific diseases can serve as in vitro models of diseases, elucidate the pathophysiology of diseases, and screen potential new therapies. Lines matched to specific individuals also offer the promise of personalized autologous stem cell transplantation.

One approach to creating such lines is through SCNT, the technique that produced Dolly the sheep. In SCNT, reprogramming is achieved after transferring nuclear DNA from a donor cell into an oocyte from which the nucleus has been removed. However, creating human SCNT stem cell lines has not only been scientifically impossible to date but is also ethically controversial (34,35).

Some people who object to SCNT believe that creating embryos with the intention of using them for research and destroying them in that process violates respect for nascent human life. Even those who support deriving stem cell lines from frozen embryos that would otherwise be discarded sometimes reject the intentional creation of embryos for research. In rebuttal, however, some argue that pluripotent entities created through SCNT are biologically and ethically distinct from embryos (36).

There are several compelling objections to using SCNT for human reproduction. First, because of errors during reprogramming of genetic material, cloned animal embryos fail to activate key embryonic genes, and newborn clones misexpress hundreds of genes (37,38). The risk of severe congenital defects would be prohibitively high in humans. Second, even if SCNT could be carried out safely in humans, some object that it violates human dignity and undermines traditional, fundamental moral, religious, and cultural values (34). A cloned child would have only one genetic parent and would be the genetic twin of that parent. In this view, cloning would lead children to be regarded more as products of a designed manufacturing process than gifts whom their parents are prepared to accept as they are. Furthermore, cloning would violate the natural boundaries between generations (34). For these reasons, cloning for reproductive purposes is widely considered morally wrong and is illegal in a number of states. Moreover, some people argue that because the technique of SCNT can be used for reproduction, its development and use for basic research should be banned.

Because of the shortage of human oocytes for SCNT research, some scientists wish to use nonhuman oocytes to derive lines using human nuclear DNA. These so-called cytoplasmic hybrid embryos raise a number of ethical concerns. Some opponents fear the creation of chimerasmythical beasts that appear part human and part animal and have characteristics of both humans and animals (39). Opponents may feel deep moral unease or repugnance, without articulating their concerns in more specific terms. Some people view such hybrid embryos as contrary to a moral order embodied in the natural world and in natural law. In this view, each species has a particular moral purpose or goal, which mankind should not try to change. Others view such research as an inappropriate crossing of species barriers, which should be an immutable part of natural design. Finally, some are concerned that there may be attempts to implant these embryos for reproductive purposes.

In rebuttal, supporters of such research point out that the biological definitions of species are not natural and immutable but empirical and pragmatic (40,41,42). Animal-animal hybrids of various sorts, such as the mule, exist and are not considered morally objectionable. Moreover, in medical research, human cells are commonly injected into nonhuman animals and incorporated into their functioning tissue. Indeed, this is widely done in research with all types of stem cells to demonstrate that cells are pluripotent or have differentiated into the desired type of cell. In addition, some concerns can be addressed through strict oversight (40), for example prohibiting reproductive uses of these embryos and limiting in vitro development to 14 d or the development of the primitive streak, limits that are widely accepted for other hESC research. Finally, some people regard repugnance per se an unconvincing guide to ethical judgments. People disagree over what is repugnant, and their views might change over time. Blood transfusion and cadaveric organ transplantation were originally viewed as repugnant but are now widely accepted practices. Furthermore, after public discussion and education, many people overcome their initial concerns.

Pluripotent stem cells can be derived from fetal tissue after abortion. However, use of fetal tissue is ethically controversial because it is associated with abortion, which many people object to. Under federal regulations, research with fetal tissue is permitted provided that the donation of tissue for research is considered only after the decision to terminate pregnancy has been made. This requirement minimizes the possibility that a womans decision to terminate pregnancy might be influenced by the prospect of contributing tissue to research. Currently there is a phase 1 clinical trial in Battens disease, a lethal degenerative disease affecting children, using neural stem cells derived from fetal tissue (43,44).

Somatic cells can be reprogrammed to form pluripotent stem cells (45,46), called induced pluripotential stem cells (iPS cells). These iPS cell lines will have DNA matching that of the somatic cell donors and will be useful as disease models and potentially for allogenic transplantation.

Early iPS cell lines were derived by inserting genes encoding for transcription factors, using retroviral vectors. Researchers have been trying to eliminate safety concerns about inserting oncogenes and insertional mutagenesis. Reprogramming has been successfully accomplished without known oncogenes and using adenovirus vectors rather than retrovirus vectors. A further step was the recent demonstration that human embryonic fibroblasts can be reprogrammed to a pluripotent state using a plasmid with a peptide-linked reprogramming cassette (47,48). Not only was reprogramming accomplished without using a virus, but the transgene can be removed after reprogramming is accomplished. The ultimate goal is to induce pluripotentiality without genetic manipulation. Because of unresolved problems with iPS cells, which currently preclude their use for cell-based therapies, most scientists urge continued research with hESC (49).

iPS cells avoid the heated debates over the ethics of embryonic stem cell research because embryos or oocytes are not used. Furthermore, because a skin biopsy to obtain somatic cells is relatively noninvasive, there are fewer concerns about risks to donors compared with oocyte donation. The Presidents Council on Bioethics called iPS cells ethically unproblematic and acceptable for use in humans (39). Neither the donation of materials to derive iPS cells nor their derivation raises special ethical issues.

Some potential downstream uses of iPS cell derivatives may be so sensitive as to call into question whether the original somatic cell donors would have agreed to such uses (50). iPS cells will be shared widely among researchers who will carry out a variety of studies with iPS cells and derivatives, using common and well-accepted scientific practices, such as:

Genetic modifications of cells

Injection of derived cells into nonhuman animals to demonstrate their function, including the injection into the brains of nonhuman animals.

Large-scale genome sequencing

Sharing cell lines with other researchers, with appropriate confidentiality protections, and

Patenting scientific discoveries and developing commercial tests and therapies, with no sharing of royalties with donors (51).

These standard research techniques are widely used in other types of basic research, including research with stem cells from other sources. Generally, donors of biological materials are not explicitly informed of these research procedures, although such disclosure is now proposed for whole genome sequencing (52,53).

Such studies are of fundamental importance in stem cell biology, for example to characterize the lines and to demonstrate that they are pluripotent. Large-scale genome sequencing will yield insights about the pathogenesis of disease and identify new targets for therapy. Injection of human stem cells into the brains of nonhuman animals will be required for preclinical testing of cell-based therapies for many conditions, such as Parkinsons disease, Alzheimers disease, and stroke.

However, some downstream research could also raise ethical concerns. For example, large-scale genome sequencing may evoke concerns about privacy and confidentiality. Donors might consider it a violation of privacy if scientists know their future susceptibility to many genetic diseases. Furthermore, it may be possible to reidentify the donor of a deidentified large-scale genome sequence using information in forensic DNA databases or at an Internet company offering personal genomic testing (54,55). Other donors may object to their cells being injected into animals. For example, they may oppose all animal research, or they may have religious objections to the mixing of human and animal species. The injection of human neural progenitor cells into nonhuman animals has raised ethical concerns about animals developing characteristics considered uniquely human (56,57). Still other donors may not want cell lines derived from their biological materials to be patented as a step toward developing new tests and therapies. People are unlikely to drop such objections even if the cell lines were deidentified or even if many years had passed since the original donation. Thus there may be a tension between respecting the autonomy of donors and obtaining scientific benefit from research, which can be resolved during the process of obtaining consent for the original donation of materials.

It would be unfortunate if iPS cell lines that turned out to be extremely useful scientifically (for example because of robust growth in tissue culture) could not be used in additional research because the somatic cell donor objected. One approach to avoid this is to preferentially use somatic cells from donors who are willing to allow all such basic stem cell research and to be contacted for future sensitive research that cannot be anticipated at the time of consent (50). Donors could also be offered the option of consenting to additional specific types of sensitive but not fundamental downstream research, such as allogenic transplantation into other humans and reproductive research involving the creation of totipotent entities.

Because these concerns about consent for sensitive downstream research also apply to other types of stem cells, it would be prudent to put in place similar standards for consent to donate materials for derivation of other types of stem cells. However, these concerns are particularly salient for iPS cells because of the widespread perception that these cells raise no serious ethical problems and because they are likely to play an increasing role in stem cell research.

Transplantation of cells derived from pluripotent stem cells offers the promise of effective new treatments. However, such transplantation also involves great uncertainty and the possibility of serious risks. Some stem cell therapies have been shown to be effective and safe, for example hematopoietic stem cell transplants for leukemia and epithelial stem cell-based treatments for burns and corneal disorders (58). However, there are some clinics around the world already exploiting patients hopes by purporting to offer effective stem cell therapies for seriously ill patients, typically for large sums of money, but without credible scientific rationale, transparency, oversight, or patient protections (58). Although supporting medical innovation under very limited circumstances, the International Society for Stem Cell Research has decried such use of unproven hSC transplantation.

These clinical trials should follow ethical principles that guide all clinical research, including appropriate balance of risks and benefits and informed, voluntary consent. Additional ethical requirements are also warranted to strengthen trial design, coordinate scientific and ethics review, verify that participants understand key features of the trial, and ensure publication of negative findings (59). These measures are appropriate because of the highly innovative nature of the intervention, limited experience in humans, and the high hopes of patients who have no effective treatments.

The risks of innovative stem cell-based interventions include tumor formation, immunological reactions, unexpected behavior of the cells, and unknown long-term health effects (58). Evidence of safety and proof of principle should be established through appropriate preclinical studies in relevant animal models or through human studies of similar cell-based interventions. Requirements for proof of principle and safety should be higher if cells have been manipulated extensively in vitro or have been derived from pluripotent stem cells (58).

Even with these safeguards, however, because of the highly innovative nature of the intervention and limited experience in humans, unanticipated serious adverse events may occur. In older clinical trials of transplantation of fetal dopaminergic neurons into persons with Parkinsons disease, transplanted cells failed to improve clinical outcomes (60,61). Indeed, about 15% of subjects receiving transplantation late developed disabling dyskinesias, with some needing ablative surgery to relieve these adverse events (60,61). Although the transplanted cells localized to the target areas of the brain, engrafted, and functioned to produce the intended neurotransmitters, appropriately regulated physiological function was not achieved. Participants in phase I trials may not thoroughly understand the possibility that hESC transplantation might make their condition worse.

Problems with informed consent are well documented in phase I clinical trials. Participants in cancer clinical trials commonly expect that they will benefit personally from the trial, although the primary purpose of phase I trials is to test safety rather than efficacy (62). This tendency to view clinical research as providing personal benefit has been termed the therapeutic misconception (32,63). Analyses of cancer clinical trials reveal that the information in consent forms generally is adequate. However, in early phase I gene transfer clinical trials, researchers descriptions of the direct benefit to participants commonly were vague, ambiguous, and indeterminate (64).

Participants in phase I stem cell-based clinical trials might overestimate their benefits and underestimate the risks. The scientific rationale for hSC transplantation and preclinical results may seem compelling. In addition, highly optimistic press coverage might reinforce unrealistic hopes.

Several measures may enhance informed consent in early stem cell-based clinical trials (59). First, researchers should describe the risks and prospective benefits in a realistic manner. Researchers need to communicate the distinction between the long-term hope for effective treatments and the uncertainty inherent in any phase I trial. Participants in phase I studies need to understand that the intervention has never been tried before in humans for the specific condition, that researchers do not know whether it will work as hoped, and that the great majority of participants in phase I studies do not receive a direct benefit.

Second, investigators in hESC clinical trials should discuss a broader range of information with potential participants than in other clinical trials. The doctrine of informed consent requires researchers to discuss with potential participants information that is pertinent to their decision to volunteer for the clinical trial (65). Generally, the relevant information concerns the nature of the intervention being studied and the risks and prospective benefits. However, in hESC transplantation, nonmedical issues may be prominent or even decisive for some participants. Individuals who regard the embryo as having the moral status of a person would likely have strong objections to receiving hESC transplants. Although this intervention might benefit them medically, such individuals might regard it as complicit with an immoral action. Thus researchers in clinical trials of hESC transplantation should inform eligible participants that transplanted materials originated from human embryos.

Third, and most important, researchers should verify that participants have a realistic understanding of the clinical trial (59). The crucial ethical issue about informed consent is not what researchers disclose in consent forms or discussions, but rather what the participants in clinical trials understand. In other contexts, some researchers have ensured that participants understand the key features of the trial by assessing their comprehension. In HIV clinical trials in developing countries, where it has been alleged that participants did not understand the trial, many researchers are now testing each participant to be sure he or she understands the essential features of the research (33). Such direct assessment of participants understanding of the study has been recommended more broadly in contexts in which misunderstandings are likely (26). We urge that such tests of comprehension be carried out in phase I trials of hSC transplantation (58,59).

Careful attention to consent in highly innovative clinical trials might prevent controversies later. In early clinical trials of organ transplantation, the implantable totally artificial heart, and gene transfer, the occurrence of serious adverse events led to allegations that study participants had not truly understood the nature of the research (66,67,68). The resulting ethical controversies brought about negative publicity and delays in subsequent clinical trials.

Human stem cell research raises some ethical issues that are beyond the mission of institutional review boards (IRBs) to protect human subjects, as well as the expertise of IRB members. There should be a sound scientific justification for using human oocytes and embryos to derive new human stem cell lines. However, IRBs usually do not carry out in-depth scientific review. Some ethical issues in hESC research do not involve human subjects protection, for example the concern that transplanting human stem cells into nonhuman animals might result in characteristics that are regarded as uniquely human.

An institutional SCRO with appropriate scientific and ethical expertise, as well as public members, should be convened at each institution to review, approve, and oversee stem cell research (18,69,70). The SCRO will need to work closely with the IRB and, in cases of animal research, with the Institutional Animal Care and Use Committee. Because of the sensitive nature of hSC research, the SCRO should include nonaffiliated and lay members who can ensure that public concerns are taken into account.

Sharing stem cells across institutions facilitates scientific progress and minimizes the number of oocytes, embryos, and somatic cells used. However, ethical concerns arise if researchers work with lines that were derived in other jurisdictions under conditions that would not be permitted at their home institution. Researchers and SCROs need to distinguish core ethical standards that are accepted by international consensusinformed consent and an acceptable balance of benefits and risksfrom standards that vary across jurisdictions and cultures. Using lines whose derivation violated core standards would erode ethical conduct of research by providing incentives to others to violate those standards.

The review process should focus on those types of hSC derivation that raise heightened levels of ethical concern (71). hSC lines derived using fresh oocytes and embryos require in-depth review because of concerns about the medical risks of oocyte donation, undue influence, and setbacks to the reproductive goals of a woman undergoing infertility treatment.

Dilemmas occur when donors of research oocytes receive payments in excess of their expenses and such payments are not permitted in the jurisdiction where the hSC cells will be used. For example, the United Kingdom enacted an explicit policy to allow such payment after public consultation and debate and provided reasons to justify its decision (72,73,74,75). Jurisdictions that ban payments should accept such carefully considered policies as a reasonable difference of opinion on a complex issue. Concerns about payment should be less if lines were derived from frozen embryos remaining after IVF treatment and donors were paid in the reproductive context. Such payments, which were carried out before donation for research was actually considered, are not an inducement for hESC research (71).

Other dilemmas arise with hESC lines derived from embryos using gamete donors. As previously discussed, explicit consent for the use of reproductive materials in stem cell research should be obtained from any gamete donors as well as embryo donors (13,76). An exception may be made to grandparent older lines derived from frozen embryos created before such explicit consent became the standard of care, for example before the 2005 National Academy of Sciences guidelines (76). Use of such older lines is appropriate because it would be unreasonable to expect physicians to comply with standards that had not yet been developed (71). It would also be acceptable to grandparent lines if gamete donors agreed to unspecified future research or gave dispositional control of frozen embryos to the woman or couple in IVF. However, the derivation should be consistent with the ethical and legal standards in place at the time the line was derived.

In summary, hSC research offers exciting opportunities for scientific advances and new therapies, but also raises some complex ethical and policy issues. These issues need to be discussed along with scientific challenges to ensure that stem cell research is carried out in an ethically appropriate manner.

This work was supported by National Institutes of Health (NIH) Grant 1 UL1 RR024131-01 from the National Center for Research Resources (NCRR) and NIH Roadmap for Medical Research and by the Greenwall Foundation. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH.

B.L. is co-chair of the California Institute for Regenerative Medicine Scientific and Medical Accountability Standards Working Group.

Disclosure Summary: The authors have no conflicts of interest to declare.

First Published Online April 14, 2009

Abbreviations: ART, Artificial reproductive technology; hESC, human embryonic stem cell; hSC, human stem cell; iPS cells, induced pluripotent stem cells; IRB, institutional review board; IVF, in vitro fertilization; SCNT, somatic cell nuclear transfer.

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Mesenchymal Stem Cell Therapy

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What kind of stem cells are these?

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Type 2 Diabetes Stem Cell Treatment Studies

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Stem Cell Therapy Research

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Stem cells are unspecialised cells in the body that have the potential to develop into specialised cell types (e.g. blood cells, muscle cells, nerve cells) that have been lost through illness or injury. Stem cells are being researched for their potential to treat various medical conditions, but this research is still at the early stages. In most cases, their use is controversial.

Stem cells can help with the growth or repair of body tissues.

There are different types, including:

The main benefits of stem cells are their ability to differentiate (transform) into any cell type, and their ability to repair damaged tissue. Because of this, researchers think they may have a role in treating a range of medical conditions.

Embryonic stem cells used in research are taken from excess human embryos produced during assisted-fertility programs. This results in the destruction of the embryos, raising many ethical questions.

Therapeutic cloning, which involves creating identical embryonic stem cells using an unfertilised human egg, is legal in Australia under very strict conditions.

Many stem cell treatments are still experimental and are not yet proven to be safe and effective. However, media reports about stem cell breakthroughs sometimes imply that experimental treatments are available. Furthermore, some stem cell clinics offer unproven treatments that may be harmful.

It is essential to research stem cell treatments thoroughly using trusted information sources, and to talk to your doctor.

The only approved stem cell treatment that has been established to be safe and effective is haematopoietic stem cell transplantation (using stem cells from umbilical cord blood or bone marrow) for people with blood and immune system conditions, such as leukaemia and lymphoma. Other uses are still experimental.

Areas of stem cell research and potential uses:

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Human Embryonic Stem Cells

Stem cells are undifferentiated cells that are capable of dividing for long periods of time and can give rise to specialized cells under particular conditions. Embryonic stem cells are a particular type of stem cell derived from embryos. According to US National Institutes of Health (NIH), in humans, the term embryo applies to a fertilized egg from the beginning of division up to the end of the eighth week of gestation, when the embryo becomes a fetus. Between fertilization and the eighth week of gestation, the embryo undergoes multiple cell divisions. At the eight-cell stage, roughly the third day of division, all eight cells are considered totipotent, which means the cell has the capability of becoming a fully developed human being. By day four, cells begin to separate and form a spherical layer which eventually becomes the placenta and tissue that support the development of the future fetus. A mass of about thirty cells, called the inner cell mass, forms at one end of the sphere and eventually becomes the body. When the sphere and inner cell mass are fully formed, around day 5, the pre-implantation embryo is referred to as a blastocyst. At this point the cells in the inner cell mass have not yet differentiated, but have the ability to develop into any specialized cell type that makes up the body. This property is known as pluripotency. As of 2009, embryonic stem cells refer to pluripotent cells that are generally derived from the inner cell mass of blastocysts.

In November 1998, two independent publications announced the first successful isolation and culture of pluripotent human stem cells. While working at the Wisconsin National Primate Research Center, located at the University of Wisconsin-Madison, James A. Thomson and his team of researchers cultured human embryonic stem cells from the inner cell mass of donated embryos originally produced for in vitro fertilization. The characteristics of the cultured cells were consistent with previously identified features in animal stem cells. They were capable of long-term self-renewal and thus could remain undifferentiated for long periods of time; they had particular surface markers; and they were able to maintain a normal and stable karyotype. Thomsons team also observed derivatives of all the three germ layersendoderm, mesoderm, and ectoderm. Since the three germ layers precede differentiation into all the cell types in the body, this observation suggested that the cultured cells were pluripotent. The team published Embryonic Stem Cell Lines Derived from Human Blastocysts, in the 6 November Science issue. Soon afterwards, a research team led by John D. Gearhart at the Johns Hopkins School of Medicine, published Derivation of Pluripotent Stem Cells from Cultured Human Primordial Germ Cells in Proceedings of the National Academy of Science. The paper detailed the process by which pluripotent stem cells were derived from gonadal ridges and mesenteries extracted from aborted five-to-nine week old human embryos. Gearhart and his team noted the same observations as Thomsons team. Despite coming from different sources, according to NIH, the resultant cells seem to be the same.

The largest source of blastocysts for stem cell research comes from in vitro fertilization (IVF) clinics. Used for reproductive purposes, IVF usually produces an abundance of viable blastocysts. Excess blastocysts are sometimes donated for research purposes after obtaining informed consent from donors. Another potential method for producing embryonic stem cells is somatic cell nuclear transfer (SCNT). This has been successfully done using animal cells. The nucleus of a differentiated adult cell, such as a skin cell, is removed and fused with an enucleated egg, an egg with the nucleus removed. The egg, now containing the genetic material from the skin cell, is believed to be totipotent and eventually develops into a blastocyst. As of mid-2006, attempts to produce human embryonic stem cells using SCNT have been unsuccessful. Nonetheless, scientists continue to pursue this method because of the medical and scientific implications of embryonic stem cells lines with an identical genetic makeup to particular patients. One problem faced in tissue transplants is immune rejection, where the host body attacks the introduced tissue. SCNT would be a way to overcome the incompatibility problem by using the patients own somatic cells.

Recent discoveries in cultivating human embryonic stem cells may potentially lead to major advancements in understanding human embryogenesis and medical treatments. Previously, limitations in access and environmental control have stunted research initiatives aimed at mapping out the developmental process. Insights into differentiation factors may lead to treatments into such areas as birth defects. Manipulation of the differentiation process may then lead to large supplies of stem cells for cell-based therapies on patients with Parkinsons disease, for example. In theory adult stem cells can also be cultivated for such purposes, but isolating and identifying adult stem cells has been difficult and the prospects for treatment are more limited than using embryonic stem cells.

Despite the potential benefits that may come about through human embryonic stem cell research, not everyone in the public embraces it. Several ethical debates surround this newly developing research field. Much of the debate stems from differing opinions on how we should view embryos: is an embryo a person? Should an embryo be considered property? Ethical concerns in embryonic stem cell research include destroying human blastocysts, laws surrounding informed consent, and particularly for SCNT, misapplication of techniques for reproductive cloning. For the latter concern, SCNT does produce a blastocyst which contains stem cell clones of an adult cell, but the desired application is in growing replacement tissues. Still, a portion of the public fears the hypothetical one day, when someone decides to use SCNT to develop and raise a human clone.

The public debate continues, advancing along with the changes in the field. As of 2006, public opinion polls showed that majority of religious and non-religious Americans now support embryonic stem cell research, but opinions remain divided over whether it is legitimate to create or use human blastocysts solely for research.

Wu, Ke, "Human Embryonic Stem Cells".

(2010-09-13). ISSN: 1940-5030 http://embryo.asu.edu/handle/10776/2055.

Arizona State University. School of Life Sciences. Center for Biology and Society. Embryo Project Encyclopedia.

Arizona Board of Regents Licensed as Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported (CC BY-NC-SA 3.0) http://creativecommons.org/licenses/by-nc-sa/3.0/

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Human Embryonic Stem Cells | The Embryo Project Encyclopedia

Representatives of three of the worlds major religions tangled over the beginnings of human life, the disposal of surplus embryos from in vitro fertilization clinics, and the conduct of embryonic stem cell research Wednesday (March 14) at Harvard Divinity School.

Panelists at the event, representing Christianity, Judaism, and Islam, each briefly presented their faiths teachings about the beginnings of human life and then embarked on a lively discussion about embryonic stem cell research.

The conservative Christian view that human life is created at conception contrasted with the view common among Jews that an embryo doesnt become human until 40 days after conception, and the similar Muslim view that human life begins when the soul enters the developing baby sometime between 40 days and 120 days after conception.

The different beliefs in the timing of when a developing embryo becomes a human likely accounts for different levels of acceptance for embryonic stem cell research, which is supported in the Jewish community, is accepted in many Muslim countries, yet is opposed by the Roman Catholic Church and some Protestant denominations.

The panel featured Eric Cohen, director of the Bioethics and American Democracy Program at the Ethics and Public Policy Center in Washington, D.C., who presented the Jewish point of view; Omar Sultan Haque, a Muslim theologian at Harvard Medical School; John Davis, a Presbyterian minister and professor of systematic theology and Christian ethics at Gordon-Conwell Theological Seminary; and Llewellyn Smith of the Andover/Newton Theological School and a minister with the United Church of Christ.

Harvard Stem Cell Institute faculty members Willy Lensch and Jerome Ritz also participated, providing clarification on scientific points.

Harvard Stem Cell Institute executive director Brock Reeve introduced the event, saying that exploring ethical matters related to stem cell research is an important part of the institutes mission. Philip Clayton, visiting professor of science and religion at Harvard Divinity School, moderated the event.

Clayton said that the ethical issues surrounding embryonic stem cell research have made it one of the best-known and highest-stakes ethical debates of our times. Supporters, Clayton said, insist that the promise of stem cell research to cure debilitating diseases means the research must go forward. Opponents, however, say that the need to destroy human embryos as a source of stem cells makes the cost of that research too high.

Though Cohen presented the Jewish belief that 40 days after conception is a critical threshold for human life, he said he disagrees with that notion. He believes that medical advances that allow embryos to live outside the human body and scientific knowledge that 40 days after conception is not a significant time in human development have put humanity in a situation unanticipated by religious tradition.

Cohen, who has served as an adviser to President George Bushs Council on Bioethics, said he believes human life must be respected from conception and warned of the dangers of defining a class of human beings as unworthy of life.

I think we need to see the embryos as God sees us. In the eyes of God, we dont seem like much, Cohen said.

Cohens views were echoed in many ways by Davis, who said a person should be defined not as one who has developed consciousness already, but as one capable of developing consciousness. Cohen said that societys view of who is a person has undergone considerable evolution over time, incorporating, for example, ethnic groups that were once excluded. He argued that it is time for it to evolve again and begin to include developing humans from the time of conception, which he argued are excluded, like other groups in history, because they dont look like us.

Haque said that views on the subject in Islam are still evolving, given that the Koran doesnt address the issue directly. The idea of ensoulment, he said, is usually thought to occur at either 40 days or 120 days, and is based on intuitive signs of life in the developing embryo. While there is a strong prohibition against reproductive cloning, with severe penalties in some countries, therapeutic cloning is generally tolerated.

Haque said he doesnt necessarily agree with the idea of ensoulment but supports embryonic stem cell research, saying he doesnt see why embryos created and frozen to help infertile couples in in vitro fertilization (IVF) clinics should be discarded as medical waste. Despite arguments to the contrary, he said, even people who say an embryo should be treated as a full human life make distinctions by allowing abortions when the mothers life is in danger.

How is that possible if both lives are equal? Haque said.

Smith said the United Church of Christ doesnt object to research on blastocysts, as long as its conducted with respect and not done for reproductive purposes. But the church also believes there needs to be a robust debate on the issue. There are concerns from some parts of the church that the benefits of stem cell research be broadly shared, regardless of wealth or social status, and concern about unintended consequences, such as uncontrolled reproduction as in cancer cells.

I think we have a true moral dilemma that our tradition and our scriptures do not fully address, Smith said. Were a long way from a clear answer.

When asked about common ground among their views, panelists said that all agree that human life must be respected and that disease must be treated, but they disagree about what constitutes a human life and at what cost must disease be treated.

Haque said people often talk about human life as if it is invaluable and to be protected at all costs, but belie those words in everyday decisions, such as those to go to war, that cost human lives.

Haques assertion prompted Cohen to suggest the discussants focus on stem cells and not military policy.

Lets keep the Iraq War out of this. Stem cells are hard enough, Cohen said.

Cohen argued that because embryonic stem cell research has yet to fulfill its promise, the issue isnt even as clear as trading blastocysts for a cure for disease.

Its not even a debate of [curing] one person who is sick versus an embryo. It destroys lots of embryos on the speculation that research will one day lead to a cure, Cohen said.

Davis argued that the destruction of blastocysts may carry a societal cost, since we dont know whether, if implanted, one could develop into an influential leader. Davis said he believes the issue is essentially a line-drawing problem and that the burden of drawing the appropriate line determining when a potential human life can be used to benefit others falls on those who would use it.

Cohen and Davis both acknowledged that the problem stems from our societys acceptance of the practice of in vitro fertilization, which creates thousands of unused blastocysts in the process.

Cohen said he thinks the nation should have a renewed debate over IVF, focusing on alternate technologies at use in other nations that produce far fewer surplus embryos.

Read more:
Stem cells, through a religious lens Harvard Gazette

Genetic Engineering is a technology that alters the genetic structure of an organism either by removing or adding DNA.Genetic Engineering, also called genetic modification or genetic manipulation controls the living being's genes using biotechnology. It is an arrangement of innovations used to change the hereditary forms of cells, including the exchange of qualities inside and across species limits to create enhanced or novel living beings. Genetic engineering could potentially fix severegenetic disorders in humans by replacing the defective gene with a functioning one.

Genetic Engineering has been connected in various fields of research, medicine, industrial biotechnology, and agriculture. In research, GMOs are utilized to contemplate quality capacity and articulation through loss of function, gain of function, tracking and expression experiments. By thumping out genes responsible for specific conditions it is possible to create animal model organisms of human diseases. And in addition to producing hormones, immunizations and different drugs genetic engineering can fix hereditary diseases through quality treatment. Similar strategies that are utilized to create medications can likewise have mechanical applications, for example, producing enzymes for detergents, cheeses, and different products.

Genetic engineering as a course is studied at the graduate, postgraduate and doctoral levels. Genetic Engineering is rather a new field of science but with the recent advancement in Biotechnology and the interest of scientists in this particular field, the course in Genetic Engineering is present in almost every major science university. The B.Sc in Genetics or B.Tech in Genetic Engineering course deals with multiple types of problems related to the medical field like the human genome and agriculture. Several institutes also offer Genetic Engineering as an elective course of study in B.Tech Biotechnology programs.

Delhi Technological University, Delhi

Aryabhatta Knowledge University, Patna

SRM University, Chennai

Bharat University, Chennai

Indian Institute of Science, Bangalore

Sharda University, Greater Noida

India has some of the very prestigious institutes engaged in research in the field of Genetics. Candidates can pursue research in these institutes in Genetic Engineering and its various sub-fields.

Genetic engineering is the study of genes and the science of heredity. Genetic engineers or geneticists study living organisms ranging from human beings to crops and even bacteria. These professionals also conduct researches which is a major part of their work profile. The experiments are conducted to determine the origin and governing laws of a particular inherited trait. These traits include medical conditions, diseases, etc. The study is further used to seek our determinants responsible for the inherited trait.

Genetic engineers or Geneticists keep on finding ways to enhance their work profile depending on the place and organization they are working with. In manufacturing, these professionals will develop new pharmaceutical or agricultural products while in a medical setting, they advise patients on the diagnosed medical conditions that are inherited and also treat patients on the same.

Skill sets for Genetic engineers or Geneticists

Strong understanding of scientific methods and rules

complex problem solving and critical thinking

ability to use computer-aided design (CAD)

graphics or photo imaging

PERL, Python

word processing software programs

excellent mathematical, deductive and inductive reasoning, reading, writing, and oral comprehension skills

ability to use lasers spectrometers, light scattering equipment, binocular light compound microscopes, benchtop centrifuges, or similar laboratory equipment

Typical responsibilities of a Genetic Engineering or Geneticist includes:

When a genetic engineer gains a year of experience, one of the regions they can indulge in is hereditary advising, which includes offering data, support, and counsel on hereditary conditions to your patients.

An individual aspiring to pursue a professional degree in Genetic Engineering can begin the B.Sc in Genetics or B.Tech course after his/her 10+2 Science with Physics, Chemistry, Maths, and Biology.

Admission to BTech in Genetic Engineering is made through entrance tests conducted by various universities or through the scores of national engineering entrance examinations like JEE for IITs/NITs & CFTIs across the country.

Genetic Engineering professionals require a bachelors or masters degree in Genetic Engineering or Genetic Sciences for entry-level careers. In any case, a doctoral qualification is required for those looking for free research professions. Important fields of study in Genetic Engineering incorporate natural chemistry, biophysics, or related fields.

Genetic Engineers require a solid comprehension of logical techniques and guidelines, and in addition complex critical thinking and basic reasoning aptitudes. Phenomenal scientific, deductive, and inductive thinking aptitudes, and in addition perusing, composing, and oral cognizance abilities are additionally expected to work in this field.

A semester-wise breakup of the B.Tech Genetic Engineering course is tabulated below

SEMESTER I

SEMESTER II

Mathematics 1

Mathematics 2

English

Material Science

Physics

Principles of Environmental Science

Chemistry

Biochemistry

Basic Engineering 1

Basic Engineering 2

-

Cell Biology

-

Value Education

SEMESTER III

SEMESTER IV

Enzyme Technology

Basic Molecular Techniques

Genetics & Cytogenetics

Molecular Biology

Immunology

Stoichiometry and Engineering Thermodynamics

Microbiology

Bio-press Principles

Mechanical Operations & heat Transfer

Biostatistics

German Language Phase 1/French Language Phase 1/Japanese Language Phase 1

German Language Phase 2/Japanese Language Phase 2/French Language Phase 2

-

SEMESTER V

SEMESTER VI

Advanced Molecular Techniques

Recombinant DNA Technology

Functional Genomics and Microarray Technology

Bioinformatics

Momentum Transfer

Chemical Reaction Engineering

Bioprocess Engineering

Gene Therapy

Biophysics

Biosensors and Biochips

Plant Tissue Culture and Transgenic Technology

-

Personality Development

-

SEMESTER VII

SEMESTER VIII

Bio-separation Technology

Project Work

Animal Cell Culture and Transgenic Technology

Bio-Safety, Bio-ethics, IPR & Patients

Nano-biotechnology in Healthcare

-

Stem Cell Biology

-

Aspirants who wish to join the engineering industry as genetic engineers can apply for the following jobs profiles available:

JOB PROFILE

JOB DESCRIPTION

Genetic Engineer

They apply their knowledge of engineering, biology, and biomechanical principles to the design, development, and evaluation of biological and health systems and products, such as artificial organs, prostheses, instrumentation, medical information systems, and health care and management.

Lecturer/Professor

They teach at the undergraduate and graduate levels in areas allocated and reviewed from time to time by the Head of Department.

Research Scientist

They are responsible for designing, undertaking, and analyzing information from controlled laboratory-based investigations, experiments and trials.

Scientific/Medical Writer

The research, prepare and coordinate scientific publications. The medical writer is responsible for researching, writing, and editing clinical/statistical reports and study protocols, and summarizing data from clinical studies.

Most of the engineering educational institutes shortlist candidates for admission into the BTech in Genetic Engineering course based on engineering entrance exams. These entrance exams are either conducted at the national level like JEE or held in-house by various engineering institutes in the country. Some of the popular engineering entrance examinations aspirants should consider appearing for admissions to UG and PG level Automobile engineering courses are:

Genetic Engineering is particularly the newly evolving field of science with enormous job opportunities. India has become a global hub of research in genetic engineering owing to its vast prospect of treating diseases of genetic disorders. Genetic engineering professionals can work in the filed of medicine, research, industry, and agriculture. Fresh graduates working as research associates can earn anything between INR 3-5 lakh per annum while the salary of scientists generally lies in the range of 9-15 lakh per annum.

India is home to some of the best companies working in the field of Genetic Engineering. Below is provided a list of some of the companies with which candidates can work in the field of research.

Q. Which college is best for genetic engineering?

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Genetic Engineering - Courses, Subjects, Eligibility ...

Do you want a boy or a girl? can be an awkward question.

But in certain circles, its a question thats asked every day. Take agriculture. In a perfect world, most cows would only birth females. Chicks would grow up to be all hens. Sexing a farm animal when theyre at a young age wouldnt be a thingespecially when it means male animals, without the ability to produce milk or eggs, are often culled at a young age to preserve resources.

There might be a better way. This month, a team tapped into the power of CRISPR to control the sex of the offspring in mice. By splicing CRISPR components into the parents genome, the team was able to flip onor offa switch that nearly perfectly determined the sex of their litters.

Unlike previous attempts, the baby mice could go on to have litters of their own of both sexes. The targeted gene used for the edit is conserved across evolution, suggesting the technique could work in more animals than just mice.

But its controversial. Essentially, the technique selectively kills off embryos of a certain sex, which immediately raises ethical red flags. For now, scientists arent concerned about the technology being used in humans due to its complexity. But the study is the latest to showcase biotechs increasing ability to manipulate reproduction.

Its an impressive result and a state-of-the-art solution to producing single-sex species, said Dr. Ehud Qimron at Tel Aviv University, who was not involved in the work.

Skewing the sex of offspring is nothing new. For over a decade, scientists have gradually hijacked the mosquito genome with gene drives to rewrite evolution. The idea is that the genetic edit would override natural selection, spreading across subsequent generations into a dominant gene. Instead of a genes usual 50-50 chance of inheritance, artificial gene drives have a far higher chance of infiltrating the next generation, fundamentally changing a species genetic code. When its a gene that biases the sex of their offspring, a species could gradually only have one sex, leading to their extinction.

Its a doomsday plan with potentially massive benefits, such as curbing malaria. Because female mosquitoes are generally the carrier for the disease, a gene drive that leads to only males is a sure-fire way to reduce transmission. In one study, within a dozen generations, the genetic edit was sufficient to collapse a whole colony of mosquitoes in the lab. Similar studies have been tried in mice.

Its not a perfect solution. The gene edit is powerfulmaybe too much so. With farm animals, the goal isnt to eradicate a species, but rather to bias the sex of the animal towards one side and increase animal welfare. Animal and animal products are used globally, and ethical discussions regarding animal usage are ongoing, said the authors. Over 100,000 male calves are culled each year, and stats for other common farm animals paint a similarly uncomfortable picture.

The new study took a different approach. With CRISPR, the team skewed the sex of only the next generation in mice, allowing the same-sex litters to eventually reproduce normally.

CRISPR has two parts: an RNA guide (the bloodhound that sniffs out the target gene) and Cas9 (a scissor protein that physically cuts the gene). Usually, the two components are encoded into a single carrier, dubbed a vector, and inserted into a cell or animal. By targeting a gene that is essential for reproduction, for example, its then possible to trigger spontaneous failed pregnancies in animals.

But how does that help with sex selection? Let me explain.

The first step was to find a gene critical for embryo survivalone that when disrupted causes synthetic lethality. The team honed in on Top1, well known for its role in DNA repair. Cutting the gene triggers embryos to fail at a very early stage, when theyre just 8 to 16 cells, not yet implanted into the uterine wall and far from viable.

The team then engineered a CRISPR system that targets the start codons of Top1a chunk of DNA that acts as an on switch to activate the gene. Heres the clever part. They split the two components of CRISPR into two vectors.

One part, which carries the genetic code for a guide RNA that targets Top1, was then inserted into a female mouses X chromosome. The other vector, carrying the code for Cas9 scissors, was edited into the males Y chromosome.

When combined, the two components meet up like peanut butter and jelly, forming the full recipe to disrupt Top1. This can only happen in X/Y embryosthose that define maleand so selectively interrupt these embryos from developing. X/X, or genetically female embryos, are spared, as they only contain half of the CRISPR mechanism. The system is flexible. If Cas9 scissors were attached to the males X chromosome, all X/X embryos were eliminated before they grew to 16 cells.

The efficiency of the edit was crazy at 100 percent. Mice born from these genetically-edited parents were completely normal, with a hefty body size and in larger numbers than normally expected, suggesting the edit may cause less stress on the mother. Unlike those born using gene drives, the mice grew up to have perfectly normal litters with both male and female offspring.

The results are a long time in the making. Back in 2019, a team led by Dr. Udi Qimron at Tel Aviv University used CRISPR to produce mice in which 80 percent of the offspring were females. With the new study, the efficacy leaps to 100 percent, with the choice towards either sex. If further tested in farm animals, the technique could be a boost to both animal welfare and conservation.

Its not an entirely comfortable solution for some. To Sue Leary, president of the non-profit Alternatives Research & Development Foundation, You cant solve an ethical problem with another ethical problem, which is genetic engineering. And given the animosity towards GMOs, the new technology, regardless of efficacy, may be dead in the water.

For now, the CRISPR edits arent feasible in humans due to their complexity. Whats clear, though, is that weve begun parsing the biological machinery behind gender selection. Add in recent work on genetically-engineered embryos, or eggs and sperm from stem cells, and were on the fast track for CRISPR to completely change our current conception of reproduction.

Image Credit: Graphic Compressor/Shutterstock.com

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Scientists Used CRISPR Gene Editing to Choose the Sex of Mouse Pups - Singularity Hub

NEW YORK, December 21 -- A new report released by The Hastings Center, a leading ethics research institute, finds that the complex issues raised by releasing gene-edited species into the wild demand deep and broad public engagement. The report, Gene Editing in the Wild: Shaping Decisions Through Broad Public Deliberation, provides a path forward to move decision-making from the realm of experts to a more inclusive, values-based approach using the technique of public deliberation or deliberative democracy.

The goals of gene editing in the wild efforts are wide-ranging, and the benefits potentially transformative--such as preventing mosquitoes from spreading disease. But this work poses major trade-offs that require the publics consideration.

The reports twelve essays take up fundamental questions: how should public deliberation be designed? Who should participate? How should deliberation be linked to policy?

The introductory essay, Public Deliberation About Gene Editing in the Wild, summarizes the key design elements that can improve broad public deliberations about gene editing in the wild: Framing the question and deciding when to hold broad public deliberation, choosing participants, addressing power, and accounting for and capturing perspectives that are hard to express. The introduction was written by the special report editors: Michael K. Gusmano, Gregory E. Kaebnick, Karen J. Maschke, Carolyn P. Neuhaus, and Ben Curran Wills.

Regulating Gene Editing in the Wild: Building Regulatory Capacity to Incorporate Deliberative Democracy, by Karen J. Maschke and Michael K. Gusmano, says that there has not been enough attention to how we should connect public deliberation to the existing regulatory process. The authors argue that, while federal agencies may have capacity to undertake public deliberative activities, there may not be sufficient political support for them to do so.

Deliberative Public Consultation via Deliberative Polling: Criteria and Methods, by James S. Fishkin, makes the case that Deliberative Polling, an approach developed by the author, can be usefully employed to engage representative samples to deliberate in depth in controlled experiments so as to yield a picture of the publics considered judgments. Another it can be cost-effectively conducted online.

The Decision Phases Framework for Public Engagement: Engaging Stakeholders about Gene Editing in the Wild, by S. Kathleen Barnhill-Dilling, Adam Kokotovich, and Jason A. Delborne, puts forth a framework for shaping public engagement that tackles when and whom to engage on genetic engineering questions.

Empowering Indigenous Knowledge in Deliberations on Gene Editing in the Wild, by Riley Taitingfong and Anika Ullah, identifies Indigenous peoples as key stakeholders in decisions about gene-editing in the wild and argues that engagement activities need not only include Indigenous peoples but also should be designed, conducted, and analyzed in ways that confront longstanding power imbalances that dismiss Indigenous expertise.

The special report grew out of a Hastings Center project funded by the National Science Foundation, The complete report is available for download here.

For more information, contact:

Susan Gilbert or Mark Cardwellcommunications@thehastingscenter.org845-424-4040, ext. 244

Systematic review

Not applicable

Gene Editing in the Wild: Shaping Decisions through Broad Public Deliberation

15-Dec-2021

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Report calls for broad public deliberation on releasing gene-edited species in the wild - EurekAlert

RNA and DNA extraction plays a crucial role in cancer genetic studies, which involves mutation analysis, comparative genomic hybridization, and microsatellite analysis. The rising incidences of cancer globally are creating a need for the advanced RNA and DNA extraction kit and are expected to drive market growth in the coming years.

Based on the product, the market is expected to segregate into RNA extraction kit and DNA extraction kit. Of these, the DNA extraction kit segment is expected to account for the leading share in the overall RNA and DNA extraction kit market. Additionally, the applications of DNA extraction kits mainly in the genetic engineering of animals and plants in pharmaceutical manufacturing. This is expected to fuel growth of RNA and DNA extraction kit market.

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Global RNA and DNA Extraction Kit Market: Notable Developments

Some of the most prominent competitors operating in the competitive landscape of global RNA and DNA extraction kit market include

Global RNA and DNA Extraction Kit Market: Drivers and Restraints

The rise and progress in customized drug have helped social insurance experts create exact sub-atomic focused on treatment dependent on a person's hereditary cosmetics and prescient information explicit to patients. The advancement of customized medication requires genome-mapping investigations of separated cells, which can be completed with the assistance of DNA and RNA extraction kits. DNA extraction kits are utilized to recognize quality polymorphisms identified with sickness or medication digestion though RNA extraction kits are utilized to break down RNA combination in separated cells. With the expanding appropriation of customized prescription, the demand for RNA and DNA extraction kits will likewise develop.

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There is a developing rate of malignant growth over the globe. The inside and out understanding of tumor hereditary qualities given by trend-setting innovations in malignant growth research has empowered the advancement of novel treatments to battle disease-causing qualities. The virtue, amount, and nature of separated RNA assume a huge job in the accomplishment of RNA examination and examination and consequent capacity of specific quality articulation. RNA extraction likewise helps in recognizing circulating tumor cells (CTCs) and non-intrusive observing of cutting edge malignant growths.

Global RNA and DNA Extraction Kit Market: Regional Outlook

On the basis of region, the RNA and DNA extraction kit market is segmented into North America, Europe, Latin America, Asia Pacific, and the Middle East & Africa. Of these, North America is expected to dominate the global RNA and DNA extraction kit market owing to robust innovation procedures running in the region. This factor is expected to offer robust growth opportunities to key players in RNA and DNA extraction kit market. Additionally, increasing demand for the automated systems coupled with the rising need for the RNA and DNA extraction kit across the extraction kits especially in the medical diagnosis is expected to drive growth of the market in coming years.

TMR Research is a leader in developing well-researched reports. The expertise of the researchers at TMR Research makes the report stand out from others. TMR Research reports help the stakeholders and CXOs make impactful decisions through a unique blend of innovation and analytical thinking. The use of innovation and analytical thinking while structuring a report assures complete and ideal information of the current status of the market to the stakeholders.

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RNA and DNA Extraction Kit Market Study | Know the Post-Pandemic Scenario of the Industry - BioSpace

Vitamin A deficiency (VAD) has killed millions of children in less-developed countries for at least the last three decadesroughly 2 million annually in the early 1990s alone (14). Although the number is declining, it was estimated to be 266,200 (4) at the start of the millennium.

Widespread consumption of the genetically modified rice variety known as Golden Rice offers a potent and cost-effective strategy to combat vitamin A deficiency. Image credit: International Rice Research Institute; photo licensed under CC BY 2.0.

The consumption of the genetically modified rice variety known as Golden Rice (GR) offers a potent and cost-effective strategy to combat VAD. But this innovation has been cast aside owing to fear or false accusations, resulting in numerous lives needlessly lost (13). With the recent exception of the Philippines, governments have not approved the cultivation of GR (5). We believe it should be broadly approved and given the opportunity to save and improve lives.

In high-income nations where populations have access to a diversity of foods, VAD is rare. In many low-income nations, however, populations have limited access to foods rich in vitamin A or beta-carotene, a vitamin A precursor; hence, VAD rates can be dangerously high in children. There have been recent improvements: from 1991 to 2013, the VAD rate among children in low- and middle-income countries declined from 39% to 29%, with notable improvements among children in East and Southeast Asia (4). However, children in sub-Saharan Africa and South and Southeast Asia continue to disproportionately experience VAD and its associated risks: infectious and diarrheal diseases, irreversible blindness and other sensory losses, and premature death (1, 4, 6).

VAD has not been eradicated despite a variety of strategies used globally, including education on the value of dietary diversity, promotion of home gardens and maternal breastfeeding of infants, and community health programs including vitamin A supplementation with syrups or capsules (7). Principally, VAD is caused by insufficient dietary diversity, a result of poverty and agronomic and market constraints. Animal source foods and many kinds of produce are unavailable or expensive in local markets. Conversely, white rice or other cereal grains are easily available and inexpensive but primarily contain carbohydrates while lacking sufficient micronutrient levels.

GR, developed first in the 1990s and then modified in 2004 with transgenes from maize and a common soil bacterium Erwinia uredovora, could be an important public health intervention for VAD populations worldwide. This transgenic, or genetically modified, rice produces beta-carotene, a precursor to vitamin A, in the normally white endosperm (8) and has proven an effective source of vitamin A in humans (9). GR* is now awaiting final approval in Bangladesh. In July 2021, it was approved for cultivation in the Philippines. Other countries will likely follow.

A recent study has estimated that substituting conventional rice for GR could provide 89% to 113% and 57% to 99% of the recommended vitamin A requirement for preschool children in Bangladesh and the Philippines, respectively (10). Even if there were no other sources of vitamin A in the diets, this boost in dietary beta-carotene could do much to prevent diseases associated with VAD.

GR is also financially viable. In Bangladesh, the current practice of fortifying rice with vitamin A and zinc using food additives, although supported by the World Food Programme, increases the cost of rice by 5% to 6% and is applied to only about 1 million metric tonnes of rice of the roughly 25 million metric tonnes produced in Bangladesh per year (11). GR, by contrast, poses no extra cost to governments, growers, or consumers in comparison with white rice.

Meanwhile, VAD has continued to cause severe illness and death among certain populations worldwide, especially children (12). The total estimated deaths from VAD-related diarrheal diseases and measles in children under five years of age in 2013 was 94,500 and 11,200, respectively, totaling 105,700 deaths across the world (4). Had GR become a part of diets in vulnerable populations worldwide, a portion of these lives might have been saved. Hopefully, approval of the commercialization of GR in the Philippines will provide impetus for Bangladesh and other nations with high VAD rates to provide poor consumers with an option that may save lives and improve health.

Those who oppose transgenic or genetically modified organisms raised concerns that led policymakers to delay the approval of the technologies (13). One argument relates to biotechnology company profits. But because the GR technology to the public sector is available at no cost for humanitarian uses, this concern is irrelevant. There are no limitations, except export, on GR use: replanting or selling or giving away seed, or polishing for consumption or sale.

Greenpeace summarized a food security-related objection to GR in a 2012 statement (14): If introduced on a large scale, GR can exacerbate malnutrition and ultimately undermine food security. The implication: GR will worsen malnutrition because it leads to a diet based on one staple. However, the replacement of traditional rice with GR would not exclude the development of diversified diets; in the meantime, vitamin A status could improve for many in the population. And optimizing vitamin A delivery could improve public health in at-risk populations.

A reasonable objection concerns possible human or environmental health risks. The United Nations (UN) Cartagena Protocol on Biosafety (15) provides a framework for the regulation of genetically engineered crops in many countries, emphasizing the Precautionary Principle in assessing risks, and leaving out assessment of benefits. This Protocol was signed in 2000 and became effective in 2003, in the relatively early days of agricultural genetic engineering. Since then, multiple studies have reported on benefits of genetically modified organism (GMO) adoption through increased yields, reduced pesticide use, improved farmer income, reduced prices to consumers, and in some cases even improved food safety (16). Meanwhile, there have been no confirmed incidents of adverse human health or environmental effects from genetically engineered crops during nearly three decades of global use (16).

Transgenic crops are subject to many required regulatory tests before approval, including animal feeding and invitro studies for toxicity and allergenicity. Yet opponents of these crops have continued to amplify suspicion on the long-term health effects of genetically engineered crops (17). Protection against such risks can be achieved through monitoring of the performance and the impacts of technologies and intervening when setbacks occur. However, the food safety assessments for transgenic crops in many countries are more demanding than for conventionally bred varieties. In fact, often less is known about the properties of plants developed by conventional mutagenesis than those developed by transgenic methods.

Another concern is that GR genes may intermingle with those of conventionally bred rice varieties. This uncertainty, however, applies not just to GR but also to any other new rice variety. Humans have consumed rice for more than 4,000 years, including varieties that have been crossed genetically across multiple strains. Transgenic methods of introducing novel genes is not inherently of greater concern, unless those genes produce proteins with potential adverse health effectssomething that food safety tests for approval can determine. Clearly the lives saved with VAD outweigh concerns about these so-called unknown risks. In response to such criticisms, in 2016 more than 150 Nobel Laureates have signed an open letter to the UN, governments of the world, and Greenpeace, urging a more balanced approach toward genetically modified crops in general and GR in particular: Scientific and regulatory agencies around the world have repeatedly and consistently found crops and foods improved through biotechnology to be as safe as, if not safer than, those derived from any other method of production. Opposition based on emotion and dogma contradicted by data must be stopped (18).

The arguments used by organizations to delay adoption of GR often resemble the arguments of anti-vaccination groups, including those protesting vaccines to protect against COVID-19. Some of the opponents of GR and agricultural biotechnology more generally see the introduction of GR as forcing the consumption of GMOs on the population. However, for the case of GR, consumers have the option of easily avoiding consumption because GR is very easily identifiable by its color.

The tragedy of GR is that regulatory delays of approval have immense costs in terms of preventable deaths, with no apparent benefit (13). The approval of GR is even more urgent with the ongoing pandemic, which has made access to healthcare services more difficult in vulnerable populations worldwide. The World Bank has recommended that micronutrient biofortification of staple crops, including specifically GR, should be the norm and not the exception in crop breeding (19).

Golden rice can effectively control VAD. Delaying the uptake of a genetically modified product shown to have clear health benefits has and will cost numerous lives, frequently of the most vulnerable individuals. Policymakers must find ways to overcome this resistance and accelerate the introduction and adoption of Golden Rice.

Author contributions: J.W., D.Z., and A.D. designed research; F.W., J.W., C.C., and A.D. performed research; F.W., J.W., and C.C. analyzed data; and F.W., J.W., D.Z., R.R., C.C., and A.D. wrote the paper.

Competing interest statement: A.D. is a member and the Executive Secretary of the Golden Rice Humanitarian Board. He is a volunteer, unpaid and without grants. R.R. is a member of the Golden Rice Humanitarian Board. He is a volunteer, unpaid and without grants. The Golden Rice Humanitarian Board (http://www.goldenrice.org) holds the rights for humanitarian applications of the nutritional technology created by Professors Ingo Potrykus and Peter Beyer and related licensed technology. The Board is not legally incorporated in any way. It is a group of individuals who voluntarily share the objective of making Golden Rice available to resource-poor populations as a public good, delivered by the public sector in locally adapted and preferred rice varieties, at no greater cost than white rice and with no use limitations except export. All other authors declare no competing interests.

Any opinions, findings, conclusions, or recommendations expressed in this work are those of the authors and do not necessarily reflect the views of the National Academy of Sciences.

*Many transformation events were produced (8), from which event GR2E has been selected on the basis of molecular structure and insertion in the rice genome, together with agronomic performance. It is the basis of the regulatory data generated and is the only form of GR which is offered for approval and use.

See the rest here:
Opinion: Allow Golden Rice to save lives - pnas.org

President Joe BidenJoe BidenFederal class action lawsuit filed over treatment of Haitian migrants Staffer who had contact with Biden tests positive for COVID-19 Overnight Defense & National Security New rules try to tackle extremism in the ranks MORE recently assembled the leaders of more than 100 democracies worldwide for a virtual Summit for Democracy. Not surprisingly, the gathering drew the ire of China and Russia, whose ambassadors penned a joint op-ed castigating it a vestige of Cold War mentality and calling on countries to stop using "value-based diplomacy" to provoke division and confrontation.

The summit was useful to begin conversations on how to confront the daunting challenges facing the free world. But it is not sufficient. The time has come to establish an Alliance of Democracies that would bring together the United States and its allies in Europe and the Indo-Pacific, and other willing democracies worldwide that share common interests and values and are prepared to act.

As Biden underscored in his introductory remarks, democracy is facing alarming and sustained challenges, including from autocrats, who seek to advance their own power and export and expand their influence around the world.China and Russia, in particular, have become more assertive in challenging key tenets of the rules-based global order, Democracies are on the defensive as they contend with these and other global threats. To succeed in this fundamental struggle between democracy and autocracy, democracies must strengthen cooperation.

An Alliance of Democracies would provide a highly visible platform for fostering solidarity in the face of common threats and challenges. The leading democracies in North America, Europe and the Indo-Pacific make up roughly three-quarters of global gross domestic product. In combination with the European Union, the transatlantic partnership provides nearly 80 percent of official developmental aid worldwide. And the 20 highest scoring countries in terms of soft-power influence are all democracies. These assets provide the United States and its allies with an enormous source of leverage in addressing global challenges.

But the Alliance of Democracies must be more than symbolic. Instead, its members must be prepared to take meaningful action to address the three defining challenges facing the democratic world. The first is the increasing assertiveness by China and Russia to make the world safer from autocracy. Moscow and Beijing are using diplomatic and economic coercion including military threats, cyber operations, malign finance and other wolf warrior diplomacy tactics to pressure smaller governments and global corporations to accommodate their interests.

In response, the alliance could facilitate coordinated sanctions and other measures to deter such behavior, and provide a mechanism to provide joint assistance to targeted democracies. It could also help make democracies less vulnerable to economic coercion, including, for example, by facilitating alternative supply chains for sensitive technologies and critical energy supplies.

The second is backsliding within established democracies. Whether through the acquiescence of their electorate or manipulation of electoral processes, populist leaders in many democracies have been using their authority to undermine democratic norms. The alliance can serve as a mechanism to hold states accountable for their democratic practices at home. Building on the loose pledge system for leaders interventions at the Summit for Democracy, countries could be asked to make specific commitments to advance democratic renewal at home as part of their alliance membership obligations.

The third is the rise of emerging and potentially disruptive technologies. Such technologies including artificial intelligence, quantum computing, genetic engineering and 5G are developing rapidly and will significantly shape the future of geopolitics. While these innovations promise great benefits, they also carry serious risks, including security challenges. If China or other autocratic nations succeed in developing these technologies ahead of the democratic world, they could gain significant economic and military advantages. To counter this, the alliance should set common standards for advanced technologies that are consistent with liberal norms. The goal is to ensure that the democratic world and fundamental values prevail in the technological race.

Support for closer alignments among democracies is building. In hosting the Group of Seven (G7) summit earlier this year, British Prime Minister Boris JohnsonBoris JohnsonQueen cancels British royal family's Christmas gathering: report It's time for an alliance of democracies The Hill's Morning Report - Presented by National Industries for the Blind - Manchin says no; White House fires back MORE sought to advance the idea of a D-10 club of democracies. Lawmakers in Britain and Canada have expressed support for new coalitions of democracies, and the traffic light coalition making up the new government in Germany called for the creation of an Alliance of Democracies in a recent policy paper. In the United States, proposals for closer cooperation among democracies have drawn bipartisan support among lawmakers in Congress.

That China and Russia have spoken out so vehemently about the Summit for Democracy indicates a level of concern as to where this initiative might lead. Nevertheless, it would not serve the interests of the United States or its allies to provoke a new Cold War dynamic that could lead to escalating tensions or even direct confrontation. The reality is, however, that competition between democratic and autocratic powers is now an established feature of the current global system. The key question is how democracies will choose to respond. To minimize the risks of polarization, leading democracies should embrace a two-tracked approach: engaging with Beijing and Moscow though the United Nations, G20, and other venues in areas where cooperation may be feasible, and, at the same time, working through an Alliance of Democracies to uphold shared values and interests.

Bidens call to action with his Summit for Democracy could help propel the idea of an alliance forward. The administrations plan for a follow up summit next December could provide the building block for a sustainable cooperative network of democracies. The administration has rightly framed the current era as a historic inflection point between autocracy and democracy. An Alliance of Democracies would provide a signature initiative that is directly responsive to this challenge one that demonstrates leadership and can help align the democratic world in a common direction for will likely be a multi-decade era of strategic competition.

Ash Jain is director for democratic drder at the Atlantic Council.

Jonas Parello-Plesner is executive director of the Copenhagen-based Alliance of Democracies Foundation.

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It's time for an alliance of democracies | TheHill - The Hill

LOS GATOS, Calif., Dec. 21, 2021 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today that its fully human monoclonal antibody (mAb) cocktail AR-701 is broadly reactive against the Omicron and other COVID-19 (SARS-CoV-2) variants, SARS (Severe Acute Respiratory Syndrome), MERS (Middle East Respiratory Syndrome Coronavirus), and seasonal ('common cold') human coronaviruses.

"Omicron has rendered current COVID-19 vaccines and monoclonal antibodies substantially less effective, and likely future COVID 19 variants will arise that continue this trend" said Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "AR-701 is the result of our successful search for a mAb therapy that is directed against a conserved region of the virus that would be less vulnerable to mutations and new variants such as Omicron. Our laboratory data suggest that AR-701 has the potential to be a future-proof COVID-19 therapy that can protect against SARS-CoV-2, SARS, or MERS pandemics," continued Dr. Truong. "To our knowledge AR-701 is the only COVID-19 therapy that targets two distinct viral mechanisms of action, making it much harder for the virus to generate resistance, and exhibits an unmatched combination of broad reactivity and high efficacy," continued Dr. Truong.

About AR-701AR-701 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 infected (COVID-19) patients. AR-701 consists of AR-703 and AR-720 mAbs, each neutralizes coronaviruses using distinct mechanisms of action, namely inhibition of viral fusion and entry into human cells (AR-703) and blockage of viral binding to the human 'ACE2' receptor (AR-720). The two mAbs complement and enhance each other in a synergistic fashion, creating a potent first-in-class cocktail. AR-703 binds to the 'S2' stalk region of spike proteins from betacoronaviruses, including the SARS-CoV2 variants (beta, gamma, delta, epsilon), and binds to the Omicron variant with no loss in affinity compared to the original Wuhan strain. Multiple animal challenge models widely used to evaluate COVID-19 treatments support AR-701's broad efficacy, including:

The AR-701 mAbs are engineered to be active for 6-12 months in the blood. AR-701 is being developed as a long-acting intramuscular as well as a self-administered inhaled formulation for the treatment of COVID-19 patients who are not yet hospitalized. AR-701 mAbs were discovered through a collaboration with researchers at the University of Alabama in Birmingham and Texas Biomedical Research Institute (San Antonio, TX).

About Aridis Pharmaceuticals, Inc.

Aridis Pharmaceuticals, Inc. discovers and develops novel anti-infective therapies to treat life-threatening infections, including anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary PEXTM and MabIgX technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture monoclonal antibody (mAbs) for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they technically do not require genetic engineering or further optimization to achieve full functionality.

The Company is advancing multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:

Aridis' Pipeline

AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin and is being evaluated in a global Phase 3 clinical study as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP).

AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being developed as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. Phase 3 is expected to be initiated in 2Q22.

AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients. This program is currently in Phase 2a clinical development in CF patients.

AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer. AR-701 replaces AR-712 as the company's leading COVID mAb candidate.

AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.

AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.

AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).

For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2020 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Contact:Media Communications:Matt SheldonRedChip Companies Inc.Matt@redchip.com1.917.280.7329

Investor RelationsDave GentryRedChipDave@redchip.com1-800-733-2447

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SOURCE Aridis Pharmaceuticals, Inc.

Company Codes: NASDAQ-NMS:ARDS

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Aridis Pharmaceuticals Announces a Pan-Coronavirus Monoclonal Antibody Cocktail That Retains Effectiveness Against the Omicron variant, other COVID-19...

Bats sweltering in their boxes, polar bears and narwhals using up to four times as much energy to survive, birds starving as Turkeys lakes dry up, and unique island species at high risk of extinction as the planet warms. If there was ever any doubt about the inextricable link between the climate emergency and the biodiversity crisis, those doubts were well and truly dispelled in 2021.

The science is clear: climate, biodiversity and human health are fully interdependent, Frans Timmermans, the European Commission vice-president who heads the European Green Deal; Achim Steiner, of the UN Development Programme; and Sandrine Dixson-Declve, of the Club of Rome, wrote before the Cop26 climate conference.

While the much-anticipated Cop15 Kunming biodiversity conference was delayed yet again, Cop26 brought together leaders from across the globe to discuss the climate emergency. Although the pledges on emissions cuts fell short of those required to limit the increase in temperatures to 1.5C, there were promises to halt and reverse global deforestation over the next decade.

Meanwhile, dozens of countries have committed to protecting 30% of the planets land and oceans by 2030, and in September, nine philanthropic foundations pledged $5bn (3.75bn) to finance the 30x30 pledge.

Despite the coronavirus pandemic and the many lockdowns, 2021 saw the worlds scientists, volunteers and conservationists continuing their efforts to protect nature. The International Union for Conservation of Nature launched its new green list of protected and conserved areas, researchers at the Natural History Museum worked on digitising its vast collection, Kenya held its first animal census, and a multimillion-pound project was launched that aims to describe and identify the web of life in large freshwater ecosystems with game-changing DNA technology.

In September, the IUCN world conservation congress in Marseille brought together innovators and policymakers from across the world for talks and debates on subjects as diverse as the universal declaration of the rights of the river, alien species, human-wildlife conflict, the use of smart technology in conservation, genetic engineering and much more.

Not all conservation efforts are down to scientists and policymakers though. There is growing recognition of the vital role communities and indigenous people play in conserving biodiversity and building livelihoods and this year we highlighted projects that included a shade-grown coffee initiative in Peru, islanders rallying to save the coco de mer nut in Seychelles and an army of nature recorders and seed conservers in the UK.

There was good news elsewhere. The flatpack homes for animals that fall victim to wildfires that we highlighted in April have since been trialled in Sydney, where a housing estate of the biodegradable cardboard pods has been put up to give shelter to wildlife after the bushfires.

In response to our piece on conservationists criticising Marks & Spencer for releasing 30 million honeybees, the British retailer filled 500 stores with little signs telling shoppers about the importance of native bumblebees in producing a number of foods. M&S has been really open to learning, said Gill Perkins, chief executive of the Bumblebee Conservation Trust, who believes it is the first UK supermarket to introduce bumblebee labels highlighting the work of these pollinators. She hopes others will follow suit.

Andrew Kerr, who spoke to the Guardian about wanting to create a UK eel rewilding programme, is having discussions with the relevant government ministry in January about the feasibility of getting rewilding permits sorted for this coming eel season.

Since we reported on the proposals to extend Barcelona airport, threatening neighbouring wetlands and a wealth of biodiversity, the plans have been put on hold. The future of the red wolf in North Carolina still hangs in the balance but the US Fish and Wildlife Service says it is planning to release nine wolves from captivity this winter. And an experimental feeding programme has been approved for Floridas manatees, after a record year of deaths.

Over the coming weeks, we will follow up on some of the stories that we covered during 2021 in more depth, but in the meantime, you might like to take a look at some of our favourite articles from the year that celebrate the planets beautiful and intricate biodiversity: why we need to stop treating soil like dirt; the wonderful world of fungi; the value of dead wood; how a wild night out could help you reconnect with nature; and, lastly, a lesson in why some things are worth waiting for, especially when they turn out like this

Find more age of extinction coverage here, and follow biodiversity reporters Phoebe Weston and Patrick Greenfield on Twitter for all the latest news and features

Excerpt from:
2021: when the link between the climate and biodiversity crises became clear - The Guardian

A LAB leak from Wuhan is now the "more likely" cause of the Covid pandemic, experts have told British MPs.

Dr Alina Chan, a genetic engineering expert,said she was "very confident" the truth will eventually come out about the origins of the deadly bug.

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The molecular biologist at MIT and Harvard believes a lab leak from the Wuhan Institute of Virology (WIV) is "more likely than not" after two unsuccessful years of searching for an animal host.

The WIV - a high security facility specalising in coronaviruses - has been in the eye of the storm as questions rage over whetherCovidcould have escaped from its lab.

BothChinaand the lab have furiously denied any allegations,but evidence of a lab leak has been piling up over the last year as scientists, researchers and governments hunt for answers.

Dr Chan told the Science and Technology Select Committee: "I think the lab origin is more likely than a natural origin at this point.

"We all agree there was a critical event at the wet market that was a superspreader event - caused by humans. But there is no evidence pointing to a natural animal origin of the virus at that market."

And Dr Chan said she was "very confident" the truth about Covid will eventually emerge in years to come - when it's safe for whistleblowers to step forward.

"We've seen from previous cover-ups that it just takes time, because right now its not safe for people who know about the origin of the pandemic to come forward," she said.

"It might be five years from now, it might be 50 years from now, but we live in an era where there is so much data being collected and stored that it will eventually come out."

Matt Ridley, who co-authored Viral on the origins of the pandemic with Dr Chan, also said a lab leak was now the most likely origin - and urged investigators to find out in order to prevent the next pandemic.

The science writer told MPs: "I also think its more likely than not because we have to face the fact after two months we knew the origins of SARS through markets.

"After a couple of months we knew MERS was though through camels. In this case, after two years, we still haven't found a single infected animal that could be the progenitor of this pandemic, and thats incredibly surprising."

Some scientists have also argued Covid was genetically modified by humans - with one claiming it was "ready made" to infect humans when the virus first emerged in Wuhan.

Dr Chan told MPs: We have heard from many top virologists that a genetically engineered origin of this virus is reasonable - so it's worth investigating - and that includes virologists who made genetic modifications to the first SARS virus.

We know now this virus has a very unique feature, called the furin cleavage site, that makes it the pandemic pathogen it is. So without this feature there is no way this virus would be causing this pandemic.

A proposal was leaked showing that EcoHealth and the Wuhan Institute of Virology were developing a pipeline for inserting novel furin cleavage sites - these genetic modifications.

"So, you fund these scientists who said in early 2018 Im going to put horns on horses and at the end of 2019 a unicorn turns up in Wuhan city.

"It's a striking coincidence that needs to be investigated."

Mr Ridley added: "We need to find out so we can prevent the next pandemic.

"We need to know whether we should be tightening up work in laboratories or whether we should be tightening up regulations related to wildlife markets.

"At the moment we are really not doing either.

We also need to know to deter bad actors who are watching this episode and thinking that unleashing a pandemic is something they could get away with.

We know now that experiments were being done at Biosecurity Level 2 in Wuhan that resulted in 10,000 times increases in infectivity of viruses and three or four times their lethality.

"The important thing is to stop doing these experiments that are risky.

Meanwhile, Richard Horton, The Lancet editor-in-chief, said the lab leak was "a hypothesis that should be taken seriously and needs to be further investigated".

But he told MPs he agreed with the previous conclusions from the World Health Organisation that it was "extremely unlikely".

Dr Chan and Mr Ridley said they both believed the lab leak was an accident - rather than deliberate.

The experts had already warned that terrorists who are considering using bioweapons will have noted how quickly China was able to dismiss the idea of a lab leak - and avoid scrutiny.

It means militants will now know how easily they can "get away" with the release of a cataclysmic bioweapon, knowing the source of the attack will likely never be found.

China has repeatedly stated it is not responsible for the global pandemic and dismissed accusations from those who say the virus was manipulated by humans.

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Excerpt from:
Wuhan lab leak now the most likely cause of Covid pandemic and the truth WILL come out, experts tell MPs... - The US Sun

Though the broad U.S. market saw a tumultuous ride last week with most of the sectors in red, biotechnology was the biggest gainer. This is especially true as the Nasdaq Biotechnology Index jumped 4.9% last week, pushing many ETFs higher.

Virtus LifeSci Biotech Products ETF BBP has been the biggest beneficiary, rising 7.9%. ETFMG Treatments Testing and Advancements ETF GERM, First Trust NYSE Arca Biotechnology Index Fund FBT, ALPS Medical Breakthroughs ETF SBIO and Invesco Dynamic Biotechnology & Genome ETF PBE rose at least 6% last week.

With the rise in Omicron, biotech companies are working on the development of new vaccines and strategies to tackle the spread of the new COVID-19 variant.

According to the latest study, two shots of the Moderna MRNA or Pfizer PFE/BioNTech vaccines or one of Jonson & Johnsons JNJ single-dose vaccine appear to offer significantly less protection against the newly-detected Omicron variant in laboratory testing but a booster dose likely restores most of the protection (read: 5 ETFs That Gained More Than 40% in 2021).

A separate study out of South Africa shows that Pfizers two-dose vaccine provides a high degree of protection against hospitalization from the fast-spreading Omicron. The study concluded that the vaccine offered only 33% protection against overall infection but 70% protection against hospitalization. It also concluded that while there was a higher risk of reinfections during this current surge, the risk of hospitalization among adults was 29% lower than during the initial wave.

Further, the industry trends are impressive. These include new drug nods, an accelerated pace of innovation, promising drug launches, the growing importance of biosimilars, cost-cutting efforts, an aging population, expanding insurance coverage, the rising middle class, an insatiable demand for new drugs and ever-increasing spending on healthcare.

Virtus LifeSci Biotech Products ETF (BBP)

Virtus LifeSci Biotech Products ETF follows the LifeSci Biotechnology Products Index, which measures the performance of biotechnology companies with at least one drug therapy approved by the FDA.

Holding 55 stocks, Virtus LifeSci Biotech Products ETF has accumulated AUM of $18.9 million and charges 79 bps in fees per year. BBP trades in volume of 2,000 shares a day on average and has a Zacks ETF Rank #3 (Hold) with a High-risk outlook.

ETFMG Treatments Testing and Advancements ETF (GERM)

ETFMG Treatments Testing and Advancements ETF offers exposure to biotech companies engaged in the testing and treatments of infectious diseases by tracking the Prime Treatments, Testing and Advancements Index. It is focused on advancements with targeted exposure to the forefront of R&D, vaccines, therapies and testing technologies. ETFMG Treatments Testing and Advancements ETF holds 86 stocks in its basket and charges 68 bps in annual fees (read: 5 Best Sector ETFs of November).

ETFMG Treatments Testing and Advancements ETF has amassed $51.1 million in its asset base and trades in an average daily volume of 14,000 shares.

First Trust NYSE Arca Biotechnology Index Fund (FBT)

First Trust NYSE Arca Biotechnology Index Fund follows the NYSE Arca Biotechnology Index, which measures the performance of companies in the biotechnology industry that are primarily involved in the use of biological processes to develop products or provide services. It holds about 30 securities in its basket and charges 55 bps in annual fees.

First Trust NYSE Arca Biotechnology Index Fund has accumulated $1.7 billion in its asset base and trades in a moderate volume of more than 43,000 shares a day. FBT has a Zacks ETF Rank #3 with a High-risk outlook.

ALPS Medical Breakthroughs ETF (SBIO)

ALPS Medical Breakthroughs ETF provides exposure to companies with one or more drugs in phase II or phase III FDA clinical trials by tracking S-Network Medical Breakthroughs Index. It holds 127 securities in its basket (read: 5 Top-Ranked ETFs to Buy At Bargain Prices).

ALPS Medical Breakthroughs ETF charges 50 bps in fees per year from its investors and trades in a moderate average daily volume of about 18,000 shares. It has AUM of $179.8 million in its asset base and carries a Zacks ETF Rank #3 with a High-risk outlook

Invesco Dynamic Biotechnology & Genome ETF (PBE)

Invesco Dynamic Biotechnology & Genome ETF follows the Dynamic Biotech & Genome Intellidex Index and provides exposure to companies engaged in the research, development, manufacture, and marketing and distribution of various biotechnological products, services and processes and companies that benefit significantly from scientific and technological advances in biotechnology and genetic engineering and research.

Invesco Dynamic Biotechnology & Genome ETF holds 31 stocks in its basket. The product has managed $272.8 million in its asset base and charges 59 bps in annual fees. Invesco Dynamic Biotechnology & Genome ETF has a Zacks ETF Rank #3 with a High-risk outlook.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportJohnson & Johnson (JNJ) : Free Stock Analysis ReportPfizer Inc. (PFE) : Free Stock Analysis ReportModerna, Inc. (MRNA) : Free Stock Analysis ReportFirst Trust NYSE Arca Biotechnology ETF (FBT): ETF Research ReportsInvesco Dynamic Biotechnology & Genome ETF (PBE): ETF Research ReportsALPS Medical Breakthroughs ETF (SBIO): ETF Research ReportsVirtus LifeSci Biotech Products ETF (BBP): ETF Research ReportsETFMG Treatments, Testing and Advancements ETF (GERM): ETF Research ReportsTo read this article on Zacks.com click here.Zacks Investment Research

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Biotech ETFs That Outperformed Last Week - Yahoo Finance

The immune system fights germs and foreign substances on the skin, in the tissues of the body and in bodily fluids such as blood. The immune system is made up of two parts: the innate, (general) immune system and the adaptive (specialized) immune system. These two systems work closely together and take on different tasks.

The innate immune system is the body's first line of defense against germs entering the body. It responds in the same way to all germs and foreign substances, which is why it is sometimes referred to as the "nonspecific" immune system. It acts very quickly: For instance, it makes sure that bacteria that have entered the skin through a small wound are detected and destroyed on the spot within a few hours. The innate immune system has only limited power to stop germs from spreading, though.

The innate immune system consists of

All outer and inner surfaces of the human body a key part of the innate immune system. The closed surface of the skin and of all mucous membranes already forms a physical barrier against germs, which protects them from entering. Additionally, chemical substances like acid, enzymes or mucus prevent bacteria and viruses from gaining a foothold. Movements created, for example, by hair-like structures in the bronchi (cilia) or bowel muscles stop germs from settling in the body. Tear fluid, sweat and urine (which flushes the organs of the urinary tract) have a similar effect.

The innate immune system activates special immune system cells and proteins if germs get past the skin and mucous membranes and enter the body.

When a part of the skin is infected, immune system cells move to the area or immune system cells that are already there are activated. Specific immune system cells release substances into the immediate area that make the blood vessels wider and more permeable. This causes the area around the infection to swell, heat up and redden, and inflammation results. A fever may develop as well. Then the blood vessels expand further and even more immune system cells arrive.

Certain proteins (enzymes) are also activated to help in the immune response (see below).

Bacteria or viruses that enter the body can be stopped right away by scavenger cells (phagocytes). Scavenger cells are special kinds of white blood cells (leukocytes). These cells enclose germs and "digest" them. The remains of these germs move to the surface of the scavenger cells to be detected by the adaptive immune system.

There are also other types of immune system cells that release substances to kill bacteria and various germs. Both germs and body tissue and immune system cells die and decay during an immune system response. Their remains form pus, a yellowish fluid.

Several proteins (enzymes) help the cells of the innate immune system. A total of nine different enzymes activate one another in a process similar to a chain reaction: One enzyme in the first stage alerts several enzymes of the second stage, each of which again activates several enzymes of the third stage, and so on. This allows immune system responses to escalate very quickly.

The tasks of these enzymes include:

marking germs as targets for scavenger cells,

attracting other immune system cells from the bloodstream,

fighting viruses by destroying the viral envelope (the outermost layer of a virus) or cells that have been infected with viruses.

The natural killer cells are the third major part of the innate immune system. They specialize in identifying cells that are infected by a virus or that have become tumorous. To do this, they search for cells that have changes in their surface, and then destroy the cell surface using cell toxins.

The adaptive immune system takes over if the innate immune system is not able to destroy the germs. It specifically targets the type of germ that is causing the infection. But to do that it first needs to identify the germ. This means that it is slower to respond than the innate immune system, but when it does it is more accurate. It also has the advantage of being able to "remember" germs, so the next time a known germ is encountered, the adaptive immune system can respond faster.

This memory is also the reason why there are some illnesses you can only get once in your life, because afterwards your body becomes immune. It may take a few days for the adaptive immune system to respond the first time it comes into contact with the germ, but the next time the body can react immediately. The second infection is then usually not even noticed, or is at least milder.

The adaptive immune system is made up of:

T lymphocytes in the tissue between the body's cells

B lymphocytes, also found in the tissue between the body's cells

Antibodies in the blood and other bodily fluids

T lymphocytes (also called T cells) are produced in bone marrow and then move to the thymus through the bloodstream, where they mature. The "T" in their name comes from "thymus."

T cells have three main jobs:

They use chemical messengers to activate other immune system cells in order to start the adaptive immune system (T helper cells).

They detect cells infected by viruses or tumorous cells and destroy them (cytotoxic T cells).

Some T helper cells become memory T cells after the infection has been defeated. They can "remember" which germs were defeated and are then ready to activate the adapted immune system quickly if there is another infection.

T cells have detection features on their surfaces that can attach to germs like a lock that one particular key will fit. The immune system can produce a matching T cell type for each germ in an infection within a few days.

Then if a germ attaches to a matching T cell, the T cell starts to multiply creating more T cells specialized to that germ. Because only the cells that match the germ multiply, the immune response is customized.

B lymphocytes (B cells) are made in the bone marrow and then mature there to become specialized immune system cells. They take their name from the "B" in "bone marrow." Like the T cells, there are many different types of B cells that match particular germs.

The B cells are activated by the T helper cells: T helper cells contact B cells that match the same germs that they do. This activates the B cells to multiply and to transform themselves into plasma cells. These plasma cells quickly produce very large amounts of antibodies and release them into the blood. Because only the B cells that match the attacking germs are activated, only the exact antibodies that are needed will be produced.

Some of the activated B cells transform into memory cells and become part of the "memory" of the adaptive immune system.

The various cells of the adaptive immune system communicate either directly or via soluble chemical messengers such as cytokines (small proteins). These chemical messengers are mostly proteins and are produced by different cells in the body.

Antibodies are compounds of protein and sugar that circulate in the bloodstream. They are created by the immune system to fight germs and foreign substances. Antibodies can quickly detect germs and other potentially harmful substances, and then attach to them. This neutralizes the "intruders" and attracts other immune system cells to help. Antibodies are produced by the B lymphocytes. Germs and other substances that can provoke the creation of antibodies are also referred to as "antigens."

An antibody only attaches to an antigen if it matches exactly, like a key in the lock of the antibody. That is how antibodies detect the matching germs to initiate a fast response from the adaptive immune system.

Antibodies have three main functions:

They activate other immune system cells by attaching to their surfaces. Scavenger cells are better able to fight off germs that are loaded with antibodies, too.

They activate proteins that help in the immune system response.

The antibodies of the adaptive immune system also support the innate immune system.

Brandes R, Lang F, Schmidt R (Ed). Physiologie des Menschen: mit Pathophysiologie. Berlin: Springer; 2019.

Menche N (Ed). Biologie Anatomie Physiologie. Mnchen: Urban und Fischer; 2016.

Pschyrembel. Klinisches Wrterbuch. Berlin: De Gruyter; 2017.

IQWiG health information is written with the aim of helpingpeople understand the advantages and disadvantages of the main treatment options and healthcare services.

Because IQWiG is a German institute, some of the information provided here is specific to theGerman health care system. The suitability of any of the described options in an individualcase can be determined by talking to a doctor. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by ateam ofhealth care professionals, scientists and editors, and reviewed by external experts. You canfind a detailed description of how our health information is produced and updated inour methods.

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The innate and adaptive immune systems - InformedHealth ...

The immune system has a vital role: It protects your body from harmful substances, germs and cell changes that could make you ill. It is made up of various organs, cells and proteins.

As long as your immune system is running smoothly, you dont notice that its there. But if it stops working properly because its weak or can't fight particularly aggressive germs you get ill. Germs that your body has never encountered before are also likely to make you ill. Some germs will only make you ill the first time you come into contact with them. These include childhood diseases like chickenpox.

Without an immune system, we would have no way to fight harmful things that enter our body from the outside or harmful changes that occur inside our body. The main tasks of the bodys immune system are

to recognize and neutralize harmful substances from the environment, and

to fight disease-causing changes in the body, such as cancer cells.

The immune system can be activated by a lot of different things that the body doesnt recognize as its own. These are called antigens. Examples of antigens include the proteins on the surfaces of bacteria, fungi and viruses. When these antigens attach to special receptors on the immune cells (immune system cells), a whole series of processes are triggered in the body. Once the body has come into contact with a disease-causing germ for the first time, it usually stores information about the germ and how to fight it. Then, if it comes into contact with the germ again, it recognizes the germ straight away and can start fighting it faster.

The bodys own cells have proteins on their surface, too. But those proteins dont usually trigger the immune system to fight the cells. Sometimes the immune system mistakenly thinks that the body's own cells are foreign cells. It then attacks healthy, harmless cells in the body. This is known as an autoimmune response.

There are two subsystems within the immune system, known as the innate (non-specific) immune system and the adaptive (specific) immune system. Both of these subsystems are closely linked and work together whenever a germ or harmful substance triggers an immune response.

The innate immune system provides a general defense against harmful germs and substances, so its also called the non-specific immune system. It mostly fights using immune cells such as natural killer cells and phagocytes (eating cells). The main job of the innate immune system is to fight harmful substances and germs that enter the body, for instance through the skin or digestive system.

The adaptive (specific) immune system makes antibodies and uses them to specifically fight certain germs that the body has previously come into contact with. This is also known as an acquired (learned) or specific immune response.

Because the adaptive immune system is constantly learning and adapting, the body can also fight bacteria or viruses that change over time.

Brandes R, Lang F, Schmidt R (Ed). Physiologie des Menschen: mit Pathophysiologie. Berlin: Springer; 2019.

Menche N (Ed). Biologie Anatomie Physiologie. Mnchen: Urban und Fischer; 2016.

Pschyrembel. Klinisches Wrterbuch. Berlin: De Gruyter; 2017.

IQWiG health information is written with the aim of helpingpeople understand the advantages and disadvantages of the main treatment options and healthcare services.

Because IQWiG is a German institute, some of the information provided here is specific to theGerman health care system. The suitability of any of the described options in an individualcase can be determined by talking to a doctor. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by ateam ofhealth care professionals, scientists and editors, and reviewed by external experts. You canfind a detailed description of how our health information is produced and updated inour methods.

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How does the immune system work? - InformedHealth.org ...

Scientists work daily on altering current vaccines by using molecular means to assure the individual that each variant is covered. And there is development of new medications to treat patients who have been infected and are ill.

Published on December 20, 2021

We are going to have to deal with an invasive virus for the foreseeable future. Never has the worlds population been so acutely aware of a deadly non-living particle that wreaks havoc on the worlds people on a weekly basis. Its a force to separate those who are immunologically protected from those who are not. Furthermore, the immune system, which I call the biological soul, determines who is to live or die.

I had been talking about biological warfare to emergency volunteers long before the terrorist attacks of 9/11. Now, the pandemic has brought the biowarfare issue to reality and made it a terrorist act more deadly than 9/11, from an invisible source. Now, we talk about viral replication and immunogenetics to explain the value of vaccination, appropriate behavior and the use of personal protective equipment in 2021. It seems like the COVID virus is living, because it appears when we least expect it in new forms, highly developed and often with new characteristics. It is as though it is alive and directs itself and us. The alpha, the delta and then a plethora of Greek lettered variants, until the recent appearance of Omicron.

There is no doubt that our immune systems are primed to deal with scourges like COVID. The immune system is our biological soul because it directs and protects every organ of the body like a spirit and is present to make sure that you live a long and secure life. The immune system is imperceptibly learning about new invaders every hour of the day in a kind of terrorist drill. It learns and is informed by your microbiomes (bowel, skin, lungs and others), collections of organisms without which the immune system would not work. From your birth, the biomes initially delivered to you by your mother during your voyage into the world to the present biomes determined by your hygiene, diet, stress and consumption of medicines. The immune system learns during every moment of the day by exposure to this or that minor or major antigen. Occasionally with something like the novel coronavirus, the immune system encounters a cunning foe that establishes a resistant presence to an immune system overwhelmed by its lack of recognition of the new invader. You can hear the T cells say, this is not a drill. Moreover, there is always the danger that a new resistance may develop as soon as the immune system learns its way. COVID is discreet in its passage to various organs and does its damage through inflammation in many organs, selective residence in areas like the human brain and the formation of small micro blood clots in the microscopic vessels that line the alveoli of the lung, those little sacks that provide exchange of oxygen. This is the way this efficient particle replicates and, in the process, kills its host.

As with every other kind of invasion by bacteria or parasites, the immune system can inform itself and overcome most infections. It all depends on the health of your biological soul, your genetic predisposition and the number of organ comorbidities like heart disease, lung disease, obesity or simply age. After infection, the response among humans who have recovered as measured by neutralizing antibody, or in rare cases measured cellular immunity, varies from individual to individual. As I looked for strong titered antibodies from the previously infected survivors to get some convalescent sera for use among the dying, I was struck by the inconsistency of the immune response in most patients who recovered from COVID. This was clearly proof that the immune response was different for all of us. Vaccination is needed for both the previously infected and those who wish to prevent initial infection, and both responses vary from individual to individual.

I am astonished by misinformation about the vaccine and its efficacy (largely the result of ignorance), but more importantly, I am stunned by the disinformation given by certain individuals (purposeful attempts at obfuscation) and groups on social media decrying the need for the jab. This disinformation has effects are on both young and old folks and is the basis for vaccine hesitancy and doubtless thousands of deaths. Excuses have abounded, such as the vaccine does not work because it has been rushed, it affects fertility, it is really a chip that is injected into you to follow you, it is given to old people to eliminate them from the population or finally that the virus is a political hoax. Since there have now been over 800,000 deaths in this country alone and only 61 percent of the population is vaccinated (the lowest among wealthy countries), this disinformation is very deadly. Because of vaccine hesitancy, families are fractured. The unvaccinated are prohibited from interacting with relatives over the holidays. Extra attention is given by hosts and hostesses to ensure that there are no super spreaders amongst them. A recent wedding of a cousin that resulted in 35 infected people with two guests hospitalized is a stark example of what can happen.

Naming this the year of immunity is a perfect substrate for many articles directed to each component of the healthy immune system. Topics such as the long-haul syndrome, breakthrough infections, the new appearance of autoimmunity in those after infection, the sudden appearance of new pain syndromes, the role of the brain and the importance of the biome are all items for future discussion. Moreover, scientists work daily on altering current vaccines by using molecular means to assure the individual that each variant is covered. And there is development of new medications to treat patients who have been infected and are ill. These medications are anti-viral in different ways: One is a nucleoside analogue which disrupts replication of the virus (Molnupiravir), and the other is an anti-viral proteinase inhibitor that acts like anti-HIV and Hepatitis C pills (Paxlovid). Both oral pills should be available in 2022 to prevent further death. While there is no substitute for the vaccine, there is hope for the hesitant.

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New Year: 2022 as the Year of Immunity - Worth