StemCell Therapy

Almost every human trait and disease has a genetic component, whether inherited orinfluenced by behavioral factors such as exercise. Genetic components can also modifythe bodys response to environmental factors such as toxins. Understanding theunderlying concepts of human genetics and the role of genes, behavior, and theenvironment is important for appropriately collecting and applying genetic and genomicinformation and technologies during clinical care. It is important in improving diseasediagnosis and treatment as well. This chapter provides fundamental information aboutbasic genetics concepts, including cell structure, the molecular and biochemical basisof disease, major types of genetic disease, laws of inheritance, and the impact ofgenetic variation.

Cells are the fundamental structural and functional units of every known livingorganism. Instructions needed to direct activities are contained within a DNA(deoxyribonucleic acid) sequence. DNA from all organisms is made up of the samechemical units (bases) called adenine, thymine, guanine, and cytosine, abbreviatedas A, T, G, and C. In complementary DNA strands, A matches with T, and C with G, toform base pairs. The human genome (total composition of genetic material within acell) is packaged into larger units known as chromosomesphysically separatemolecules that range in length from about 50 to 250 million base pairs. Human cellscontain two sets of chromosomes, one set inherited from each parent. Each cellnormally contains 23 pairs of chromosomes, which consist of 22 autosomes (numbered 1through 22) and one pair of sex chromosomes (XX or XY). However, sperm and ovanormally contain half as much genetic material: only one copy of eachchromosome.

Each chromosome contains many genes, the basic physical and functional units ofheredity. Genes are specific sequences of bases that encode instructions for how tomake proteins. The DNA sequence is the particular side-by-side arrangement of basesalong the DNA strand (e.g., ATTCCGGA). Each gene has a unique DNA sequence. Genescomprise only about 29 percent of the human genome; the remainder consists ofnon-coding regions, whose functions may include providing chromosomal structuralintegrity and regulating where, when, and in what quantity proteins are made. Thehuman genome is estimated to contain 20,000 to 25,000 genes.

Although each cell contains a full complement of DNA, cells use genes selectively.For example, the genes active in a liver cell differ from the genes active in abrain cell because each cell performs different functions and, therefore, requiresdifferent proteins. Different genes can also be activated during development or inresponse to environmental stimuli such as an infection or stress.

Many, if not most, diseases are caused or influenced by genetics. Genes, through theproteins they encode, determine how efficiently foods and chemicals are metabolized,how effectively toxins are detoxified, and how vigorously infections are targeted.Genetic diseases can be categorized into three major groups: single-gene,chromosomal, and multifactorial.

Changes in the DNA sequence of single genes, also known as mutations, cause thousandsof diseases. A gene can mutate in many ways, resulting in an altered protein productthat is unable to perform its normal function. The most common gene mutationinvolves a change or misspelling in a single base in the DNA.Other mutations include the loss (deletion) or gain (duplication or insertion) of asingle or multiple base(s). The altered protein product may still retain some normalfunction, but at a reduced capacity. In other cases, the protein may be totallydisabled by the mutation or gain an entirely new, but damaging, function. Theoutcome of a particular mutation depends not only on how it alters aproteins function, but also on how vital that particular protein is tosurvival. Other mutations, called polymorphisms, are natural variations in DNAsequence that have no adverse effects and are simply differences amongindividuals.

In addition to mutations in single genes, genetic diseases can be caused by largermutations in chromosomes. Chromosomal abnormalities may result from either the totalnumber of chromosomes differing from the usual amount or the physical structure of achromosome differing from the usual structure. The most common type of chromosomalabnormality is known as aneuploidy, an abnormal number of chromosomes due to anextra or missing chromosome. A usual karyotype (complete chromosome set) contains 46chromosomes including an XX (female) or an XY (male) sex chromosome pair. Structuralchromosomal abnormalities include deletions, duplications, insertions, inversions,or translocations of a chromosome segment. (See Appendix F for more information aboutchromosomal abnormalities.)

Multifactorial diseases are caused by a complex combination of genetic, behavioral,and environmental factors. Examples of these conditions include spina bifida,diabetes, and heart disease. Although multifactorial diseases can recur in families,some mutations such as cancer can be acquired throughout an individualslifetime. All genes work in the context of environment and behavior. Alterations inbehavior or the environment such as diet, exercise, exposure to toxic agents, ormedications can all influence genetic traits.

The basic laws of inheritance are useful in understanding patterns of diseasetransmission. Single-gene diseases are usually inherited in one of several patterns,depending on the location of the gene (e.g., chromosomes 1-22 or X and Y) andwhether one or two normal copies of the gene are needed for normal protein activity.Five basic modes of inheritance for single-gene diseases exist: autosomal dominant,autosomal recessive, X-linked dominant, X-linked recessive, and mitochondria. (Seediagram on following page.)

All individuals are 99.9 percent the same genetically. The differences in thesequence of DNA among individuals, or genetic variation, explain some of thedifferences among people such as physical traits and higher or lower risk forcertain diseases. Mutations and polymorphisms are forms of genetic variation. Whilemutations are generally associated with disease and are relatively rare,polymorphisms are more frequent and their clinical significance is not asstraightforward. Single nucleotide polymorphisms (SNPs, pronouncedsnips) are DNA sequence variations that occur when a singlenucleotide is altered. SNPs occur every 100 to 300 bases along the 3 billion-basehuman genome. A single individual may carry millions of SNPs.

Although some genetic variations may cause or modify disease risk, other changes mayresult in no increased risk or a neutral presentation. For example, genetic variantsin a single gene account for the different blood types: A, B, AB, and O.Understanding the clinical significance of genetic variation is a complicatedprocess because of our limited knowledge of which genes are involved in a disease orcondition and the multiple gene-gene and gene-behavior-environment interactionslikely to be involved in complex, chronic diseases. New technologies are enablingfaster and more accurate detection of genetic variants in hundreds or thousands ofgenes in a single process.

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GENETICS 101 - Understanding Genetics - NCBI Bookshelf

People always think Im skinny because of good genetics theyre shocked when they see what I used to lo...  The US Sun

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People always think Im skinny because of good genetics theyre shocked when they see what I used to lo... - The US Sun

Procedure to Surgery for Arthritis Is Recommended After First Failed Non-Operative Therapy  DocWire News

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OverviewYour immune system is made of up a complex collection of cells and organs. The system works together to protect you from germs and helps you get better when you get sick.What is the immune system?

Your immune system is a large network of organs, white blood cells, proteins (antibodies) and chemicals. This system works together to protect you from foreign invaders (bacteria, viruses, parasites, and fungi) that cause infection, illness and disease.

Your immune system works hard to keep you healthy. Its job is to keep germs out of your body, destroy them or limit the extent of their harm if they get in.

When your immune system is working properly: When your immune system is working properly, it can tell which cells are yours and which substances are foreign to your body. It activates, mobilizes, attacks and kills foreign invader germs that can cause you harm. Your immune system learns about germs after youve been exposed to them too. Your body develops antibodies to protect you from those specific germs. An example of this concept occurs when you get a vaccine. Your immune system builds up antibodies to foreign cells in the vaccine and will quickly remember these foreign cells and destroy them if you are exposed to them in the future. Sometimes doctors can prescribe antibiotics to help your immune system if you get sick. But antibiotics only kill certain bacteria. They dont kill viruses.

When your immune system is not working properly: When your immune system cant mount a winning attack against an invader, a problem, such as an infection, develops. Also, sometimes your immune system mounts an attack when there is no invader or doesnt stop an attack after the invader has been killed. These activities result in such problems as autoimmune diseases and allergic reactions.

Your immune system is made of up a complex collection of cells and organs. They all work together to protect you from germs and help you get better when youre sick. The main parts of the immune system are:

Many deficiencies and disorders can damage or disrupt your immune system. Some medicines make it harder for your body to fight infection. Certain health conditions cause your immune system to attack healthy cells or make it hard for your immune system to protect you from harmful germs. They include:

Just like the rest of your body, your immune system needs nourishment, rest, and a healthy environment to stay strong. Certain lifestyle changes can boost your immune system and help you avoid illness. To keep your immune system running smoothly, you should:

If you feel like youre always sick or you have symptoms that never seem to go away, you should visit your doctor. Some symptoms could be signs of an autoimmune disease. These symptoms include:

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Immune System: Parts & Common Problems - Cleveland Clinic

Your immune system is your bodys defense againstinfections and other harmfulinvaders. Without it, you would constantly get sick frombacteria or viruses.

Your immune system is made up of special cells, tissues, and organs that work together to protect you.

The lymph, or lymphatic, system is a major part of the immune system. It's a network of lymph nodes and vessels. Lymphatic vessels are thin tubes that branch, like blood vessels,throughout the body. They carry a clear fluid called lymph. Lymph contains tissue fluid, waste products, and immune system cells. Lymph nodes are small, bean-shaped clumps of immune system cells that are connected by lymphatic vessels. They contain white blood cells that trap viruses, bacteria, and other invaders, including cancer cells.

White blood cells are the cells of the immune system. They are made in one of your lymph organs, the bone marrow. Other lymph organs include thespleen and thymus.

When your immune system doesn't work the way it should, it is called an immune system disorder. You may:

Beborn with a weak immune system. This is called primary immune deficiency.

Get a disease that weakens your immune system. This is called acquired immune deficiency.

Have animmune system that is too active.This may happen with an allergic reaction.

Have animmune system thatturns against you. This is called autoimmune disease.

Here are some common examples:

Severe combined immunodeficiency (SCID).This is an example of an immune deficiency that is present at birth.Children arein constant danger of infections from bacteria, viruses, and fungi. This disorder is sometimes called bubble boy disease.In the 1970s, a boyhad to live in a sterile environment inside a plastic bubble. Children with SCID are missing important white blood cells.

Temporary acquired immune deficiencies.Yourimmune system can be weakened by certain medicines, for example. This canhappen to peopleon chemotherapy or other drugs used to treat cancer. It can also happen to people followingorgan transplants who take medicine to prevent organ rejection.Also, infections like the flu virus, mono (mononucleosis), and measlescan weaken the immune system for a brief time. Your immune system can also be weakened by smoking, alcohol,and poor nutrition.

AIDS.HIV, which causes AIDS, is an acquired viralinfection that destroys important white blood cells and weakens the immune system.People withHIV/AIDS become seriously ill with infections that most peoplecan fight off. These infections are called opportunistic infections because they take advantage of weak immune systems.

If you are born with certain genes, your immune system may react to substances inthe environment that are normally harmless. These substances are called allergens. Having an allergic reaction is the most common example of an overactive immune system. Dust, mold, pollen,and foods are examples of allergens.

Some conditions caused by an overactive immune system are:

Asthma.The response in your lungs can cause coughing, wheezing, and trouble breathing. Asthma can be triggered by common allergens like dust or pollenor by an irritant like tobacco smoke.

Eczema.An allergen causes an itchy rash known as atopic dermatitis.

Allergic rhinitis.Sneezing, a runny nose, sniffling, and swelling of your nasal passages from indoor allergens like dust and pets or outdoor allergens like pollens or molds.

Inautoimmune diseases, the body attacks normal, healthy tissues. The cause is unknown. It is probably a combination of a persons genes and something in the environmentthat triggers those genes.

Three common autoimmune diseases are:

Type 1 diabetes.The immune systemattacksthe cells inthe pancreas that make insulin. Insulin removes sugar fromthe blood to use as energy.

Rheumatoid arthritis.Thistype of arthritiscauses swelling and deformities of the joints. An auto-antibody called rheumatoid factoris in the blood of some people with rheumatoid arthritis.

Lupus.This disease that attacks body tissues, including thelungs, kidneys, and skin. Many types of auto-antibodies are found in the blood ofpeople with lupus.

No one knows exactly what causes autoimmune diseases, but many factors seem to be involved. If you have an immune system disorder, learn as much as you can aboutit. And work closely with yourhealthcare providersto manage it.

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Disorders of the Immune System | Johns Hopkins Medicine

What is biotechnology?

Biotechnology is the use of biology to develop new products, methods and organisms intended to improve human health and society. Biotechnology, often referred to as biotech, has existed since the beginning of civilization with the domestication of plants, animals and the discovery of fermentation.

Early applications of biotech led to the development of products such as bread and vaccines. However, the discipline has evolved significantly over the last century in ways that manipulate the genetic structures and biomolecular processes of living organisms. The modern practice of biotechnology draws from various disciplines of science and technology, including the following:

This approach has resulted in innovations and breakthroughs in the following areas:

Modern applications of biotechnology work most often through genetic engineering, which is also known as recombinant DNA technology. Genetic engineering works by modifying or interacting with the genetic cell structures. Every cell in an animal or plant contains genes that produce proteins. It's those proteins that determine the characteristics of the organism.

By modifying or interacting with genes, scientists can strengthen the characteristics of an organism or create an entirely new organism. These modified and new organisms may be beneficial to humans, such as crops with higher yields or increased resistance to drought. Genetic engineering also enables the genetic modification and cloning of animals, two controversial developments.

Biotechnology began at least 6,000 years ago with the agricultural revolution. This early era was characterized by exploiting living organisms in their natural forms or modifying their genetic makeup through selective breeding.

Around the same time, humans learned to harness the biological process of fermentation to produce bread, alcohol and cheese. People also began changing the genetic makeup of domesticated plants and animals through selective breeding.

Selective breeding works by breeding parents with desirable characteristics to express or eliminate certain genetic characteristics in their offspring. Over time, species that are selectively bred evolve to be different from their wild ancestors. For instance, during the agricultural revolution, wheat was selectively bred to stay on its stem when harvested instead of falling to the ground like wild wheat. Dogs were selectively bred to be more docile than their wolf ancestors.

However, biotech methods such as selective breeding can take a long time to show changes in species. Biotechnology remained limited to these slow, agricultural methods until the 19th century when biologist Gregor Mendel discovered the basic principles of heredity and genetics.

Also, during that era, scientists Louis Pasteur and Joseph Lister discovered the microbial processes of fermentation. This laid the foundation for biotechnology industries where scientists interact more directly with the molecular and genetic processes of organisms.

Based on the work of these scientists, genetic engineering was developed in 1973. This method is the foundation of modern biotechnology practices and recent advances. It enabled the first direct manipulation of plant and animal genomes, which is the complete set of genes present in a cell.

Over the last 100 hundred years or so, biotechnology emerged with the following discoveries and advancements:

1919. Hungarian scientist Karl Ereky coins the term biotechnology.

1928. Alexander Fleming discovers penicillin, the first true antibiotic.

1943. Oswald Avery proves DNA carries genetic information.

1953. James Watson and Francis Crick discover the double helix structure of DNA.

1960s. Insulin is synthesized to fight diabetes, and vaccines for measles, mumps and rubella are developed.

1969. The first synthesis of an enzyme in vitro, or outside the body, is conducted.

1973. Herbert Boyer and Stanley Cohen develop genetic engineering with the first insertion of DNA from one bacteria into another.

1980s. The first biotech drugs to treat cancer are developed.

1890. The United States Supreme Court rules that a "live human-made microorganism is patentable subject matter," meaning GMOs can be intellectual property.

1982. A biotech-developed form of insulin becomes the first genetically engineered product approved by the U.S. Food and Drug Administration (FDA).

1983. The first genetically modified plant is introduced.

1993. GMOs are introduced into agriculture with the FDA approval of growth hormones that produce more milk in cows.

1997. The first mammal is cloned.

1998. The first draft of the Human Genome Project is created, giving scientists access to over 30,000 human genes and facilitating research on treatment of diseases such as cancer and Alzheimer's.

2010. The first synthetic cell is created.

2013. The first bionic eye is created.

2020. MRNA vaccine and monoclonal antibody technology is used to treat the SARS-CoV-2 virus.

The science of biotechnology is broken down into subdisciplines that are color-coded based on common uses and applications.

The use and commercialization of modern biotechnology often fall into four main fields: environment, medicine, industry and agriculture.

The aim of environmental biotechnology is to develop sustainable environmental practices that reduce pollution and waste. The following are examples of environmental biotech:

Medical biotechnology, also known as biopharma, aims to fight and prevent disease and improve healthcare. Biotechnology and biomedical research are the basis of the modern pharmaceutical industry. Uses include the following:

Industrial biotechnology involves using microorganisms to produce industrial goods. Examples include the following:

Agricultural biotechnology genetically engineers plants and animals to produce more efficient agriculture, increase nutritional value and reduce food insecurity. Some examples of agricultural biotechnology are the following:

Biotechnology production offers a variety of advantages and solutions to critical problems. The main ones are the following:

Biotechnology also comes with disadvantages and misuse. The main disadvantages include the following:

Concerns about biotechnology's disadvantages have led to efforts to enact legislation restricting or banning certain processes or programs, such as human cloning, GMOs and embryonic stem-cell research.

Biotechnology is critical to environmentally sound advancements in agriculture. Learn more about how technology like artificial intelligence (AI) is improving the food industry.

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What is Biotechnology? Definition, Types and Applications | TechTarget

Where Does Novavax Inc (NVAX) Stock Fall in the Biotechnology Field After It Is Lower By -12.99% This Week?  InvestorsObserver

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Where Does Novavax Inc (NVAX) Stock Fall in the Biotechnology Field After It Is Lower By -12.99% This Week? - InvestorsObserver

Should Biotechnology Stock Outlook Therapeutics Inc (OTLK) Be in Your Portfolio Thursday?  InvestorsObserver

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Should Biotechnology Stock Outlook Therapeutics Inc (OTLK) Be in Your Portfolio Thursday? - InvestorsObserver

SANA BIOTECHNOLOGY, INC. : Results of Operations and Financial Condition, Financial Statements and Exhibits (form 8-K)  Marketscreener.com

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SANA BIOTECHNOLOGY, INC. : Results of Operations and Financial Condition, Financial Statements and Exhibits (form 8-K) - Marketscreener.com

Genetic therapies aim to treat or cure conditions by correcting problems in your DNA. Your DNA, including specific genes, contains instructions for making proteins that are essential for good health. Mutations, or changes in your DNA, can lead to proteins that do not work properly or that are missing altogether. These changes can cause genetic, or inherited, disorders such as cystic fibrosis, thalassemia, hemophilia, and sickle cell disease.

Genetic therapies are approaches that treat genetic disorders by providing new DNA to certain cells or correcting the DNA. Gene transfer approaches, also called gene addition, restore the missing function of a faulty or missing gene by adding a new gene to affected cells. The new gene may be a normal version of the faulty gene or a different gene that bypasses the problem and improves the way the cell works.

Genome editing is a newer approach that allows precise correction or other targeted changes to the DNA in cells to restore a cells function. Genome editing can:

Gene transfer or genome editing treatments can directly modify the cells in your body, or your cells can be collected and treated outside of your body and then returned to you. For example, a doctor can remove immune system cells, cells that are part of your bodys natural defense system, or bone marrow cells from your body, modify their DNA, and then re-introduce them to your body.

The only genetic therapies that are currently approved by the U.S. Food and Drug Administration (FDA) are for a rare inherited eye condition, as well as certain types of cancer. Genetic therapies that are in development could treat or cure other inherited disorders; treat other cancers; or treat infections, including HIV.

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Genetic Therapies - What Are Genetic Therapies? | NHLBI, NIH

Espaol

The genes in your bodys cells play a key role in your health. Indeed, a defective gene or genes can make you sick.

Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition.

This research is paying off, as advancements in science and technology today are changing the way we define disease, develop drugs, and prescribe treatments.

The U.S. Food and Drug Administration has approved multiple gene therapy products for cancer and rare disease indications.

Genes and cells are intimately related. Within the cells of our bodies, there are thousands of genes that provide the information to produce specific proteins that help make up the cells. Cells are the basic building blocks of all living things; the human body is composed of trillions of them.

The genes provide the information that makes different cells do different things. Groups of many cells make up the tissues and organs of the body, including muscles, bones, and blood. The tissues and organs in turn support all our bodys functions.

Sometimes the whole or part of a gene is defective or missing from birth. This is typically referred to as a genetically inherited mutation.

In addition, healthy genes can change (mutate) over the course of our lives. These acquired mutations can be caused by environmental exposures. The good news is that most of these genetic changes (mutations) do not cause disease. But some inherited and acquired mutations can cause developmental disorders, neurological diseases, and cancer.

Depending on what is wrong, scientists can do one of several things in gene therapy:

To insert new genes directly into cells, scientists use a vehicle called a vector. Vectors are genetically engineered to deliver the necessary genes for treating the disease.

Vectors need to be able to efficiently deliver genetic material into cells, and there are different kinds of vectors. Viruses are currently the most commonly used vectors in gene therapies because they have a natural ability to deliver genetic material into cells. Before a virus can be used to carry therapeutic genes into human cells, it is modified to remove its ability to cause infectious disease.

Gene therapy can be used to modify cells inside or outside the body.When a gene therapy is used to modify cells inside the body, a doctor will inject the vector carrying the gene directly into the patient.

When gene therapy is used to modify cells outside the body, doctors take blood, bone marrow, or another tissue, and separate out specific cell types in the lab. The vector containing the desired gene is introduced into these cells. The cells are later injected into the patient, where the new gene is used to produce the desired effect.

Before a gene therapy can be marketed for use in humans, the product must be tested in clinical studies for safety and effectiveness so FDA scientists can consider whether the risks of the therapy are acceptable considering the potential benefits.

The scientific field for gene therapy products is fast-paced and rapidly evolving ushering in a new approach to the treatment of vision loss, cancer, and other serious and rare diseases. As scientists continue to make great strides in this therapy, the FDA is committed to helping speed up development by interacting with those developing products and through prompt review of groundbreaking treatments that have the potential to save lives.

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How Gene Therapy Can Cure or Treat Diseases | FDA

India can lead the One Earth, One Health vision with holistic policy-making environment: Mansukh Manda..  ETHealthWorld

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India can lead the One Earth, One Health vision with holistic policy-making environment: Mansukh Manda.. - ETHealthWorld

By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative medical products. Products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.

The FDAs November 2017 regenerative medicine policy framework was developed to help facilitate and support innovation in the area of regenerative medicine therapies. As part of this framework, we encourage sponsors to take advantage of ongoing expedited programs that might be available to them, including Regenerative Medicine Advanced Therapy, breakthrough therapy, and fast track designations, to support product development and licensure.

The framework also outlines the agencys intent to exercise enforcement discretion with respect to the FDAs investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products until November 2020, which was later extended through May 2021. This compliance and enforcement discretion policy gives manufacturers time to determine if certain requirements apply to their products, and if an application is needed, to prepare and submit the appropriate application to the FDA.

We are now reaffirming the timing of the end of the compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies. The period during which the FDA intends to exercise enforcement discretion with respect to the IND and premarket approval requirements for certain HCT/Ps ends on May 31, 2021, and will not be extended further.

Since November 2017, the FDA has worked with product developers to help them determine if they need to submit an IND or marketing application and, if so, how they should submit their application to the FDA. The FDA developed programs that provide opportunities for engagement between HCT/P manufacturers and the agency, including the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP). TRIP helped manufacturers of HCT/Ps, including stakeholders that market HCT/Ps to physicians or patients, obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated. TRIP was a temporary program of the TRG. The TRIP began in June 2019 and was extended twice. It recently ended on March 31, 2021.

Despite all of the FDAs efforts to engage industry, there continues to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions. Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements. The wide extent of the marketing of such unapproved products is evidenced by their inappropriate advertisement in various media and by the number of consumer complaints about them submitted to the FDA.

These regenerative medicine products are not without risk and are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they havent been adequately studied in clinical trials. Weve said previously and want to reiterate here there is no room for manufacturers, clinics, or health care practitioners to place patients at risk through products that violate the law, including by not having an IND in effect or an approved biologics license. We will continue to take action regarding unlawfully marketed products. Our oversight of cellular and related products has included taking compliance actions, including numerous warning and untitled letters, and pursuing enforcement action for serious violations of the law.

Since December 2019, the agency has issued more than 350 letters to manufacturers, clinics, and health care providers, noting that it has come to our attention that they may be offering unapproved regenerative medicine products and reiterating the FDAs compliance and enforcement policy.

We encourage the public and patients who are considering treatment with regenerative medicine products to work with their health care providers to learn about the treatment being offered. Ask questions and understand the potential risks of treatment with unapproved products. It is critical to only seek treatment using legally marketed products, or, for unapproved products, to enroll in clinical trials under FDA oversight. The public can visit the FDAs website to find out if a particular regenerative medicine product is approved.

The FDA remains committed to helping advance the development of safe and effective regenerative medicine products, including stem cell-based products, to benefit individuals in need. We look forward to working with those who share this goal.

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Advancing Safe and Effective Regenerative Medicine Products

Active Wound Care Market Rising demand for Skin Substitutes to boost the industry (2023-2033) | CAGR of 5.5%  EIN News

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Active Wound Care Market Rising demand for Skin Substitutes to boost the industry (2023-2033) | CAGR of 5.5% - EIN News

Veterinary Orthopedic Implants Market is estimated to be 421.3 Million by 2029 with a CAGR of 5.3% - By PMI  EIN News

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Veterinary Orthopedic Implants Market is estimated to be 421.3 Million by 2029 with a CAGR of 5.3% - By PMI - EIN News

OverviewWhat is Diabetes?What is diabetes?

Diabetes is a condition that happens when your blood sugar (glucose) is too high. It develops when your pancreas doesnt make enough insulin or any at all, or when your body isnt responding to the effects of insulin properly. Diabetes affects people of all ages. Most forms of diabetes are chronic (lifelong), and all forms are manageable with medications and/or lifestyle changes.

Glucose (sugar) mainly comes from carbohydrates in your food and drinks. Its your bodys go-to source of energy. Your blood carries glucose to all your bodys cells to use for energy.

When glucose is in your bloodstream, it needs help a key to reach its final destination. This key is insulin (a hormone). If your pancreas isnt making enough insulin or your body isnt using it properly, glucose builds up in your bloodstream, causing high blood sugar (hyperglycemia).

Over time, having consistently high blood glucose can cause health problems, such as heart disease, nerve damage and eye issues.

The technical name for diabetes is diabetes mellitus. Another condition shares the term diabetes diabetes insipidus but theyre distinct. They share the name diabetes because they both cause increased thirst and frequent urination. Diabetes insipidus is much rarer than diabetes mellitus.

There are several types of diabetes. The most common forms include:

Other types of diabetes include:

Diabetes is common. Approximately 37.3 million people in the United States have diabetes, which is about 11% of the population. Type 2 diabetes is the most common form, representing 90% to 95% of all diabetes cases.

About 537 million adults across the world have diabetes. Experts predict this number will rise to 643 million by 2030 and 783 million by 2045.

Symptoms of diabetes include:

Its important to talk to your healthcare provider if you or your child has these symptoms.

Additional details about symptoms per type of diabetes include:

Too much glucose circulating in your bloodstream causes diabetes, regardless of the type. However, the reason why your blood glucose levels are high differs depending on the type of diabetes.

Causes of diabetes include:

Long-term use of certain medications can also lead to Type 2 diabetes, including HIV/AIDS medications and corticosteroids.

Diabetes can lead to acute (sudden and severe) and long-term complications mainly due to extreme or prolonged high blood sugar levels.

Acute diabetes complications that can be life-threatening include:

Blood glucose levels that remain high for too long can damage your bodys tissues and organs. This is mainly due to damage to your blood vessels and nerves, which support your bodys tissues.

Cardiovascular (heart and blood vessel) issues are the most common type of long-term diabetes complication. They include:

Other diabetes complications include:

Living with diabetes can also affect your mental health. People with diabetes are two to three times more likely to have depression than people without diabetes.

Healthcare providers diagnose diabetes by checking your glucose level in a blood test. Three tests can measure your blood glucose level:

To screen for and diagnose gestational diabetes, providers order an oral glucose tolerance test.

The following test results typically indicate if you dont have diabetes, have prediabetes or have diabetes. These values may vary slightly. In addition, healthcare providers rely on more than one test to diagnose diabetes.

Diabetes is a complex condition, so its management involves several strategies. In addition, diabetes affects everyone differently, so management plans are highly individualized.

The four main aspects of managing diabetes include:

Due to the increased risk for heart disease, its also important to maintain a healthy:

You cant prevent autoimmune and genetic forms of diabetes. But there are some steps you can take to lower your risk for developing prediabetes, Type 2 diabetes and gestational diabetes, including:

Its important to note that there are some diabetes risk factors you cant change, such as your genetics/family history, age and race. Know that Type 2 diabetes is a complex condition that involves many contributing factors.

The prognosis (outlook) for diabetes varies greatly depending on several factors, including:

Chronic high blood sugar can cause severe complications, which are usually irreversible. Several studies have shown that untreated chronic high blood sugar shortens your lifespan and worsens your quality of life.

In the United States, diabetes is the eighth leading cause of death. A large number of people with diabetes will die from a heart attack or stroke.

However, its important to know that you can live a healthy life with diabetes. The following are key to a better prognosis:

Studies show that people with diabetes may be able to reduce their risk of complications by consistently keeping their A1c levels below 7%.

If you havent been diagnosed with diabetes, you should see a healthcare provider if you have any symptoms of diabetes, such as increased thirst and frequent urination.

If you have diabetes, you should see your provider who helps you manage diabetes (such as an endocrinologist) regularly.

A note from Cleveland Clinic

Being diagnosed with diabetes is a life-changing event, but it doesnt mean you cant live a happy and healthy life. Managing diabetes involves consistent care and diligence. While itll likely be very overwhelming at first, over time youll get a better grasp on managing the condition and being in tune with your body.

Be sure to see your healthcare provider(s) regularly. Managing diabetes involves a team effort youll want medical professionals, friends and family on your side. Dont be afraid to reach out to them if you need help.

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Diabetes: What It Is, Causes, Symptoms, Treatment & Types

A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors  Economic Times

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A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors - Economic Times

Regenerative Therapies Market is Set to Grow at a CAGR of 8.7% by 2033, Propelled by Advancements in  EIN News

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Regenerative Therapies Market is Set to Grow at a CAGR of 8.7% by 2033, Propelled by Advancements in - EIN News

Gene Therapy Market Size (USD 46.5 Bn by 2030): A Growing Industry and Its Impact on Healthcare Systems  EIN News

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Gene Therapy Market Size (USD 46.5 Bn by 2030): A Growing Industry and Its Impact on Healthcare Systems - EIN News

Genetic engineering, also calledgenetic modification, is the direct manipulation of an organismsgenomeusing biotechnology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novelorganisms. Read important facts about Genetic Engineering in this article for the IAS Exam.

NewDNAmay be inserted in the host genome by first isolating and copying the genetic material of interest usingmolecular cloningmethods to generate a DNA sequence, or by synthesizing the DNA and then inserting this construct into the host organism.Genesmay be removed, or knocked out, using anuclease.Gene targetingis a different technique that useshomologous recombinationto change an endogenous gene and can be used to delete a gene, removeexons, add a gene, or introducepoint mutations.

Aspirants reading, GEAC can also refer to topics lined below:

Medicine, research, industry and agriculture are a few sectors where genetic engineering applies. It can be used on various plants, animals and microorganisms. The first microorganism to be genetically modified is bacteria.

Genetic Engineering Appraisal Committee (GEAC) is the biotech regulator in India. It is created under the Ministry of Environment and Forests. Read more about GEAC in the linked article.

There are five bodies that are authorized to handle rules noted underEnvironment Protection Act 1986 Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989. These are:

Soybean-Herbicide tolerance,Canola-Altered fatty acid composition,Plum-Virus resistance,Corn-Insect resistance

Pros:Tackling and Defeating Diseases,Getting Rid of All Illnesses in Young and Unborn Children,Potential to Live Longer,Produce New Foods,Faster Growth in Animals and Plants,Pest and Disease Resistance.Cons:May Lead to Genetic Defects,Limits Genetic Diversity,Reduced Nutritional Value,Risky Pathogens,Negative Side Effects

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Genetic Engineering - Meaning, Applications, Advantages and Challenges ...