Monthly Archives: August 2021

What is regenerative medicine?

Regenerative medicine is a new form of medicine that uses artificially processed and cultured cells or tissues to repair, regenerate, and restore certain tissue or organ functions that have been lost due to causes such as illness, accidents, or aging.

Many conditions considered hard to treat or believed to lack effective treatments (e.g., restoring brain functions of patients that have suffered brain damage from ischemic stroke, or motor functions of patients that have lost the use of their legs due to spinal cord injuries sustained in an accident) are expected to be overcome by the power of regenerative medicine in the future.

Regenerative medicine mainly uses human cells to repair and restore functions of tissues and organs. It encompasses a wide range of treatment techniques and approaches ranging from the use of microscopic cells to organ transplants.The primary cells currently being researched for applications in regenerative medicines are somatic stem cells, embryonic stem (ES) cells, and induced pluripotent stem (iPS) cells. Stem cells can differentiate or proliferate into different types of cells, and are believed to be effective in promoting repair and regeneration of tissues or organs that have been damaged due to illness or other causes. Research on regenerative medicine using cells has been underway even before iPS cells were developed.

Professor Shinya Yamanaka, who pioneered iPS cell research, won the Nobel Prize in Physiology or Medicine for his accomplishments in 2012, paving the way for widespread research in regenerative medicine around the world. The Japanese government designated regenerative medicine as a growth industry with the enforcement of the Act on Securing Safety of Regenerative Medicine and the revised Pharmaceutical Act in 2014, marking the start of a countrywide effort to lead the world in the practical application of regenerative medicines.

Various transplants that use cell types created from human stem cells, embryonic stem (ES) cells, or induced pluripotent stem cells (iPS) cells are being planned in Japan.

The human body is said to comprise over 37 trillion individual cells belonging to over 200 cell types. Through a repeated process of cell division and proliferation, what starts out as a single fertilized egg ultimately differentiates into the full range of cells that make up the human body (such as nerve cells, cardiac muscle cells, and liver cells).

The human body is made up of both differentiated cells (somatic cells) and cells that are still differentiating (somatic stem cells). Stem cells are characterized by the capacity to self-renew or differentiate into cells that form specific tissues and organs. Somatic stem cells include hematopoietic stem cells, neural stem cells, and mesenchymal stem cells, which differentiate into a limited range of cells. For example, hematopoietic stem cells, found in large numbers in bone marrow, produce hematopoietic cells such as white blood cells and platelets, but they normally do not differentiate into other cell types.

Embryonic stem (ES) cells can differentiate into a much wider variety of cell types than somatic stem cells. They are believed to have the capacity (at least in theory) to develop into the full range of cells that make up the human body, including cardiac muscle cells, nerve cells, liver cells, and blood cells. However, because ES cells are derived from fertilized eggsin many cases from surplus embryos discarded in infertility treatmentsthe practice of using such cells for regenerative medicine has stirred debate centered on ethical concerns in many countries. In particular, the use of cells derived from aborted fetuses has drawn wide criticism on ethical grounds.

In 2007, Professor Shinya Yamanaka of Kyoto University successfully developed induced pluripotent stem (iPS) cellsa new form of pluripotent cells that is not derived from fertilized eggsfrom human skill cells. iPS cells closely resemble ES cells by virtue of their capacity to differentiate into a wide range of cells, including cardiac muscle cells, nerve cells, liver cells, and blood cells. They offer an advantage over ES cells because they eliminate the ethical concerns. However, iPS cells, like ES cells, can proliferate indefinitely, and issues such as controlling their proliferation capacity will need to be resolved before they can be used in practical applications. iPS cells are an incredible technology with tremendous potential, but it will take some time before they can be put into practical applications.

Regenerative medicine that uses somatic cells (differentiated cells) can only target a limited range of conditions, and development efforts in this field have therefore already reached a mature stage. In contrast, stem cells (which can differentiate into other cells) can be used to target a much broader range of conditions, and are therefore actively being researched around the world.

Among somatic cells, mesenchymal stem cells (MSC), which can be readily isolated and expanded from bone marrow aspirate, are a suitable cell source for regenerative medicine, and they are already used in therapeutic applications.

Among regenerative medicines, SanBio focuses on developing products for the central nervous system that are not effectively treated at the present time. Examples of these diseases include dysfunction associated with: stroke, traumatic brain injury, retinal degeneration (e.g., age-related macular degeneration), spinal cord injury, Parkinsons disease, Alzheimers disease, and others.Our products are intended to restore motor and sensory functions by inducing or promoting the innate, natural regenerative processes of patients physical functions that were lost due to diseases or accidents.

See original here:
Regenerative Medicine | SanBio - Official Site

Leading Edge Care

Regenerative medicine, also called orthobiologic therapy, works to improve the healing of injured muscles, tendons and joints. The hope is that these treatments can offer relief at a level between a more minor cartilage repair procedure and full joint replacement.

The body has a strong ability to heal itself. Two cell factors, MSCs and platelets, assist in tissue restoration and regeneration.

These cellular substances may:

MSCs, previously known as Mesenchymal stem cells, and PRP (platelet-rich plasma) are considered biologic therapy. These substances are derived from the body and are injected into the injured or diseased area, such as an injured muscle, an inflamed tendon or an arthritic joint.

Platelet rich plasma, or PRP, comes from your blood. Platelets are cells in your blood that have a lot of growth factors and anti-inflammatory agents, both of which help your body to heal.

If your body is injured, platelets are naturally delivered to the injury. The platelets will then release the substances that they hold that help encourage tissue repair. Almost all tissue injuries heal using this process.

For PRP, a sample of your blood is taken. The sample is processed to concentrate the platelets together into the plasma (a layer of your blood), which is then injected into the part of your body that needs healing. The procedure is done in an office and takes 20-30 minutes. Talk with your physician about any activities that you shouldnt do after the procedure.

MSCs can turn into multiple types of cells and tissues. If you break a bone, for example, you will need more bone cells in order to heal the fracture. MSCs are sent by your body to the fracture and grow into new bone cells to repair the break. The same process occurs if you tear a muscle or have a cut in your skin. The description is simple, but the actual process within your body is incredibly complicated.

Mesenchymal stem cells are a specific type of cell in your body. They line blood vessels, and the type used for orthobiologic injection therapy can most easily be found in bone marrow, fat, and amniotic fluid. When injected into an injured or diseased joint or tissue, they dont turn into other types of cells. Instead, they send out signals to the body to decrease inflammation, pain, and infection.

To receive MSC therapy, you will go to an office or to a procedure center.

Amniotic products are shipped frozen, thawed just before use, and are injected into the part of the body being treated.

Bone marrow products and adipose-derived (fat-derived) MSCs are taken from your body: bone marrow MSCs from the crest of your pelvic bone and adipose-derived MSCs from your belly or flank. In both cases the area is anesthetized (numbed) and a needle is placed to draw out the tissue.

The bone marrow or adipose tissue is processed to concentrate important cells and factors which are then injected into the part of the body being treated.

Adipose,or fat tissue, gives the highest amount of cells for these purposes that we know of.

Q: Which are better: PRP or MSCs?A: We dont have this answer. Research has shown that both procedures are generally effective regarding accelerated tendon healing and joint pain control.

Q: How many injections are required?A: Scientists are still studying this. Most MSC studies published used a single injection. Many PRP studies are use several injections separated by weeks or a month. Evidence has not shown for certain that multiple injections are better than a single injection yet.

Q: If I have MSCs injected into my arthritic knee, will it grow new cartilage?A: Studies have shown that areas with cartilage damage may heal better when MSCs are injected. However, the effect of orthobiologic injections is thought to be more pain control than regrowing cartilage. In a knee with arthritis, orthobiologic therapy is a potential bridge between knee restoration and a total knee replacement. You can, however, achieve significant pain control for a period of time. If you have a bone-on-bone joint, where all of the cartilage has worn away, it is very unlikely that an injection with MSCs will give you a new layer of cartilage.

Q: How long will the injection last?A: Studies have shown that the pain-controlling effects of some orthobiologic injections may last 1-2 years or longer. However, PRP studies mostly look at 6-12 month follow-up.

Q: How fast will the injection work?A: While the cells go to work immediately, the effects can take 1-2 months before you notice results. The exact amount of time varies by patient and depends on the exact amount and type of damage being treated.

Q: Which MSC preparation is best: BMAC, adipose, or amniotic?A: Scientists are still working to figure this out. For example, PRP has very effective growth factors, cytokines, and proteins, and few if any cells. Fat and bone marrow have more cells, but were not sure yet if more cells means it will work better.

Q: What does research show?A: Orthobiologic products are a hot button concept in medicine today. Orthobiologics are regularly being used in orthopedics, although we do not fully understand their definition or efficacy. However, scientific studies show good pain relief for people with arthritis and some types of tendon problems, plus quicker healing of tendon injuries with PRP and some MSC products. It could be years before we have all the answers.

Q: Are orthobiologic injections covered by insurance? How much does it cost?A: Currently most insurance policies do not cover orthobiologic injections since they are considered investigational. Speak to your physicians office about the price, which varies depending on the product and procedure used. Ask your health savings account advisor to see if these injections qualify.

Q: How do I make an appointment?A: First, you need to have a screening appointment to see if youre a candidate for these orthobiologic injections. The screening appointment may involve x-rays and an MRI. The physician will then determine if orthobiologic injections are right for you. A separate appointment will be scheduled for the actual procedure.

Excerpt from:
Regenerative Medicine | OrthoVirginia

At Mayo Clinic, an integrated team, including stem cell biologists, bioengineers, doctors and scientists, work together and study regenerative medicine. The goal of the team is to treat diseases using novel therapies, such as stem cell therapy and bioengineering. Doctors in transplant medicine and transplant surgery have pioneered the study of regenerative medicine during the past five decades, and doctors continue to study new innovations in transplant medicine and surgery.

In stem cell therapy, or regenerative medicine, researchers study how stem cells may be used to replace, repair, reprogram or renew your diseased cells. Stem cells are able to grow and develop into many different types of cells in your body. Stem cell therapy may use adult cells that have been genetically reprogrammed in the laboratory (induced pluripotent stem cells), your own adult stem cells that have been reprogrammed or developed.

Researchers also study and test how reprogrammed stem cells may be turned into specialized cells that can repair or regenerate cells in your heart, blood, nerves and other parts of your body. These stem cells have the potential to treat many conditions. Stem cells also may be studied to understand how other conditions occur, to develop and test new medications, and for other research.

Researchers across Mayo Clinic, with coordination through the Center for Regenerative Medicine, are discovering, translating and applying stem cell therapy as a potential treatment for cardiovascular diseases, diabetes, degenerative joint conditions, brain and nervous system (neurological) conditions, such as Parkinson's disease, and many other conditions. For example, researchers are studying the possibility of using stem cell therapy to repair or regenerate injured heart tissue to treat many types of cardiovascular diseases, from adult acquired disorders to congenital diseases. Read about regenerative medicine research for hypoplastic left heart syndrome.

Cardiovascular diseases, neurological conditions and diabetes have been extensively studied in stem cell therapy research. They've been studied because the stem cells affected in these conditions have been the same cell types that have been generated in the laboratory from various types of stem cells. Thus, translating stem cell therapy to a potential treatment for people with these conditions may be a realistic goal for the future of transplant medicine and surgery.

Researchers conduct ongoing studies in stem cell therapy. However, research and development of stem cell therapy is unpredictable and depends on many factors, including regulatory guidelines, funding sources and recent successes in stem cell therapy. Mayo Clinic researchers aim to expand research and development of stem cell therapy in the future, while keeping the safety of patients as their primary concern.

Mayo Clinic offers stem cell transplant (bone marrow transplant) for people who've had leukemia, lymphoma or other conditions that have been treated with chemotherapy.

Visit link:
Mayo Clinic Transplant Center - Regenerative medicine

Sanford Health a history of innovating and leading the way in new research.

Something that grabbed the attention of the NFL Alumni Association.

The NFL Alumni Association is a non-profit that looks to support retired NFL athletes and cheerleaders after their initial careers are over.

Because of the strenuous activity put on their bodies, many athletes walk away from the sport with nagging injuries without the option for care. This has led the NFL Alumni to seek out innovators in the world of health care.

Recently, Dr. David Pearce, Sanford Health president for innovation, research and World Clinic, spoke on regenerative medicine at a congressional briefing. His expertise prompted Kyle Richardson and Billy Davis, co-directors of health care initiatives for the NFL Alumni Association, to inquire about regenerative medicine and how it may serve retired athletes.

More: NFL Alumni tour Sanford, discuss regenerative medicine

As Dr. Pearce told Sanford Health News, its a complicated term, but regenerative medicine is essentially about healing. Dr. Pearce explains that regenerative healing takes something from your own body to heal a wound or an injury.

Im going to give you an example: if you cut yourself right now, it heals, right? The components within your body have the ability to heal an injury, such as a cut. If we twist our ankle and we get swelling, our body reacts and heals that injury. Regenerative medicine is about accelerating that healing so, taking a component of your body, and accelerating that healing and making it better.

Not only for retired athletes, this form of therapy could benefit everyone as they age.

As we get older, we start to deteriorate. So, we can harness our own body to maybe take some of those components that would be used to fix an injury to actually slow down the aging process and the wear and tear on joints, partiucularly in orthopedics.

Thats one of the highlighted areas that we are studying right now. As your knees grind away and you get arthritis, regenerative medicine is about taking some of those healing components to help regenerate and slow down that process, to heal those aches and pains, said Dr. Pearce.

Tiffany Facile is a research development partner at Sanford Health, and soon-to-be director of regenerative medicine at Sanford Health.

She says its imperative this medicine develops through the science of clinical trials.

Some common misconceptions are that regenerative medicine therapies are risky. There is some risk to procedures when using autologous or your own cells, but studies that are currently running should reduce the safety concerns.

Dr. Pearce echos Facile, warning of bad actors who offer products which have no regenerative capacity.

He says theres also a misconception associated with these therapies because theyre not approved by the FDA. However, Sanford Healths clinical trials have been approved.

What were doing at Sanford, is were taking those components of the body, working with the FDA and saying, its safe to do this. Our early work in a clinical study has demonstrated safety and efficacy with rotator cuff injuries. Were having remarkable results in terms of treating some of these injuries.

Another misconception revolves around stem cells. Both Facile and Dr. Pearce say regenerative medicine has not yet determined if stem cells in your body have the ability to signal other cells for repair.

We hear about embryonic stem cells and fetal stem cells; we dont do anything with that. First of all, its not very ethical. Secondly, theres no science to show that they can have regenerative capabilities, said Dr. Pearce.

Dr. Pearce says regenerative medicine can be used to heal nagging injuries, whether its for athletes or not.

Right now were taking cells from around the fat of your abdomen region, which is rich in a type of stem cell called adipose derived regenerative cells, and were relocating them to help heal rotator cuff tears, help to heal osteoarthritis in the knee, elbow, wrist, ankle, and hip, he said.

Dr. Pearce says theyre doing this research, under the auspices of what we call a clinical trial, and where we follow patients to hopefully demonstrate safety and efficacy.

Because of the misconceptions surrounding this form of medicine, we have to do this right, because its not a regulated industry just yet. The food and drug administration oversees what were doing with respect to that.

We know that we can help heal damaged heart cells. We know we can help healing cells that have been damaged by a stroke. Were already taking the next step in working on those protocols where we can do some trials and look to see if we can heal other injuries in the body. These cells have the ability to heal anything in the body, if directed in the right way, said Dr. Pearce.

Dr. Pearce says Sanford Health is the first health system in the nation to get approval for the use of regenerative medicine in treating orthopedic injuries.

Were hoping to be a leader not just in the Midwest, were hoping to be a leader nationally, where we can teach other health systems how to administer these treatments by either going there and training people, or us becoming really a hub for that.

As for the future of regenerative medicine, Dr. Pearce says it could have an impact in how quickly athletes recover from injuries.

I think for athletes that return to play, this will have a huge impact in terms of how we can help people turn around. More importantly, as they retire, we know theres a lot of grinding and wear and tear on their bodies. Well be able to manage that much more appropriately, said Dr. Pearce.

This form of medicine can also help non-athletes manage any nagging aches and pains.

For those whove got some aches and pains here and there, well be able to use this to really alleviate some of the pain and aches we have, and manage that much better.

Posted In Innovations, Orthopedics, Research, Specialty Care, Sports Medicine, World Clinic

See the original post:
What is regenerative medicine? - Sanford Health News

Full Article

Regenerative medicine, the application of treatments developed to replace tissues damaged by injury or disease. These treatments may involve the use of biochemical techniques to induce tissue regeneration directly at the site of damage or the use of transplantation techniques employing differentiated cells or stem cells, either alone or as part of a bioartificial tissue. Bioartificial tissues are made by seeding cells onto natural or biomimetic scaffolds (see tissue engineering). Natural scaffolds are the total extracellular matrixes (ECMs) of decellularized tissues or organs. In contrast, biomimetic scaffolds may be composed of natural materials, such as collagen or proteoglycans (proteins with long chains of carbohydrate), or built from artificial materials, such as metals, ceramics, or polyester polymers. Cells used for transplants and bioartificial tissues are almost always autogeneic (self) to avoid rejection by the patients immune system. The use of allogeneic (nonself) cells carries a high risk of immune rejection and therefore requires tissue matching between donor and recipient and involves the administration of immunosuppressive drugs.

A variety of autogeneic and allogeneic cell and bioartificial tissue transplantations have been performed. Examples of autogeneic transplants using differentiated cells include blood transfusion with frozen stores of the patients own blood and repair of the articular cartilage of the knee with the patients own articular chondrocytes (cartilage cells) that have been expanded in vitro (amplified in number using cell culture techniques in a laboratory). An example of a tissue that has been generated for autogeneic transplant is the human mandible (lower jaw). Functional bioartificial mandibles are made by seeding autogeneic bone marrow cells onto a titanium mesh scaffold loaded with bovine bone matrix, a type of extracellular matrix that has proved valuable in regenerative medicine for its ability to promote cell adhesion and proliferation in transplantable bone tissues. Functional bioartificial bladders also have been successfully implanted into patients. Bioartificial bladders are made by seeding a biodegradable polyester scaffold with autogeneic urinary epithelial cells and smooth muscle cells.

Another example of a tissue used successfully in an autogeneic transplant is a bioartificial bronchus, which was generated to replace damaged tissue in a patient affected by tuberculosis. The bioartificial bronchus was constructed from an ECM scaffold of a section of bronchial tissue taken from a donor cadaver. Differentiated epithelial cells isolated from the patient and chondrocytes derived from mesenchymal stem cells collected from the patients bone marrow were seeded onto the scaffold.

There are few clinical examples of allogeneic cell and bioartificial tissue transplants. The two most common allogeneic transplants are blood-group-matched blood transfusion and bone marrow transplant. Allogeneic bone marrow transplants are often performed following high-dose chemotherapy, which is used to destroy all the cells in the hematopoietic system in order to ensure that all cancer-causing cells are killed. (The hematopoietic system is contained within the bone marrow and is responsible for generating all the cells of the blood and immune system.) This type of bone marrow transplant is associated with a high risk of graft-versus-host disease, in which the donor marrow cells attack the recipients tissues. Another type of allogeneic transplant involves the islets of Langerhans, which contain the insulin-producing cells of the body. This type of tissue can be transplanted from cadavers to patients with diabetes mellitus, but recipients require immunosuppression therapy to survive.

Cell transplant experiments with paralyzed mice, pigs, and nonhuman primates demonstrated that Schwann cells (the myelin-producing cells that insulate nerve axons) injected into acutely injured spinal cord tissue could restore about 70 percent of the tissues functional capacity, thereby partially reversing paralysis.

Studies on experimental animals are aimed at understanding ways in which autogeneic or allogeneic adult stem cells can be used to regenerate damaged cardiovascular, neural, and musculoskeletal tissues in humans. Among adult stem cells that have shown promise in this area are satellite cells, which occur in skeletal muscle fibres in animals and humans. When injected into mice affected by dystrophy, a condition characterized by the progressive degeneration of muscle tissue, satellite cells stimulate the regeneration of normal muscle fibres. Ulcerative colitis in mice was treated successfully with intestinal organoids (organlike tissues) derived from adult stem cells of the large intestine. When introduced into the colon, the organoids attached to damaged tissue and generated a normal-appearing intestinal lining.

In many cases, however, adult stem cells such as satellite cells have not been easily harvested from their native tissues, and they have been difficult to culture in the laboratory. In contrast, embryonic stem cells (ESCs) can be harvested once and cultured indefinitely. Moreover, ESCs are pluripotent, meaning that they can be directed to differentiate into any cell type, which makes them an ideal cell source for regenerative medicine.

Studies of animal ESC derivatives have demonstrated that these cells are capable of regenerating tissues of the central nervous system, heart, skeletal muscle, and pancreas. Derivatives of human ESCs used in animal models have produced similar results. For example, cardiac stem cells from heart-failure patients were engineered to express a protein (Pim-1) that promotes cell survival and proliferation. When these cells were injected into mice that had experienced myocardial infarction (heart attack), the cells were found to enhance the repair of injured heart muscle tissue. Likewise, heart muscle cells (cardiomyocytes) derived from human ESCs improved the function of injured heart muscle tissue in guinea pigs.

Derivatives of human ESCs are likely to produce similar results in humans, although these cells have not been used clinically and could be subject to immune rejection by recipients. The question of immune rejection was bypassed by the discovery in 2007 that adult somatic cells (e.g., skin and liver cells) can be converted to ESCs. This is accomplished by transfecting (infecting) the adult cells with viral vectors carrying genes that encode transcription factor proteins capable of reprogramming the adult cells into pluripotent stem cells. Examples of these factors include Oct-4 (octamer 4), Sox-2 (sex-determining region Y box 2), Klf-4 (Kruppel-like factor 4), and Nanog. Reprogrammed adult cells, known as induced pluripotent stem (iPS) cells, are potential autogeneic sources for cell transplantation and bioartificial tissue construction. Such cells have since been created from the skin cells of patients suffering from amyotrophic lateral sclerosis (ALS) and Alzheimer disease and have been used as human models for the exploration of disease mechanisms and the screening of potential new drugs. In one such model, neurons derived from human iPS cells were shown to promote recovery of stroke-damaged brain tissue in mice and rats, and, in another, cardiomyocytes derived from human iPS cells successfully integrated into damaged heart tissue following their injection into rat hearts. These successes indicated that iPS cells could serve as a cell source for tissue regeneration or bioartificial tissue construction.

More here:
regenerative medicine | Definition, Stem Cells, & Facts ...