Category Archives: Regenerative Medicine

Instead of trying to compensate for failing organs, what if we could readily replace diseased or injured body parts with brand-new versions made in the lab? Researchers working in the field of regenerative medicine have already made amazing progress, creating artificial organs and miniature labs-on-a-chip. The return on investment for this area of research is expected to be dramatic: better understanding of how diseases develop and spread, accurate screens for testing new drugs, and cell-based therapies for diabetes, arthritis, Parkinsons disease, and many other conditions that affect millions of Americans. NIH researchers have already created miniature hearts that beat rhythmically in a culture dish and contain all the different cell types that make up a human heart. Scientists have also developed a lung-on-a-chip. When intermittent suction is applied, the cells in this thumb-sized device flex and stretch rhythmically just as they do in our lungs when we breathe. For individuals with kidney failure, the potential of using their own skin cells to build a new kidney might now be within reach given years of hard work and the necessary research investment.

Each year, NIH research funding can be expected to generate more than 100 new inventions..

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This page last reviewed on February 11, 2020

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Regenerative Medicine - National Institutes of Health (NIH)

June 3, 2021

The US Food and Drug Administration (FDA) regulates regenerative medicine products. There continues to be broad marketing of unapproved products considered regenerative medicine therapies that are intended for the treatment or cure of a wide range of diseases or medical conditions. These products require FDA licensure/approval to be marketed to consumers. Before approval, these products require FDA oversight in a clinical trial. These unapproved products whether recovered from your own body or another persons body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells1, amniotic fluid, Whartons jelly, ortho-biologics, and exosomes. FDA has received reports of blindness, tumor formation, infections, and more, detailed below, due to the use of these unapproved products.

If you are being offered any of these products outside of a clinical trial for which FDA has oversight, please contact FDA at ocod@fda.hhs.gov. Additionally, contact FDA if you are considering treatment with any of these products and have questions, or if you have been treated with these products and wish to report any adverse effects or file a complaint. We take these reports seriously and want to hear from you.

If you were hurt or had a bad side effect following treatment with a regenerative medicine product, or a similar product, we also encourage you to report it to the FDAs MedWatch Adverse Event Reporting program. Additional information for patients on reporting adverse events for these products can be found here.

Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally. Likewise, FDA is aware that patients and consumers are being referred to clinicaltrials.gov, or are told that a product is registered with FDA, as a way to suggest that the products being offered are in compliance with FDA laws and regulations. This is often false. The inclusion of a product in the clinicaltrials.gov database or the fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed. If you are considering receiving one of these products, please contact FDA at ocod@fda.hhs.gov.

This web posting reemphasizes the warning to consumers in FDAs July 2020 Consumer Alert:

FDA has repeatedly notified manufacturers, clinics, and health care practitioners of the need for Investigational New Drug applications (INDs) to legally administer these products and to ensure safety measures are in place prior to administration.

These regenerative medicine products have risks but are often illegally 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 under an IND to demonstrate the claims of safety and effectiveness. Safety concerns with any product that is illegally marketed as a regenerative medicine therapy include the following:

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FDA letter to clinics and health care providers offering stem cell or related products to treat a variety of diseases or conditions

Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)

1Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the hematopoietic system) but they are not approved for other uses.

07/09/2021

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Regenerative medicine therapy, including cell therapy, gene therapy, and therapeutic tissue engineering, provides unprecedent potential to treat, modify, reverse, or cure previously intractable diseases, such as cancer and organ failures. This class of therapy has completely changed the paradigm and the trajectory for medical treatment. Broad clinical translation and patient access requires advances in manufacturing technologies and measurements to ensure the safety, quality, and consistency of the therapy and to reduce the cost.

NIST is committed to solving the measurement challenges of this fast-moving sector of the bioeconomy by providing underpinning measurement infrastructure and platform technologies, as well as standards to promote manufacturing innovation, improve supply chain resilience, and support characterization and testing to facilitate regulatory approval.

The NIST Regenerative Medicine program is working closely with the U.S. Food and Drug Administration'sCenter for Biologics Evaluation and Research(FDA/CBER) and the Standards Coordinating Body (SCB) as well as the broader industry to develop global manufacturing and measurement standards underpinned by a robust measurement infrastructure needed to advance product development and translation as directed by Sec. 3036 of the 21st Century Cures Act.

The NIST laboratory programs support this growing industry as well as the broader industry ecosystem by:

NIST has developed a suite of standards and tools for characterizing biological systems and components using advanced measurement science strategies that enable the generation of high-quality data. Some recent examples of NISTs work include:

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Regenerative medicine | NIST

Regenerative medicine represents an amazing step forward in medical research. Not only does it have the potential to one day end donor registries and heal millions of people previously thought un-treatable, but regenerative medicine can do some incredible things already.

The main focus of regenerative medicine is on saving and improving lives. However, how it does that is the cause of much excitement and discussion across the world.

While still in its infancy, regenerative medicine uses special techniques to try and stimulate the bodys natural healing and regeneration processes. This allows your body to work for you, potentially accelerating your recovery from injuries and helping you treat certain conditions or diseases.

To understand how it all works, we should begin by talking about what regeneration is.

In traditional biology, regeneration is understood as the process that some creatures use to restore lost or amputated limbs and other body parts.

One of the most classic examples is the salamander, but planarians (a type of flatworm) and some other creatures have this capability as well. If a salamander loses a leg for almost any reason, it can regenerate a perfectly functional leg on its own. Planarians can regrow their entire body from either side if they are cut in half.

Today, if a human loses a limb, it will not grow back. If we lose an organ, its gone. Imagine if we could trigger controlled regeneration and regrow a healthy organ to replace one that was damaged or diseased. That day may not be as far off as you think.

USC is currently performing research that could change how organs are replaced. Their scientists are working on creating functional, miniature human livers and repairing heart damage, and thats just a start.

Many other universities, hospitals, clinics, and scientists around the world are also researching scientific advances that we never thought possible before regenerative medicine.

Regenerative Medicine Gallery

As the name implies, regenerative medicine actually relies on regeneration to heal patients. This could be from an infusion of regenerative cells or any other method that stimulates the bodys natural regenerative processes.

Cellular therapy is a common example of regenerative medicine that can utilize a simple procedure that only takes a few hours. However, those few hours could potentially result in months or even years of reduced pain and inflammation and increased mobility. This is what makes regenerative medicine and cell therapy so special.

However, thats not the only application of regeneration in regenerative medicine. Recently, doctors have even been able to regenerate entire organs with cellular therapy. The most exciting thing is that this science is only in its infancy, and we can expect even more incredible things to come.

In the future, regenerative medicine may make donor lists unnecessary and provide living, functional transplants made from just a few cells.

Since regenerative medicine relies on regeneration, it requires an attempt to stimulate natural regenerative processes. This can be accomplished in several ways, each with their own uses, and can have different effects on different patients.

A great deal of research has gone into learning more about regenerative medicine. As it has become adopted by hospitals to treat advanced issues, several types of regenerative medicine have emerged as the current leaders in the field.

Lets go over two great examples: cell therapy and PRP.

In cell therapy, regenerative capable cells are injected into the body of a patient. Afterwards, they become other kinds of cells in the body. By using certain types of cells, doctors can even narrow down the kinds of cells they could become.

For instance, if a patient with an injured knee walks into a stem cell clinic, they may sit down for a quick procedure. During the procedure, they may have a very small amount of fatty tissue removed from their abdomen. Cells known as adipose-derived mesenchymal stem cells are removed from this fatty tissue.

One really cool thing about adipose-derived mesenchymal stem cells is that they can infinitely self-replicate. Another interesting thing is that they are considered multipotent, meaning that they could turn into multiple types of cells. So, even though they are from your skin, they could become other helpful cells inside your body.

Since the bodys natural way of regenerating involves replacing old cells with new cells, these stem cells can stimulate a regenerative response inside the body by becoming new cells.

PRP (platelet rich plasma) involves collecting platelets from a patients blood in a similar process. Platelets naturally travel to your injuries and tell the brain to send over the right kind of stem cells.

For a PRP procedure, a patient has blood drawn, and then the platelets are separated out. These platelets are then injected back into you in an attempt to stimulate your bodys natural healing response.

Not only could this promote healing and assist in recovering from injuries, but it can be paired up with cell therapy in an attempt for an even more profound result.

By stimulating the bodys natural regenerative processes, regenerative medicine attempts to replace cells affected by age, injury, disease, and congenital defects. This could potentially allow for the treatment of orthopedic issues, diseases, and many other conditions.

Because of this, regenerative medicine has already become the next frontier in medical science. Researchers and scientists across the globe are working together with doctors to discover new clinical applications for this medical breakthrough.

Getting a regenerative medicine procedure done at Dynamic Stem Cell Therapy is quick and effortless.

It all starts with a conversation to help us better understand your needs and offer a potential solution. If a procedure seems like the best option, we will help you schedule one in our relaxing spa-like environment and cutting edge surgical center.

Your procedure is normally scheduled within a 2 week time frame as you will need to get pre-op instructions and avoid the medications on our restrictions list for that amount of time. We look forward to your visit.

Upon your arrival, necessary paperwork and completion of payment will take place before our one of our registered nurses gets you prepped for your procedure.

Harvesting in the form of phlebotomy or syringe aspirated mini liposuction may be necessary. Cells sometimes need to be extracted, isolated, washed, neutralized and activated before returning them to your body with a simple injection into intra-articulate joints in combination with some infusions.

The entire process is over in as little as 45 minutes to just a few hours. Most patients can return to work later that day and even the next day without issue. Instructions on physical limitations, some medication, and even some dietary restrictions are given to each patient to help expedite the healing process.

We even offer regenerative medicinefinancingfor all of our procedures.

Got questions?Contact usor check out our FAQ for more information about ourstem cell therapy procedure.

Dynamic Stem Cell Therapy employs an incredible staff and a compassionate, world-class doctor that can help you find the right path for your personalized treatment.

Our experienced Las Vegas regenerative medicine clinic offers regenerative medicine procedures including PRP and cell-based therapies for many injuries or conditions.

As with any treatment option, it is important to work with a doctor that develops a customized treatment plan for your unique circumstances. With our talented regenerative medicine doctor and a customized treatment plan, we may be able to get you back to a fuller, more vibrant life.

Since you want to hear good things from other patients at the clinic you choose, be sure to check out our outstanding patient testimonials and reviews.

At Dynamic Stem Cell Therapy in Las Vegas, Nevada, our mission is to ensure you receive the care that you need in a safe and controlled way.

While the world of regenerative medicine might seem overwhelming, its much simpler if you start with an experienced clinic that follows high quality standards and has safe practices.

Contact us today to book a free consultation and well help you discover if regenerative medicine could be the right choice for you.

To get started, you can:

Get in touch with us and youll enjoy a free consultation and expert advice throughout your journey as our patient. Well be your partner for any questions about regenerative medicine including PRP, stem cells, or stem cell therapy.

For more information about the regenerative medicine procedures at our clinic, please check our FAQ here.

We cant wait to hear from you!

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What is Regenerative Medicine? | Stem Cell Therapy Las ...

Date: July 22, 2020

If you were hurt or had a bad side effect following treatment with anything that was supposed to be a regenerative medicine product, including, for example, stem cell products and exosome products, we encourage you to report it to the FDAs MedWatch Adverse Event Reporting program. Additional information for patients on reporting adverse events for these products can be found here.

The US Food and Drug Administration (FDA) has authority to regulate regenerative medicine products, including stem cell products and exosome products. There is a lot of misleading information on the internet about these products, including statements about the conditions they can be used to treat. FDA is concerned that many patients seeking cures and remedies may be misled by information about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk. FDA wants to help consumers be informed about how these products are regulated, and what to look for when considering treatment with one of these products.

Stem cell products are regulated by FDA, and, generally, all stem cell products require FDA approval. Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the hematopoietic system) but they are not approved for other uses.

Exosome products are also regulated by FDA. As a general matter, exosome products intended to treat diseases or conditions in humans require FDA approval. There are currently no FDA-approved exosome products.

Anyone considering the use of anything purported to be a regenerative medicine product, including stem cell products, exosome products, or other widely promoted products such as products derived from adipose tissue (this product is also known as stromal vascular fraction), human umbilical cord blood, Whartons Jelly, or amniotic fluid should know:

FDA has posted information for consumers and patients that discusses the potential risks, and provides advice for people considering the use of these products. Consumers should be cautious of any clinics, including regenerative medicine clinics, or health care providers, including physicians, chiropractors, or nurses, that advertise or offer any of these products. FDA also issued a public safety notificationon exosome products on December 6, 2019.

If you are considering a regenerative medicine product and have questions about how it is regulated (including whether FDA approval is required), whether it is FDA-approved, or what to consider before participating in a clinical trial, we urge you to call (800-835-4709) or email(ocod@fda.hhs.gov) for information.

Healthcare professionals and consumers should report any adverse events related to the use of stem cells, exosomes, or other products purported to be regenerative medicine products to the FDAs MedWatch Adverse Event Reporting program. To report an adverse event online, click here: Report a Problem. Additional information for patients on reporting adverse events associated with stem cells, exosomes, or other products purporting to be regenerative medicine products can be found here. The FDA monitors these reports and takes appropriate action to help ensure the safety of medical products in the U.S. marketplace.

07/22/2020

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Consumer Alert on Regenerative Medicine Products Including ...

Regenerative medicine is a new and developing field that aims to restore function in diseased or aged tissues through either revitalizing existing cells, or transplanting new cells. Revitalization could occur through adding powerful growth factors to the body, or modulating the immune system in a way that enhances cell survival and function.

Stem cells are of great interest to regenerative medicine. They lie deep within most tissues of the adult body, but are often difficult to manipulate or expand outside the body. Stem cells in the bone marrow are responsible for blood production and play a major role in our immune defense system. Stem cells may lie at the heart of some cancers and their biology may lead to interesting new approaches to reducing tumor growth. Stem cells also reside in the adult heart and can be manipulated and grown outside the bodythen transplanted back into the same patient. Embryonic stem cells can be isolated from human embryos (hES cells) and expanded to enormous numbers in the culture dish while remaining pluripotentcapable of generating all tissues of the human body.

Very recently, stem cells from the adult human body have been reprogrammed back to an embryonic stem cell state. These induced pluripotent stem (iPS) cells are important for regenerative medicine as they can be derived from a single patient, turned into any tissue of the body, and then used as a source of autologous cells for repair, thus avoiding immune rejection issues.

Furthermore, the use of iPS cells is not burdened with the ethical issues associated with the collection and destruction of human embryos. Finally, iPS cells derived from patients with specific diseases may be used as novel and important models of human disorders.

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About Us - Regenerative Medicine Institute | Cedars-Sinai

Regenerative medicine is a relatively new field of study that treats injuries and diseases by harnessing the bodys own regenerative capabilities.

Encompassinga broad range of scientific disciplines (from molecular biology andgenetics to immunology andbiochemistry), regenerative medicineresearchgenerally focuses on the following keyprinciples:

Human adults already have some regenerative capabilities. For example, the liveris able grown back to its original size if part of it has been lost to injury or disease. Our skin is another part of our body that is able to renew and repair itself.

Some tissues and organs do not have that ability butscientists believe that they could enablethem to do so. To be able to do this they need to answer a number of important questions:

Answering these questions is vital because it will garner insight into how stem cells work to repair or replace tissue and organs. Understanding the molecular and cellular mechanisms at play is essential in the development of regenerative medicine.

There are three main ways regenerative medicine could be applied to patients.

Disease or injury may lead to organ failure. The only solution to this is a transplant. In Australia, roughly1,600 peopleare on the transplant waiting list at any one time. The problem is there are not enough donor organs to go around and many people will die before they get a chance at a new life.

One of the goals of regenerative science is to be able to create new body parts from a patients own cells and tissues. This would not only eliminate the demand for organs but also the complications arising from organ rejection.

Embryonic stem cells (which are highly pluripotent that is, capable of becoming just about any type of cell)are derived from the inner cell mass from blastocysts and areresponsible for our growth. This means that the stem cells were able to divide and differentiate into other sorts of cells like nerve cells, muscle cells and blood cells.

When tissue or organs are damaged, they could potentially repair themselves with these pluripotent stem cells;this process could reverse or prevent damage to vital organs. Thisphenomenon already occurs in nature. The zebrafish, a native to South East Asia,canrepair its own heart, even as an adult.

As previously mentioned, stem cells can act as a repair mechanism for tissue or organs that are injured or diseased. One day we could see them introduced as a form of therapy to treat and cure a wide range of diseases and genetic disorders, including type 1 diabetes, Parkinsons disease, Alzheimers disease, dementia, multiple sclerosis, leukaemia, Crohns disease and rheumatoid arthritis.

What makes regenerative medicine such an exciting field is that it holds the potential of regenerating or replacing any damaged tissue and organs in the body, potentially providing thecure for many diseases, injuries and genetic conditions.

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What is regenerative medicine? - Australian Regenerative ...

Welcome to the Department of Regenerative Medicine and Cell Biology. The goal of the department is to apply our knowledge of molecular and cellular biology to understand and reverse human disease. Regenerative medicine is an emerging field that aims to revolutionize the treatment of disease by providing cures rather than treating symptoms. It relies on multidisciplinary approaches that require expertise in diverse areas. Approaches include the use of stem cells to provide limitless supplies of cells for transplant therapy and disease modeling, bioengineering and tissue engineering to generate replacement tissues and organs, and the production of transgenic animals to study the fundamental molecular basis of organ formation and disease. The department has active research programs in tissue fabrication and bioengineering, developmental biology, cardiovascular disease, digestive and liver disease, cancer biology, cell signaling, and drug development. The Department is also heavily involved in biomedical education through the training of medical and graduate students. Regenerative medicine is at a particularly exciting stage, with investigators being poised to make discipline-changing advances of high impact. The field is on the cusp of revolutionizing biomedical science, and as regenerative medicine researchers we are limited only by our imaginations.

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Department of Regenerative Medicine & Cell Biology ...

If you have chronic pain or suffered a traumatic injury, you may dread the thought of surgery. Thats understandable! We have good news you may never have to worry about surgery again. Regenerative medicine has helped many patients to avoid knee replacements, hip replacements, neck surgery, back surgery and other surgical treatments for injuries.

Regenerative medicine allows us to heal damaged tissue instead of cutting it out or replacing it. If you have arthritis consisting of damaged cartilage and ligaments, we can try to repair the damage instead of replacing your knee with a bionic one. The regenerative process helps create new ligaments and cartilage, repairing the damage. Our philosophy is that your body was designed for healing, not surgery. Regenerative medicine allows us to do that.

These state-of-the-art therapies activate your bodys own healing mechanisms. This provides benefits that are safe and long-lasting. Instead of treating pain with drugs, for example, regenerative medicine aims to stimulate growth in affected areas. Individuals can get treatment for rotator cuff tears and ACL tears without requiring invasive surgeries. People who have arthritis can find true relief by regenerating worn tissues instead of constantly relying on strong pain medications.

The first step in regenerative medicine is to harvest the cells or growth factors required for treatment. At National Stem Cell Clinic, we obtain these incredible natural cells from within the patients body, usually from blood proteins, bone marrow, or fatty tissue. This way, you dont have to worry about tissue rejection or ethical dilemmas from embryonic stem cells.

Next, we apply the cells to the part of the body that needs to repair itself. This activates cells at the site of treatment, helping skin tissue to heal more quickly, regenerating cartilage, and restoring tendons.

Youll notice changes in as soon as one week. It will be uncomfortable sometimes. That discomfort is not a side effect its the desired effect. The first few weeks after a treatment may feel like a roller coaster as your body heals. Some days will be better than others.

You should see maximum benefits from the treatment in 5 to 7 weeks, at which point you should have your official post-procedure follow up to determine if any further treatments are needed. In theory, you may need two treatments at the same site, but that is rare. If the pain continues, you may need treatment on another remote, silent source. Remember that everything in the body is connected, so we may need to investigate to find and treat an additional source of your pain.

Prolotherapy goes all the way back to the 1940s. Of course, it has also improved throughout time. Despite the length of time its been around, prolotherapy is quite cutting edge.

Proliferative therapy, now commonly called prolotherapy, involves injecting a solution to damaged areas that promotes healing and regeneration. In the early days, dextrose and sodium morrhuate (derived from cod liver oil) were most commonly used. And dextrose is still in use today!

Dr. Earl Gedney, an osteopathic physician and surgeon in Philadelphia, decided to treat his own injured thumb with a treatment that had previously been used to treat hernia patients. His thumb was so injured he was facing retirement from surgery and was told that no surgical or therapeutic solution existed. Refusing to take that answer, Dr. Gedney treated his injury successfully, to the point that he was able to resume surgery, He published one of the first major articles on prolotherapy in 1937!

From that time, prolotherapy was researched and used in clinical practices all over the U.S. and Canada. Surgery had a lot more risks in those early years than it does today. Unfortunately for prolotherapy advocates, surgery took over as the dominant solution in the 1950s. Anesthesia had become much safer and more consistent, as had use of antibiotics and disinfectants to prohibit post-surgery illness. Surgery became the effective, elegant solution to most problems. That pendulum began to swing back toward non-surgical interventions in the 1980s. What prompted the shift?

Stem cells were discovered in the 1960s by Dr. Derek van der Kooy at the University of Toronto. His discovery of retinal stem cells was used to reverse blindness.

But physicians and researchers thought that there were few sources of stem cells at that time, limited mostly to fetal tissue and cord blood. No one realized that adults have abundant sources of stem cells as well! In the last 20 years, weve discovered that we all have good stem cells all over our bodies, with the highest concentrations residing in belly fat and bone marrow.

Yes! History is witness to that. In our clinic, we have a success rate of greater than 92%.

Regenerative medicine works best when its tailored to the needs of each patient. At National Stem Cell Clinic, we take the time to understand your pain issues and long-term goals, and then we recommend appropriate treatment options. We offer regenerative medicine and therapy for pain at our locations in Houston, TX, and Miami, FL. With the proper treatment, athletes can get back on the field instead of having to give up a lifelong dream. For more information or to schedule an appointment, contact us right away.

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How Does Regenerative Medicine Work? | National Stem Cell ...

The promise of regenerative medicine is truly remarkable. Over the last two decades, significant breakthroughs in understanding within the regenerative medicine and tissue engineering fields have yielded a more intimate understanding of the functioning of human tissue.

In the future, new technologies may deliver islet cells for diabetes, neural regeneration for spinal cord injuries, and more substantial heart repair. In addition, as biology, bioengineering, and medicine continue to converge, the regenerative medicine field may succeed in building three-dimensional organs like hearts, kidneys, or livers.

Traditionally, researchers at The Petit Institute were focused on the replacement of tissues or growing cell-based substitutes outside the body for implantation into the body. However, as the field has evolved over the last decade, researchers have broadened their approach from a focus on tissue engineering to one that includes repair and regeneration.

The Petit Institute has over 40 investigators whose research is focused on the regenerative medicine field. Projects range from creating better techniques for wound repair to peripheral nerve regeneration. In addition, researchers at The Petit Institute are using advanced bioengineering methods to develop technologies that will facilitate the transfer of research in musculoskeletal biology and regenerative medicine for the treatment of wounded soldiers.

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Regenerative Medicine | Research