StemCell Therapy

There are many ways in which human stem cells can be used in research and the clinic. Studies of human embryonic stem cells will yield information about the complex events that occur during human development. A primary goal of this work is to identify how undifferentiated stem cells become the differentiated cells that form the tissues and organs. Scientists know that turning genes on and off is central to this process. Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation. A more complete understanding of the genetic and molecular controls of these processes may yield information about how such diseases arise and suggest new strategies for therapy. Predictably controlling cell proliferation and differentiation requires additional basic research on the molecular and genetic signals that regulate cell division and specialization. While recent developments with iPS cells suggest some of the specific factors that may be involved, techniques must be devised to introduce these factors safely into the cells and control the processes that are induced by these factors.

Human stem cells are currently being used to test new drugs. New medications are tested for safety on differentiated cells generated from human pluripotent cell lines. Other kinds of cell lines have a long history of being used in this way. Cancer cell lines, for example, are used to screen potential anti-tumor drugs. The availability of pluripotent stem cells would allow drug testing in a wider range of cell types. However, to screen drugs effectively, the conditions must be identical when comparing different drugs. Therefore, scientists must be able to precisely control the differentiation of stem cells into the specific cell type on which drugs will be tested. For some cell types and tissues, current knowledge of the signals controlling differentiation falls short of being able to mimic these conditions precisely to generate pure populations of differentiated cells for each drug being tested.

Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies. Today, donated organs and tissues are often used to replace ailing or destroyed tissue, but the need for transplantable tissues and organs far outweighs the available supply. Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases including maculardegeneration, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.

Figure 3. Strategies to repair heart muscle with adult stem cells. Click here for larger image.

2008 Terese Winslow

For example, it may become possible to generate healthy heart muscle cells in the laboratory and then transplant those cells into patients with chronic heart disease. Preliminary research in mice and other animals indicates that bone marrow stromal cells, transplanted into a damaged heart, can have beneficial effects. Whether these cells can generate heart muscle cells or stimulate the growth of new blood vessels that repopulate the heart tissue, or help via some other mechanism is actively under investigation. For example, injected cells may accomplish repair by secreting growth factors, rather than actually incorporating into the heart. Promising results from animal studies have served as the basis for a small number of exploratory studies in humans (for discussion, see call-out box, "Can Stem Cells Mend a Broken Heart?"). Other recent studies in cell culture systems indicate that it may be possible to direct the differentiation of embryonic stem cells or adult bone marrow cells into heart muscle cells (Figure 3).

Cardiovascular disease (CVD), which includes hypertension, coronary heart disease, stroke, and congestive heart failure, has ranked as the number one cause of death in the United States every year since 1900 except 1918, when the nation struggled with an influenza epidemic. Nearly 2,600 Americans die of CVD each day, roughly one person every 34 seconds. Given the aging of the population and the relatively dramatic recent increases in the prevalence of cardiovascular risk factors such as obesity and type 2 diabetes, CVD will be a significant health concern well into the 21st century.

Cardiovascular disease can deprive heart tissue of oxygen, thereby killing cardiac muscle cells (cardiomyocytes). This loss triggers a cascade of detrimental events, including formation of scar tissue, an overload of blood flow and pressure capacity, the overstretching of viable cardiac cells attempting to sustain cardiac output, leading to heart failure, and eventual death. Restoring damaged heart muscle tissue, through repair or regeneration, is therefore a potentially new strategy to treat heart failure.

The use of embryonic and adult-derived stem cells for cardiac repair is an active area of research. A number of stem cell types, including embryonic stem (ES) cells, cardiac stem cells that naturally reside within the heart, myoblasts (muscle stem cells), adult bone marrow-derived cells including mesenchymal cells (bone marrow-derived cells that give rise to tissues such as muscle, bone, tendons, ligaments, and adipose tissue), endothelial progenitor cells (cells that give rise to the endothelium, the interior lining of blood vessels), and umbilical cord blood cells, have been investigated as possible sources for regenerating damaged heart tissue. All have been explored in mouse or rat models, and some have been tested in larger animal models, such as pigs.

A few small studies have also been carried out in humans, usually in patients who are undergoing open-heart surgery. Several of these have demonstrated that stem cells that are injected into the circulation or directly into the injured heart tissue appear to improve cardiac function and/or induce the formation of new capillaries. The mechanism for this repair remains controversial, and the stem cells likely regenerate heart tissue through several pathways. However, the stem cell populations that have been tested in these experiments vary widely, as do the conditions of their purification and application. Although much more research is needed to assess the safety and improve the efficacy of this approach, these preliminary clinical experiments show how stem cells may one day be used to repair damaged heart tissue, thereby reducing the burden of cardiovascular disease.

In people who suffer from type1 diabetes, the cells of the pancreas that normally produce insulin are destroyed by the patient's own immune system. New studies indicate that it may be possible to direct the differentiation of human embryonic stem cells in cell culture to form insulin-producing cells that eventually could be used in transplantation therapy for persons with diabetes.

To realize the promise of novel cell-based therapies for such pervasive and debilitating diseases, scientists must be able to manipulate stem cells so that they possess the necessary characteristics for successful differentiation, transplantation, and engraftment. The following is a list of steps in successful cell-based treatments that scientists will have to learn to control to bring such treatments to the clinic. To be useful for transplant purposes, stem cells must be reproducibly made to:

Also, to avoid the problem of immune rejection, scientists are experimenting with different research strategies to generate tissues that will not be rejected.

To summarize, stem cells offer exciting promise for future therapies, but significant technical hurdles remain that will only be overcome through years of intensive research.

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Cancer immunotherapy drugs, which spur the bodys own immune system to attack tumors, hold great promise but still fail many patients. New research may help explain why some cancers elude the new class of therapies, and offer some clues to a solution.

The study, published on Thursday in the journal Cell, focuses on colorectal and prostate cancer. These are among the cancers that seem largely impervious to a key mechanism of immunotherapy drugs.

The drugs block a signal that tumors send to stymie the immune system. That signal gets sent via a particular molecule that is found on the surface of some tumor cells.

The trouble is that the molecule, called PD-L1, does not appear on the surface of all tumors, and in those cases, the drugs have trouble interfering with the signal sent by the cancer.

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The new study is part of a growing body of research that suggests that even when tumors dont have this PD-L1 molecule on their surfaces, they are still using the molecule to trick the immune system.

Instead of appearing on the surface, the molecule is released by the tumor into the body, where it travels to immune system hubs, the lymph nodes, and tricks the cells that congregate there.

They inhibit the activation of immune cells remotely, said Dr. Robert Blelloch, associate chairman of the department of urology at the University of California, San Francisco, and a senior author of the new paper.

The U.C.S.F. scientists discovered that they could cure a mouse of prostate cancer if they removed the PD-L1 that was leaving the tumor and traveling to the lymph nodes to trick the immune system. When that happened, the immune system attacked the cancer effectively.

Furthermore, the immune system of the same mouse seemed able to attack a tumor later even when the drifting PD-L1 was reintroduced. This suggested to Dr. Blelloch that it might be possible to train the immune system to recognize a tumor much the way a vaccine can train an immune system to recognize a virus.

The work was done not in humans but in laboratory experiments and in mice, and it is not clear whether the results will translate in people. Dr. Ira Mellman, vice president of cancer immunology at Genentech, called the findings a most interesting result.

But as with all mouse experiments, you get insight into basic mechanisms, but how it translates to the human therapeutic setting is unclear, said Dr. Mellman. He is skeptical, he said, but plans to meet shortly with Dr. Blelloch to discuss the implications of the work.

The new research dovetails with other recent studies, including a paper published last year in the journal Nature that showed that PD-L1 molecules released from skin cancer tumors can suppress the bodys immune function.

When these bits of PD-L1 travel outside the cell, they are known as exosomal, and the discovery of their role is one of many fast-moving developments refining an area of medicine that has become among the most promising in decades.

Late last year, the Nobel Prize was awarded to two scientists James P. Allison of the M.D. Anderson Cancer Center in Houston, and Tasuku Honjo of Kyoto University in Japan who did groundbreaking work in immunotherapy.

An explosion of additional research is aimed not only at refining the therapies which can have profound side effects but also at searching for other molecules involved in the perilous dance between cancer and the immune system.

Far more study is needed. But Dr. Blelloch said the findings have him looking for ways to take the next steps into turning the discovery into a concrete therapy.

Interfering with the PD-L1 traveling to lymph nodes can lead to a long-lasting, systemic, anti-tumor immunity, the paper concluded.

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Integrative medicine: Alternative becomes mainstream

What's considered an alternative therapy is a moving target. Learn the lingo and get the facts.

Complementary medicine has never been more popular. Nearly 30 percent of adults report using complementary and alternative medicine (CAM). Doctors are embracing CAM therapies, too, often combining them with mainstream medical therapies spawning the term "integrative medicine."

Exactly what's considered complementary medicine changes constantly as treatments undergo testing and move into the mainstream. To make sense of the many therapies available, it helps to look at how they're classified by the National Center for Complementary and Integrative Health (NCCIH):

Examples include dietary supplements and herbal remedies. These treatments use ingredients found in nature. Examples of herbs include ginseng, ginkgo and echinacea; examples of dietary supplements include selenium, glucosamine sulfate and SAMe. Herbs and supplements can be taken as teas, oils, syrups, powders, tablets or capsules.

Mind-body techniques strengthen the communication between your mind and your body. CAM practitioners say these two systems must be in harmony for you to stay healthy. Examples of mind-body connection techniques include meditation, prayer, relaxation and art therapies.

Manipulation and body-based practices use human touch to move or manipulate a specific part of your body. They include chiropractic and osteopathic manipulation and massage.

Some CAM practitioners believe an invisible energy force flows through your body, and when this energy flow is blocked or unbalanced, you can become sick. Different traditions call this energy by different names, such as chi, prana and life force. The goal of these therapies is to unblock or re-balance your energy force. Energy therapies include qi gong, healing touch and reiki.

There are other approaches to complementary health that focus on a system, rather than just a single practice or remedy, such as massage. These systems center on a philosophy, such as the power of nature or the presence of energy in your body. Examples of these approaches include:

Many conventional doctors practicing today didn't receive training in CAM or integrative medicine, so they may not feel comfortable making recommendations or addressing questions in this area.

Doctors also have good reason to be cautious when it comes to some CAM. Conventional medicine values therapies that have been demonstrated through research and testing to be safe and effective. While scientific evidence exists for some CAM therapies, for many there are key questions that are yet to be answered.

In addition, some CAM practitioners make exaggerated claims about curing diseases, and some ask you to forgo treatment from your conventional doctor. For these reasons, many doctors are cautious about recommending these therapies.

One reason for the lack of research in alternative treatments is that large, carefully controlled medical studies are costly. Trials for conventional therapies are often funded by big companies that develop and sell drugs. Fewer resources are available to support trials of CAM therapies. That's why NCCIH was established to foster research into CAM and make the findings available to the public.

Work with your conventional medical doctor to help you make informed decisions regarding CAM treatments. Even if your doctor can't recommend a specific practitioner, he or she can help you understand possible risks and benefits before you try a treatment.

It's especially important to involve your doctor if you are pregnant, have medical problems or take prescription medicine. And don't stop or change your conventional treatment such as the dose of your prescription medications without talking to your doctor first. Finally, be sure to keep your doctor updated on any alternative therapies you're using, including herbal and dietary supplements.

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QUESTION: What are the benefits of human genetic engineering?

ANSWER:

The benefits of human genetic engineering can be found in the headlines nearly every day. With the successful cloning of mammals and the completion of the Human Genome Project, scientists all over the world are aggressively researching the many different facets of human genetic engineering. These continuing breakthroughs have allowed science to more deeply understand DNA and its role in medicine, pharmacology, reproductive technology, and countless other fields.

The most promising benefit of human genetic engineering is gene therapy. Gene therapy is the medical treatment of a disease by repairing or replacing defective genes or introducing therapeutic genes to fight the disease. Over the past ten years, certain autoimmune diseases and heart disease have been treated with gene therapy. Many diseases, such as Huntington's disease, ALS (Lou Gehrig's disease), and cystic fibrosis are caused by a defective gene. The hope is that soon, through genetic engineering, a cure can be found for these diseases by either inserting a corrected gene, modifying the defective gene, or even performing genetic surgery. Eventually the hope is to completely eliminate certain genetic diseases as well as treat non-genetic diseases with an appropriate gene therapy.

Currently, many pregnant women elect to have their fetuses screened for genetic defects. The results of these screenings can allow the parents and their physician to prepare for the arrival of a child who may have special needs before, during, and after delivery. One possible future benefit of human genetic engineering is that, with gene therapy, a fetus w/ a genetic defect could be treated and even cured before it is born. There is also current research into gene therapy for embryos before they are implanted into the mother through in-vitro fertilization.

Another benefit of genetic engineering is the creation pharmaceutical products that are superior to their predecessors. These new pharmaceuticals are created through cloning certain genes. Currently on the market are bio-engineered insulin (which was previously obtained from sheep or cows) and human growth hormone (which in the past was obtained from cadavers) as well as bio-engineered hormones and blood clotting factors. The hope in the future is to be able to create plants or fruits that contain a certain drug by manipulating their genes in the laboratory.

The field of human genetic engineering is growing and changing at a tremendous pace. With these changes come several benefits and risks. These benefits and risks must be weighed in light of their moral, spiritual, legal, and ethical perspectives. The potential power of human genetic engineering comes with great responsibility.

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There are several genes known as longevity genes that increase your odds of becoming a centenarian. Specific variants of these genes are associated with an increased likelihood of living to be 100 or more. And more importantly, these genetic variants are linked to longer healthspan.

What are the odds of living to 100?Someoneborn a hundred years ago has less than 1% chance of being alive today. If you are female and born in 1973, your odds of living to 100 are 20%. Wondering about the odds for your birth year? Here is a nice chart of your odds of living to 100 based on your birth year:http://discovertheodds.com/what-are-the-odds-of-living-to-100/

So if your odds of living to 100 are 20%, a gene that increases that by 1.5x or 2xis actually significant.Keep in mind, though, that while genetics does play a role in how long you live, there are other health and lifestyle factors that are also important. This is all about statistics here.

FOXO3A gene:

The FOXO3A gene (forkhead box O3) has been linked to longevity in several different studies. This gene is believed to regulate apoptosis, which is necessary for cell death, and is a tumor suppressor. One study describes it thus FOXO proteins have been involved in the regulation of response to oxidative stress, starvation and caloric restriction with the final effect of increasing lifespan and prevent aging-related diseases, such as diabetes and cancer[ref]For the SNP rs2802292, the G allele was found to be an indicator of longevity. The odds ratio of living longer for G/G vs. T/T was found to be 2.75 in a study of Japanese males. Another study of Italians found that a proxy of the SNP above is associated with a 1.5x increase in odds of longevity.

CETP Gene:Another gene related to longevity is the CETP gene (cholesteryl ester transfer protein) which is involved in exchanging triglycerides with cholesteryl esters. One polymorphism that is related to longevity is rs5882 (also referred to as I405V). The G allele is associated with a somewhat longer lifespan. Heterozygotes (A/G) and homozygotes (G/G) are more likely to have a longer lifespan and have higher HDL cholesterol. Homozygotes (G/G) also have a .28x lower risk of dementia and a .31x lower risk of Alzheimers! [study]

Check your 23andMe results for rs5882 (V.4, v.5):

IGF1R gene:The IGF1R gene codes for the insulin-like growth factor 1 receptor. IGF1 is a hormone that signals for growth and anabolic activities. Growth hormone levels generally fall as we age.

Carrying the genes that increase my chance of living to 100 has changed my attitude and way of thinking about getting older. First, planning for retirement is important! But even more on my mind is that the things that I do now to optimize my health will pay off in the long run with a longer healthspan. Prevention of Alzheimers Disease and optimizing my Circadian Rhythmare top on my list of lifehacks this year.

The OkinawanDiet is thought to promote healthy longevity in part through affecting FOXO3. The diet focuses on fresh vegetables, fish, lean meats, omega-3 fats, and unrefined carbohydrates.

Green tea polyphenols (EGC/G) have been found to increase FOXO3 levels.

Astaxanthin, naturally found in shrimp, salmon, and red algae, has been found to increase FOXO3 levels.[ref] If you arent getting enough astaxanthin from your diet, you can get it as a supplement.

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Biotechnology Career Overview

If biology is your bag, you may be interested in biotech careers. Biological technicians often work at universities or in commercial labs assisting with experiments and tests. Biochemists, biophysicists and microbiologists are biotech jobs worked in universities or commercial or private offices and labs studying organisms, microorganisms, biological development and growth.

If you're looking at biotechnology careers, be prepared to get an education. Technicians and microbiologists need at least a bachelor's degree in biology, microbiology or a related field. Biochemists and biophysicists need a doctoral degree to find employment doing independent research and even development. Occasionally, you may find an entry-level biotech job that only requires a bachelor's or master's degree, but you'll want to go on to complete your Ph.D. if you aspire to move up the biotechnology ladder.

Overall, biotech careers are expected to increase in demand over the next 10 years. The Bureau of Labor Statistics (BLS) projects a 10 percent growth for biological techs, biochemists and biophysicists between 2012 and 2022, and a seven percent increase in microbiologists' jobs. Increased demand for research in the biotechnology field and the aging baby boomer population are the key issues that the BLS names for the positive job market outlook in these fields. That's good news for biochemists, biophysicists and microbiologists, as they held roughly only 49,300 jobs in 2012. The biotech techs, however, were almost double the other three biotech careers combined, expected to be around 88,300 by 2022, up from 80,200 jobs in 2012.

As with any job that requires a degree, biotech positions command higher salaries. Techs are the low men on the totem pole with an average annual salary of $38,750. If you put the time and effort into earning a master's degree or a Ph.D. for one of the other biotech jobs, however, the pay increases. Microbiologists earn an annual median wage of $66,260 and biochemists and biophysicists bring in even more with average annual pay at $81,480.

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Stem cell therapies have come a long way since the 1970s and 1980s. Today the ethical issues of harvesting stem cells have long been resolved through the discovery of several sources of potent stem cell types. Common sources include in the umbilical cord and placenta (post birth), bone marrow, and the fatty layer that lies just beneath everyones skin (adipose fat tissue). Of these resources, by far the most commonly accessed in the United States are adipose fat and bone marrow stem cells.The National Stem Cell Institute (NSI), a leading stem cell clinic in the U.S., has seen the development of these living resources usher in an exciting new age known as regenerative medicine. Because of their potency and new technologies that allow ease of access, stem cells are changing the very face of medicine. In particular, the harvesting of bone marrow stem cells has developed into a procedure that is minimally invasive, far more comfortable than bone marrow harvesting of the past, and able to be complete in just a few hours.Some Basics About Bone Marrow Stem CellsBone marrow is the living tissue found in the center of our bones. Marrow is a soft, sponge-like tissue. There are two types of bone marrow: red marrow and yellow marrow. In adults, red marrow is found mainly in the central skeleton, such as the pelvis, sternum, cranium, ribs, vertebrae, and scapulae. But it is also found in the ends of long bones such as in the arms and legs.When it comes to bone marrow stem cells, red marrow is what its all about. Red marrow holds an abundance of them. Stem cells are a kind of protocell that has not yet been assigned an exact physical or neurological function. You can think of them as microscopic packets of potential that stay on high alert for signals telling them where they are needed and what type of cell they need to become.Bone marrow stem cells are multipotent, which means they have the ability to become virtually any type of tissue cell, including:

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Morristown Ophthalmology Associates offers patient financing with Wells Fargo. Please contact our office to learn more about your available options.

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Academic neurologists are seeing many patients with neurological diseases interested in or receiving unapproved stem cell-based treatments, sometimes with negative health and/or financial consequences, according to a U.S. survey of neurologists.

The data were reported byWijdan Rai, MD, from Ohio State University in aposter titled Complications of Stem Cell Tourism in Multiple Sclerosis & Other Neurological Diseases: Results from First Nationwide Survey of Academic Neurologists on March 1 atthe 4thAnnual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forumin Dallas, Texas.

Stem cell tourism is a blanket term used to describe clinics (in the U.S. or abroad) that offer unproven cell-based interventions to patients with debilitating diseases, such as Parkinsons disease and amyotrophic lateral sclerosis. The phenomenon of stem cell tourism is rising among patients with neurological diseases, including multiple sclerosis (MS).

According to Rai, an alarming number of stem cell clinics have been accessible to patients, and the need for education has been identified.

Academic neurologists often see patients withcomplications due to stem cell tourism. But, the experiences and challenges that neurologists face in the outpatient practices is unknown, Rai said.

Understanding the experiences of neurologists with patients of stem cell tourism is critical to develop a strategy to educatepatients about it. In fact, a fair amount of neurologists had said that they would find really helpful to have some sort of educational tool, because they were not prepared to answer certain questions about stem cell tourism and its complications, said Rai.

To fill this knowledge gap, researchers fromThe Ohio State Universitydeveloped a 25-question survey focused on academic neurologists in the U.S. and their experiences with and attitudes about stem cell tourism, and associated patient-reported complications. The survey wasdistributed using a web toolcalled Synapse to members of the American Academy of Neurology.

Academic neurologists were targeted because they have specialized and informed knowledge about experimental cell-based therapies. In total, 204 across the U.S. completed the survey, andwere specialized in a range of neurological fields, with about one-third of them specializing in MS.

The survey results showed that nine out of 10 neurologists (91%) had been asked about stem cell treatments by patients or family members/caregivers 37% of these patients had an MS diagnosis.

About two out of three respondents (65%) had a patient who had received stem cell therapies.

Patients most often wanted general information about stem cell therapies from their neurologists. Half of the patients requested permission to undergo a stem cell procedure, and 31% approached their neurologist after the procedure.

Among patients undergoing stem cell treatment,33% reported the treatment was performed in the U.S., 22% reported going abroad, and37% reported procedures both in the U.S. and abroad. The procedures abroad were performed inChina, Germany, the Bahamas, Mexico, Russia, and Costa Rica.

Rai said 75% of the physicians indicated that no patient experienced complications from these unapproved stem-cell-based treatments.

However, one in four (25%) reported seeing patients who experienced complications, such as infections, MS deterioration and relapse, stroke, meningoencephalitis, sepsis, tumors, hepatitis C, seizures, or spinal cord injury.

At least three neurologists had patients who died from unapproved stem cell procedures.

These results are sad, Rai toldMS News Today, because there is actually legit, approved research happening on stem cell therapy, and their complication rate is very low. So its tough to see that it can be done really well, but when its done in a sort of unregulated or unapproved sort of fashion, you can not only have a lot of these kind of complications, but also have a huge financial burden.

According to the researcher,patients reported significant financial burden with no benefit, with treatments costing $20,000 to $25,000, up to $80,000 per procedure.

Stem cell tourism is an emerging public health threat, and the resultsdemonstrate an alarming number of unreported complications and negative impact to MS patients, Rai said.

Therefore, the team believes in a multipronged approach to improve the education of MS patients to prevent exploitation and engaging multiple stakeholders in the field, including MS academic societies, licensing boards,and legislative bodies.

Specifically, the researchers suggested the creation of evidence-based education for neurologists and patients, including resources that neurologists can use when discussing stem cell interventions with patients, and videos on proper counseling during these visits, Rai noted.

The team also advocated for the creation of a publicly available national registry where stem cell tourism complications must be reported, and the development of guidelines on how to care for patients who have undergone experimental stem cell procedures with tumor formation, Rai said.

The researcher said that as a physician, you have to respect patients autonomy, and at the end of the day it is their decision, but we also have to keep in mind that we (physicians) have to do what is best for them and communicate that to (our) patients.

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The UK Cystic Fibrosis Gene Therapy Consortium, Boehringer Ingelheim, Imperial Innovations and Oxford BioMedica Announce New Partnership to Develop First-In-Class Gene Therapy for Cystic Fibrosis

As many of you will know, the UK CF Gene Therapy Consortium (GTC) has brought together teams at Imperial College London and the Universities of Oxford and Edinburgh to vigorously pursue a single goal for the last 17 years, namely to establish whether gene therapy can become a clinically viable option for patients with CF. This form of treatment needs new copies of the CF gene to be introduced into the cells lining the lung, which is hard to achieve because these cells have evolved to keep external molecules out. The CF gene has to be carried past these defences, achievable either by surrounding it with fat (liposomes) or by inserting the CF gene inside a viral vector. Because of these defences, the GTC anticipated that successful gene therapy would require us to investigate several products, with incremental increases in knowledge helping us to overcome these barriers. We introduced the terms Wave 1 (the best liposome available at that time), and Wave 2 (the best viral vector we believe is currently available).

Supported by the CF community, and thereby predominantly funded by the Cystic Fibrosis Trust, we developed the Wave 1 product (the CF gene delivered via a liposome). Subsequently, funded by the National Institute for Health Researchs Efficacy and Mechanism Evaluation (EME) programme, we were able for the first time to demonstrate a significant benefit in lung function compared with placebo in the worlds largest CF gene therapy trial. Since the trial ended, we have spent considerable time presenting the product to the pharmaceutical industry, as it is these companies who have the resources to carry it through to the next step. The consistent response was that whilst they are impressed with the data, they wish to see a higher level of efficacy (which was slightly less than that produced by Orkambi). This boost could be produced by increasing the dose, increasing the dosing frequency, or trying a different type of liposome. We are exploring these possibilities and if this can be achieved, we will reopen these negotiations with a view to supporting a further clinical trial.

In parallel, we have been working for over a decade with a Japanese biotechnology company (DNAVEC, now called ID Pharma), building on knowledge from the Wave 1 programme, and have developed an alternative viral vector to deliver the CF gene (Wave 2 product). Support from the MRC DPFS programme and the Cystic Fibrosis Trust has brought this product to a stage where it can now undergo toxicology testing and larger-scale manufacturing; we have also recently received funding from the Health Innovation Challenge Fund, a collaboration between the Wellcome Trust and the Department of Health and Social Care, to undertake the next steps. We would also like to take this opportunity to warmly thank all of our supporters over many years, including Just Gene Therapy and Flutterby FUNdraisers.

It is now with great pleasure and excitement that we can add the next piece of the puzzle. The GTC is joining forces with two world class organisations in a major collaboration. We will work in partnership with Boehringer Ingelheim, who are an internationally renowned big pharma company with substantial expertise in bringing products through to patients, including in the respiratory field, and also with Oxford BioMedica who are the acknowledged leaders in the field of manufacturing the type of virus we have established as our Wave 2 product. The three partners are coming together to translate the Wave 2 product into clinical trials, and if successful, into routine clinical practice.

The GTC believes that this partnership provides CF patients with the optimal chance to establish gene therapy as routine clinical practice, relevant to all patients irrespective of their mutation status, and in due course to both prevent lung disease as well as treat established problems. Importantly, we can of course offer no guarantee of success, building this programme will not happen overnight and the therapy will only be focused on the problems occurring in the lungs.

We believe this new partnership of three world leading organisations has the greatest chance of realising a parallel new therapeutic pathway for CF patients, and better still, one that will add to the improvements already being seen with small molecule treatments. The gene therapy may have additional benefits: currently we envisage the effect of a single dose lasting for many months or even longer and it is unlikely that gene therapy will suffer from drug-drug interactions. We will regularly update on progress on this website as this exciting programme now unfolds.

7 months ago

The UKCFGTC is pleased to announce that we have received 2.7M to undertake a Phase l/lla nose trial in CF patients using our Wave 2 product, delivering the CFTR gene using a novel lentivirus. This latest support, which builds on many years of gene therapy funding from the Cystic Fibrosis Trust, the National Institute for Health Research(NIHR) and the Medical Research Council(MRC), has been awarded by the Wellcome Trust/Department of Healths Health Innovation Challenge Fund (HICF).

At the same time the Cystic Fibrosis Trusthave awarded an additional 0.5M to continue to support the scientific work underpinning this latest trial over the next two years.

We aim to recruit 24 patients into the Phase l/lla nose trial which will last around 9 months. The study will assess safety, and any changes in molecular endpoints, to provide evidence for the efficacy of the lentivirus. The start point of the trial will depend on the time required for manufacture of the Wave 2 product for clinical delivery; we will further update on timelines once these manufacturing data are available.

We are now focusing our research and development efforts on Wave 2, which has proved to be considerably more efficient than the Wave 1 product (delivering the CFTR gene via liposomes). However, the latter, which led to a stabilisation of lung function significantly different to the decline seen in a placebo group, continues to be discussed with potential commercial partners. We will update further on the outcome of these discussions as soon as possible.

1 year ago

The Consortium are pleased to announce the publication of the results from our multi dose gene therapy clinical trial inLancet Respiratory Medicine.

One hundred and thirty six patients aged 12 and above were randomly assigned to either 5ml of nebulised pGM169/GL67A (gene therapy) or saline (placebo) at monthly intervals over 1 year. Lung function was evaluated using a common clinical measure FEV1.

The clinical trial reached its primary endpoint with patients who received therapy having a significant, if modest benefit in lung function compared with those receiving a placebo. After a year of treatment, in the 62 patients who received the gene therapy, FEV1 was 3.7% greater compared to placebo.

The trial is the first ever to show that repeated doses of a gene therapy can have a meaningful effect on the disease and change the lung function of patients.

More details here.

3 years ago

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The UK Cystic Fibrosis Gene Therapy Consortium

In this article we will discuss about Nano Medicine:- 1. Meaning of Nano Medicine 2. Advantages of Nano Medicine 3. Disadvantages.

The application of nanotechnology in medicine is often referred to as Nano medicine. Nano medicine is the preservation and improvement of human health using molecular tools and molecular knowledge of the human body. It covers areas such as nanoparticle drug delivery and possible future applications of molecular nanotechnology (MNT) and Nano-vaccinology.

The human body is comprised of molecules. Hence, the availability of molecular nanotechnology will permit dramatic progress in human medical services. More than just an extension of molecular medicine, Nano medicine will help us understand how the biological machinery inside living cells operates at the Nano scale so that it can be employed in molecular machine systems to address complicated medical conditions such as cancer, AIDS, ageing and thereby bring about significant improvement and extension of natural human biological structure and function at the molecular scale.

Nano medical approaches to drug delivery centre on developing Nano scale particles or molecules to improve drug bioavailability that refers to the presence of drug molecules in the body part where they are actually needed and will probably do the most good. It is all about targeting the molecules and delivering drugs with cell precision.

The use of Nano robots in medicine would totally change the world of medicine once it is realized. For instance, by introducing these Nano robots into the body damages and infections can be detected and repaired. In short it holds that capability to change the traditional approach of treating diseases and naturally occurring conditions in the human beings.

1. Advanced therapies with reduced degree of invasiveness.

2. Reduced negative effects of drugs and surgical procedures.

3. Faster, smaller and highly sensitive diagnostic tools.

4. Cost effectiveness of medicines and disease management procedures as a whole.

5. Unsolved medical problems such as cancer, benefiting from the Nano medical approach.

6. Reduced mortality and morbidity rates and increased longevity in return.

1. Lack of proper knowledge about the effect of nanoparticles on biochemical pathways and processes of human body.

2. Scientists are primarily concerned about the toxicity, characterization and exposure pathways associated with Nano medicine that might pose a serious threat to the human beings and environment.

3. The societys ethical use of Nano medicine beyond the concerned safety issues, poses a serious question to the researchers.

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Nano Medicine: Meaning, Advantages and Disadvantages

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Nanobiotix a nanomedicine company

Precision medicine and pharmacogenomics

Personalized medicine holds the promise that treatments will one day be tailored to your genetic makeup.

Modern medications save millions of lives a year. Yet any one medication might not work for you, even if it works for other people. Or it might cause severe side effects for you but not for someone else.

Your age, lifestyle and health all influence your response to medications. But so do your genes. Pharmacogenomics is the study of how a person's unique genetic makeup (genome) influences his or her response to medications.

Precision medicine aims to customize health care, with decisions and treatments tailored to each individual in every way possible. Pharmacogenomics is part of precision medicine.

Although genomic testing is still a relatively new development in drug treatment, this field is rapidly expanding. Currently, more than 200 drugs have label information regarding pharmacogenomic biomarkers some measurable or identifiable genetic information that can be used to individualize the use of a drug.

Each gene provides the blueprint for the production of a certain protein in the body. A particular protein may have an important role in drug treatment for one of several reasons, including the following:

When researchers compare the genomes of people taking the same drug, they may discover that a set of people who share a certain genetic variation also share a common treatment response, such as:

This kind of treatment information is currently used to improve the selection and dosage of drugs to treat a wide range of conditions, including cardiovascular disease, lung disease, HIV infection, cancer, arthritis, high cholesterol and depression.

In cancer treatments, there are two genomes that may influence prescribing decisions the genome of the person with cancer (the germline genome) and the genome of the cancerous (malignant) tumor (the somatic genome).

There are many causes of cancer, but most cancers are associated with damaged DNA that allows cells to grow unchecked. The "incorrect" genetic material of the unchecked growth the malignant tumor is really a separate genome that may provide clues for treatment.

One example is thiopurine methyltransferase (TPMT) testing for people who are candidates for thiopurine drug therapy. Thiopurine drugs are used to treat some autoimmune disorders, including Crohn's disease and rheumatoid arthritis, as well as some types of cancer, such as childhood leukemia.

The TPMT enzyme helps break down thiopurine drugs. People who are TPMT deficient don't break down and clear out these drugs quickly enough. As a result, the drug concentration in the body is too high and increases the risk of side effects, such as damage to the bone marrow (hematopoietic toxicity).

Genetic testing can identify people with TPMT deficiency so that their doctors can take steps to reduce the risk of serious side effects by prescribing lower than usual doses of thiopurine drugs or by using other drugs instead.

Although pharmacogenomics has great promise and has made important strides in recent years, it's still in its early stages. Clinical trials are needed not only to identify links between genes and treatment outcomes but also to confirm initial findings, clarify the meaning of these associations and translate them into prescribing guidelines.

Nonetheless, progress in this field points toward a time when pharmacogenomics will be part of routine medical care at least for some drugs.

.

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Precision medicine and pharmacogenomics - Mayo Clinic

The university affirmatively strives to provide educational opportunities and access to students with varied backgrounds, those with special talents and adult students who graduated from high school three or more years ago.

Freshman Students on the Kent Campus: The freshman admission policy on the Kent Campus is selective. Admission decisions are based upon the following: cumulative grade point average, ACT and/or SAT scores, strength of high school college preparatory curriculum and grade trends. The Admissions Office at the Kent Campus may defer the admission of students who do not meet admissions criteria but who demonstrate areas of promise for successful college study. Deferred applicants may begin their college coursework at one of seven regional campuses of Kent State University. For more information on admissions, including additional requirements for some academic programs, visit the admissions website for new freshmen.

Freshman Students on the Regional Campuses: Kent State campuses at Ashtabula, East Liverpool, Geauga, Salem, Stark, Trumbull and Tuscarawas, as well as the Regional Academic Center in Twinsburg, have open enrollment admission for students who hold a high school diploma, GED or equivalent.

English Language Proficiency Requirements for International Students: All international students must provide proof of English language proficiency (unless they meet specific exceptions) by earning a minimum 525 TOEFL score (71 on the Internet-based version), minimum 75 MELAB score, minimum 6.0 IELTS score or minimum 48 PTE score, or by completing the ESL level 112 Intensive Program. For more information on international admission, visit the Office of Global Educations admission website.

Transfer, Transitioning and Former Students: For more information about admission criteria for transfer, transitioning and former students, please visit the admissions website.

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Biotechnology - B.S. < Kent State University

Johns Hopkins is a world leader in biological research and the global biotechnology industry. We challenge students with a rigorous, multi-disciplinary curriculum that fully prepares them to advance their careers and pursue their academic ambitions in the biotechnology field.Program InformationCourse LocationsBaltimore, MD; Rockville, MD; OnlineAvailable 100% OnsiteYesAvailable 100% OnlineYes*Entry TermsFall, Spring or Summer semesterDegree Requirements10 coursesTuition and FeesTuition in the 2019-2020 academic year is $4,495 per course.Please note: 2019-2020 tuition rates are tentative pending approval by the Board of Trustees.More information.

The Johns Hopkins MS in Biotechnology offers a comprehensive exploration of basic science, applied science, and lab science, with an industry focus. The program gives you a solid grounding in biochemistry, molecular biology, cell biology, genomics, and proteomics.

This 10-course degree program is thesis-optional and can be completed fully online. Students can enroll part-time or full-time. This Program offers a sufficient number of onsite courses to sustain students coming to the US on visas. Our curriculum will prepare you to engage in research, lead lab teams, make development and planning decisions, create and apply research modalities to large projects, and take the reins of management and marketing decisions.

Many students like the flexibility of the general degree; it allows them to tailor the coursework to meet their individual career goals. The program also offers six different concentrations: biodefense, bioinformatics, biotechnology enterprise, regenerative and stem cell technologies, regulatory affairs, or drug discovery.

Onsite courses are taught during evenings or weekends at either the universitys Homewood Campus in Baltimore, MD or the Montgomery County Campus in Rockville, MD. Courses are also offered in our state-of-the-art lab.

Each year, students of the MS in Biotechnology have the opportunity to apply for a fellowship with the National Cancer Institute at NIH. This fellowship, which requires onsite research as well as onsite courses for the Molecular Targets and Drug Discovery Technologies concentration at the Montgomery Count Campus, awards students with a stipend while providing them with useful experience in the arena of cancer research. Learn more about this fellowship and apply here.

*Note: Students should be aware of state-specific information for online programs. For more information, please contact an admissions representative.

See more here:
Biotechnology | Advanced Academic Programs | Johns Hopkins ...

This book is meant for students and professionals who are looking for reference on different areas in this field, to bring a new student or new hire up to speed.

A scientific revolution less than 20 years old that has already changing the foods we eat and react to the environment.

To bring out the best in nature.

Farmers and bakers were the pioneers of the biotech. Remember Grandma's freshly baked bread? How Grandpa kept the seeds of those really big pepper or tomatoes? Your grandparents were practicing biotechnology. Maybe you still do the same, that is the basis of biotechnology.

Defining "Biotechnology"

The application of the principles of engineering and the use of technology in the field of life sciences-bioengineering.

1 The use of living things to make products.2 The study, application and control of a biological processes. 3 The application of any of the above or derivatives thereof, to make or modify products or processes for specifically defined uses.

The use of microorganisms (such as bacteria or yeasts) or biological substances (such as enzymes) to perform specific industrial or manufacturing processes. Applications include the production of certain drugs, synthetic hormones, and bulk foodstuffs, as well as the bioconversion of organic waste and the cleanup of oil spills.

Cloning, genetic manipulation, cell fusion, and mutation.

Modifying the genetic material of organisms directly and with increasing precision, has enabled the transfer of genes between extremely diverse organisms, in combinations unlikely to occur by non-technological means, allowing speedier and more specific results.

Essentially, doing "more and faster" building on what we have known and done for centuries and going beyond.

Life- Defined as:

Products

Good laboratory practice for nonclinical laboratory studies:

http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr58_02.html

Title 21 Code of Federal Regulations (21 CFR Part 11)Electronic Records; Electronic Signatures

http://www.fda.gov/ora/compliance_ref/part11/

Part 210 - current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general

Part 211 - current good manufacturing practice for finished pharmaceuticals

http://www.fda.gov/cder/dmpq/cgmpregs.htm

SOP's (Standard Operating Procedures)

Notebook

Documentation for Integrity and traceability

Keys to Successful Biotech products

Record Keeping

requirements

Development / Upstream / Downstream processes

Chemical

Yeast

Fungi

Mammalian Cells

Fermentation?

ExpensiveLabor intensiveOpen EndedTime Consuming

Raw MaterialsBatch to Batch variationsTransportation costsStorage

CompositionGrowth kineticsYieldSeed Bank

Original Stored Cells

Used in actual fermentation

The Biotech Technician must be a person possessing skills with ability to solve problems and meet the customer in such a way that the translations of what is possible can be made clear. They have to maintain a notebook, one that can be read by someone else. Present results in a clear manner, and work with others to meet objectives.

A technician must use the tools of the trade not unlike any other trade, we are farmers but our herd is tiny tiny wildlife. To take care of our herd we must measure certain aspects of their environment.

most accuratemore expensive piece of equipmentStore in bufferCheck for clogging

very coarse measurement of pH

The letters pH stand for "power of hydrogen"

The most abundant element in the universe is hydrogen, which makes up about 3/4 of all matter!

Stronger acids give up more protons, H+ (hydrogen ions); stronger bases give up more OH- (hydroxide ions). Neutral substances have an even balance of H+ and OH-, E.g. Pure (distilled) water.

>7 base -- 7 Neutral -- <7 Acid

Depending on your definition, an acid is a hydrogen ion or proton donator and a base is a hydrogen ion acceptor, hydroxide ion donator, or electron acceptor.

Acids produce H+ ions in aqueous solutions, whereas bases produce OH- ions in aqueous solutions

pH electrode compared to a battery

Store in buffer not H2O

Mercury tubeGood for metals and biologicals and up to 80 degrees C

The common Silver-Silver Chloride reference electrode used with most combination pH electrodes has a Potassium Chloride salt-bridge which is saturated with Silver Chloride.

Works well in most samples, but not in biological samples containing proteins or related materials

Span errorDifference b/w perfect and actual pH Electrode at 25C produces 59.12 mV/pH unit

Offset error

signal @ pH 7.0 @ 25 C is 0 mV

Three point calibration

Calibrate W/I range you going to use

Chemist use buffers to moderate the pH of a reaction.Buffers stabilize a solution at a specific pH value.Resist pH change when small amounts of acid or alkali are added.

KPO4

KPO4 buffer is highly recommended for most P450 assays (microsomal or recombinant enzymes) with the exception of CYP 2C9 and 2A6 where a Tris buffer system is more appropriate.

TRIS buffer

TRIS buffers are used by biochemists to control pH in the physiological range (about 7 to 8 pH) because phosphates cause undesirable side reactions with the biological substances in their test samples.

"Good" buffers

These buffers were well received by the research community because "Good" buffers are nontoxic, easy to purify and their pKa is typically between 6.0 and 8.0, the range at which most biological reactions occur.

The "Good" buffers also feature minimal penetration of membranes, minimal absorbance in the 240-700 nm range and minimal effects due to salt, concentration or temperature.

pKa = dissociation constant

In chemistry and biochemistry, a dissociation constant or an ionization constant is a specific type of equilibrium constant used for dissociation (ionization) reactions.Dissociation in chemistry and biochemistry is a general process in which complexes, molecules, or salts separate or split into smaller molecules, ions, or radicals, usually in a reversible manner. Dissociation is the opposite of association and recombination.

Problems

A gelatinous material derived from certain marine algae.

Two types:

Components required for preparing a minimal agar

LB (Luria-Bertani) Media

contains blood cells from an animal (e.g. a sheep). Most bacteria will grow on this medium

This contains lysed blood cells, and is used for growing fastidious (fussy) respiratory bacteria.

Purpose Mannitol salt agar is both a selective and differential growth medium.

Inhibits Gram+MacConkey

This type of agar is used since it is one of the most forgiving media available - it is hard to contaminate, and E. coli usually grow up as red colonies.

(Almost all spore forming bacteria are Gram-positive, but these cannot grow on MacConkey agar because of the detergent in it (bile salts), and very few Gram-negative bacteria can tolerate either the initial dryness of the plates, or the boiling temperatures needed to make the MacConkey agar. Also, while fungal spores can tolerate the dryness, they cannot tolerate the boiling.)

This is an agar upon which only Gram-negative bacteria can grow

Starch

An agar plate is a sterile Petri dish that contains agar plus nutrients, and is used to culture bacteria or fungi.

contains the antibiotic neomycin.

Used for fungi. It contains gentamicin and has a low pH that will kill most bacteria.

+ Complex+ pH 7.2

Common UV/ VIS spectrophotometers Following is a list of commonly used spectrophotometers: GeneSys 20 HP8452A Diode Array Spectronic 20

Ultraviolet-Visible spectroscopy or Ultraviolet-Visible spectrophotometry (UV/ VIS) involves the spectroscopy of photons (spectrophotometry). It uses light in the visible and adjacent near ultraviolet (UV) and near infrared (NIR) ranges. In this region of energy space molecules undergo electronic transitions.

A=elc

There are different types of Sterilization techniques. Some of them are 1. Physical sterilization 2. Chemical sterilization

Under Physical sterilization a) Heatb) Filtration c) Ionising Radiation etc.,In Heat sterilization i. Temperature above 100 Cii. Temperature at 100 Ciii. Temperature below 100 C.

i. Temperature above 100 CThere are two methods involved in it a. Moisture heat sterilizationb. Dry heat sterilization

Using a balanceCalibration / documentation

Gel electrophoresis is a method that separates macromolecules-either nucleic acids or proteins-on the basis of size, electric charge, and other physical properties. Researchers can typically control the charge at the top and bottom of the gel. DNA is negatively charged so to run it through the gel, the top would have to be set to - and the bottom to +.

materials

agarose

Agarose is a natural colloid extracted from sea weedIt is very fragile and easily destroyed by handlingAgarose gels have very large "pore" size and are used primarily to separate very large molecules with a molecular mass greater than 200 kDaltonsAgarose gels can be processed faster than polyacrylamide gels, but their resolution is inferior.

Agarose is a linear polysaccharide (average molecular mas about 12,000) made up of the basic repeat unit agarobiose, which comprises alternating units of galactose and 3,6-anhydrogalactose. Agarose is usually used at concentrations between 1% and 3%. Agarose is a chain of sugar molecules, and is extracted from seaweed.

Perhaps you have seen the terms TBE or TAE.

These are names of two commonly used buffers in electrophoresis.

The "T" stands for Tris, a chemical which helps maintain a consistent pH of the solution.

The "E" stands for EDTA, which itself is another anacronym. EDTA chelates (gobbles up) divalent cations like magnesium. This is important because most nucleases require divalent cations for activity, and you certainly wouldn't want any stray nucleases degrading your sample while it's running through the gel, would you?

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Biotechnology - Wikibooks, open books for an open world

Genetically engineered (GE) seed varieties were commercially introduced in 1996. Adoption rates for these crops increased rapidly in the years that followed. Currently, over 90 percent of U.S. corn, upland cotton, soybeans, canola, and sugarbeets are produced using GE varieties.

HT crops tolerate potent herbicides (such as glyphosate, glufosinate, and dicamba), which have the potential to damage non-GE crops. Insect-resistant (Bt) crops contain a gene from the soil bacteriumBacillus thuringiensisthat produces an insecticidal protein. Although other GE traits have been developed (such as virus and fungus resistance, drought resistance, and enhanced protein, oil, or vitamin content), HT and Bt traits are the most commonly used in U.S. crop production. While HT seeds are also widely used in alfalfa, canola, and sugar beet production, most GE acres are planted to three major field crops: corn, cotton, and soybeans.

See Adoption of Genetically Engineered Crops in the U.S., a data product on the ERS website, for more information.

Though GE seeds tend to be more expensive than conventional ones, planting them tends to increase crop yields, lower pesticide costs, and/or provide time and labor savings. The impacts of GE crops vary by crop, year, and location. Bt crops tend to have higher yields than non-Bt crops when insects are present. Insecticide costs also tend to be lower on fields where Bt crops are planted. Planting HT crops tends to simplify weed management decisions, which can lead to time and labor savings. HT adoption also tends to promote the use of conservation tillage technologies and often induces farmers to substitute the herbicide glyphosate for more toxic herbicides. However, large increases in glyphosate use have recently led to the development of glyphosate-resistant weed populations. The spread of resistant weed populations has the potential to erode the benefits associated with HT production systems.

ERS conducts research on a number of agricultural biotechnology issues, including:

A book from the National Research Council titled The Impact of Genetically Engineered Crops on Farm Sustainability in the United States (2010) is a comprehensive assessment of the environmental, economic, and social impacts of the GE-crop revolution on U.S. farms.

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USDA ERS - Biotechnology

Some examples of biotechnology include human gene therapy, genetically modifying plants and changing the genes of bacteria. Biotechnology helps improve crops so they produce more, healthier produce. It also helps fight human diseases.

Biotechnology is generally involved in changing the genes of a an organism to get the desired result. It affects the most people through genetically modified crops. Genetic modification of crops started thousands of years ago through selective breeding for preferred traits, but with the advances in technology in the modern day, scientists are able to directly manipulate genes. These plants produce higher quality food at a higher rate, and are often resistant to pests and diseases, which helps feed larger amounts of people for a lower price on less land.

Biotechnology more directly helps humans with gene therapy and the modification of bacteria to produce insulin for patients with diabetes. Gene therapy can help reduce or remove the effects of a disease, such as cancer or AIDS, but is still mostly in research and development. This type of therapy is still promising and has had good results in testing phases. Modified bacteria cells that produce insulin as they age helps treat and control the effects of diabetes in humans over time.

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What Are Examples of Biotechnology? | Reference.com

Figure 1

The production of a a recombined bacterium using a gene from a foreign donor and the synthesis of protein encoded by the recombinant DNA molecule.

The genes used in DNA technology are commonly obtained from host cells or organisms calledgene libraries.A gene library is a collection of cells identified as harboring a specific gene. For example,E. colicells can be stored with the genes for human insulin in their chromosomes.

Pharmaceutical products.Gene defects in humans can lead to deficiencies in proteins such as insulin, human growth hormone, and Factor VIII. These protein deficiencies may lead to problems such as diabetes, dwarfism, and impaired blood clotting, respectively. Missing proteins can now be replaced by proteins manufactured through biotechnology. Forinsulinproduction, two protein chains are encoded by separate genes in plasmids inserted into bacteria. The protein chains are then chemically joined to form the final insulin product.Human growth hormoneis also produced within bacteria, but special techniques are used because the bacteria do not usually produce human proteins. Therapeutic proteins produced by biotechnology include a clot-dissolving protein calledtissue plasminogen activator (TPA)andinterferon.This antiviral protein is produced withinE. colicells. Interferon is currently used against certain types of cancers and for certain skin conditions.

Vaccinesrepresent another application of recombinant DNA technology. For instance, the hepatitis B vaccine now in use is composed of viral protein manufactured by yeast cells, which have been recombined with viral genes. The vaccine is safe because it contains no viral particles. Experimental vaccines against AIDS are being produced in the same way.

Diagnostic testing.Recombinant DNA and biotechnology have opened a new era of diagnostic testing and have made detecting many genetic diseases possible. The basic tool of DNA analyses is a fragment of DNA called the DNA probe. ADNA probeis a relatively small, single-stranded fragment of DNA that recognizes and binds to a complementary section of DNA in a complex mixture of DNA molecules. The probe mingles with the mixture of DNA and unites with the target DNA much like a left hand unites with the right. Once the probe unites with its target, it emits a signal such as radioactivity to indicate that a reaction has occurred.

To work effectively, a sufficiently large amount of target DNA must be available. To increase the amount of available DNA, a process called thepolymerase chain reaction (PCR)is used. In a highly automated machine, the target DNA is combined with enzymes, nucleotides, and a primer DNA. In geometric fashion, the enzymes synthesize copies of the target DNA, so that in a few hours billions of molecules of DNA exist where only a few were before.

Using DNA probes and PCR, scientists are now able to detect the DNA associated with HIV (and AIDS), Lyme disease, and genetic diseases such as cystic fibrosis, muscular dystrophy, Huntington's disease, and fragile X syndrome.

Gene therapy. Gene therapyis a recombinant DNA process in which cells are taken from the patient, altered by adding genes, and replaced in the patient, where the genes provide the genetic codes for proteins the patient is lacking.

In the early 1990s, gene therapy was used to correct a deficiency of the enzymeadenosine deaminase (ADA).Blood cells called lymphocytes were removed from the bone marrow of two children; then genes for ADA production were inserted into the cells using viruses as vectors. Finally, the cells were reinfused to the bodies of the two children. Once established in the bodies, the gene-altered cells began synthesizing the enzyme ADA and alleviated the deficiency.

Gene therapy has also been performed with patients withmelanoma(a virulent skin cancer). In this case, lymphocytes that normally attack tumors are isolated in the patients and treated with genes for an anticancer protein calledtumor necrosis factor.The genealtered lymphocytes are then reinfused to the patients, where they produce the new protein which helps destroy cancer cells. Approximately 2000 single-gene defects are believed to exist, and patients with these defects may be candidates for gene therapy.

DNA fingerprinting.The use of DNA probes and the development of retrieval techniques have made it possible to match DNA molecules to one another for identification purposes. This process has been used in a forensic procedure calledDNA fingerprinting.

The use of DNA fingerprinting depends upon the presence of repeating base sequences that exist in the human genome. The repeating sequences are calledrestriction fragment length polymorphisms (RFLPs).As the pattern of RFLPs is unique for every individual, it can be used as a molecular fingerprint. To perform DNA fingerprinting, DNA is obtained from an individual's blood cells, hair fibers, skin fragments, or other tissue. The DNA is extracted from the cells and digested with enzymes. The resulting fragments are separated by a process called electrophoresis. These separated DNA fragments are tested for characteristic RFLPs using DNA probes. A statistical evaluation enables the forensic pathologist to compare a suspect's DNA with the DNA recovered at a crime scene and to assert with a degree of certainty (usually 99 percent) that the suspect was at the crime scene.

DNA and agriculture.Although plants are more difficult to work with than bacteria, gene insertions can be made into single plant cells, and the cells can then be cultivated to form a mature plant. The major method for inserting genes is through the plasmids of a bacterium calledAgrobacterium tumefaciens. This bacterium invades plant cells, and its plasmids insert into plant chromosomes carrying the genes for tumor induction. Scientists remove the tumor-inducing genes and obtain a plasmid that unites with the plant cell without causing any harm.

Recombinant DNA and biotechnology have been used to increase the efficiency of plant growth by increasing the efficiency of the plant's ability to fix nitrogen. Scientists have obtained the genes for nitrogen fixation from bacteria and have incorporated those genes into plant cells. By obtaining nitrogen directly from the atmosphere, the plants can synthesize their own proteins without intervention of bacteria as normally needed.

DNA technology has also been used to increase plant resistance to disease. The genes for an insecticide have been obtained from the bacteriumBacillus thuringiensisand inserted into plants to allow them to resist caterpillars and other pests. In addition, plants have been reengineered to produce the capsid protein that encloses viruses. These proteins lend resistance to the plants against viral disease.

The human genome. One of the most ambitious scientific endeavors of the twentieth century was the effort to sequence the nitrogenous bases in thehuman genome. Begun in 1990 and completed in 2003, the effort encompassed 13 years of work at a cost of approximately $3 billion. Knowing the content of the human genome is helping researchers devise new diagnostics and treatments for genetic diseases and will also be of value to developmental biologists, evolutionary biologists, and comparative biologists.

In addition to learning the genome of humans, the project has also studied numerous bacteria. By 1995, the genomes of two bacteria had been completely deciphered (Haemophilus influenzaeandMycoplasma genitalium), and by 1996, the genome of the yeastSaccharomyces cerevisiaewas known. The Human Genome Project is one of colossal magnitude that will have an impact on many branches of science for decades to come. The project remains the crowning achievement of DNA research in the twentieth century and the bedrock for research in the twenty-first.

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Recombinant DNA and Biotechnology - CliffsNotes

Amniotic regenerative cell therapy is one of the newest and most cutting-edge therapies for chronic joint pain. Amniotic derived regenerative cell therapy offers patients 3 essential properties for healing and restoring joint health:

Since amniotic derived regenerative cell therapy is not derived from embryonic stem cells or fetal tissue, there are no ethical issues with the treatment. The amniotic regenerative cell therapy consists of an injection directly into the painful area. The therapy has the potential to actually alter the course of the condition and not simply mask the pain. This therapy has significant potential for those in pain, and could actually repair structural problems while treating pain and inflammation simultaneously. When the amniotic cell material is obtained, it comes from consenting donors who have undergone elective c-sections. The fluid is processed at an FDA regulated lab, and is checked for a full slate of diseases per FDA guidelines. The amniotic material has been used over 60,000 times in the US with no adverse events reported. It acts as an immunologically privileged material, meaning it has NOT been shown to cause any rejection reaction in the body. This means there is no graft versus host problem.

Our services are provided by Dr. John Biery D.O. F.A.O.S.M. F.A.C.S.M. F.A.C.O.F.P

Lauren Sherer P.A.-C

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Stem Cell Therapy | Ohio Stem Cell