StemCell Therapy

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Regenerative medicine technologies are relatively new forms of treatment designed to enhance your bodys ability to heal itself. These treatments use natural substances that modify your natural healing mechanisms to help joints, tendons and ligaments heal and repair themselves.

There are three branches of regenerative medicine: Rejuvenation, Replacements, and Regeneration.

There are 3 types of regenerative medicine offered at our centers, including:

PRP is a mixture of growth factors and other proteins found in the platelets of your own blood. These platelets migrate to areas of injury in the body and initiate and enhance a healing response. PRP treatments utilize a technology where we draw your own blood, concentrate the platelets and growth factors, and inject them back into the body at sites of injury or degeneration. These proteins enhance the activity of the healing mechanisms and decrease the mediators of inflammation to help make a patient feel better and heal the injury.Download more information

Cell-based therapy is a mixture of growth factors, proteins and mesenchymal stem cells that are found naturally in the body. These substances can be harvested from either your fat or bone marrow and injected into areas of injury or degeneration to enhance healing and ongoing repair. These mesenchymal stem cells have the ability to differentiate into other types of cells and continue to help your healing over the long term. Download more information

Amniotic products use either fluid or tissue to protect, cushion and reduce inflammation in joints and tendons. Amniotic tissue contains bioactive proteins harvested from healthy voluntary donors and therefore allows this procedure to be minimally invasive. Download more information

I am a 52-year-old physician and CrossFit athlete. Dr. Arthur Valadie surgically repaired my left knee 12 years ago. The outcome was excellent. Recently, he injected stem cells in the same knee. My knee feels fantastic and there is no exercise I cant perform!

After two years of shoulder pain, Dr. Valadie offered the Lipogems stem cell therapy as an alternative to conventional rotator cuff surgery. I am now 90+ days removed from the procedure and honestly amazed with the result. Im 80% back to my pre-injury condition. I cannot recommend Dr. Valadie, his team and this procedure highly enough. Simply incredible. Thank you!

I have suffered with osteoarthritis for three years in my right knee. After having the stem cell replacement procedure in November 2017, I have less pain and inflammation in the knee. I have much more ease with daily activities and continue to see improvement. The procedure was simple and painless. There was some discomfort after, but only within the first 24 hours.

PRP treatments are most effective for chronic ligament and tendon sprains and strains, that have failed other forms of treatments. Some of the treatments that can benefit from PRP include:

In addition to the list above PRP can also be effective in osteoarthritis cases, by stimulating the healing process of the cartilage, which reduces the pain. The areas that can benefit from PRP include:

First, a small amount of blood is drawn from the patient. Preparation of the solutions can take 25-30 minutes. Once the blood is drawn, it is placed in a machine called a centrifuge, that spins the blood at a high speed. This machine helps separate the blood into red blood cells and concentrated platelets. Once the blood is separated from the platelets, the blood is discarded and what remains is a concentrated platelet-rich plasma, known as PRP.

A stem cell is a cell with the unique ability to develop into specialized cell types in the body. They may be used to help your body heal tissues that have been damaged due to injury or degeneration.

These cells can be harvested from adipose tissue (body fat) or bone marrow with a relatively minor procedure. This is done under local anesthetic to minimize the pain of harvesting. Discomfort from the harvest is usually relatively mild.

Mesenchymal stem cell injections help the body heal itself. The cells can turn into cell types appropriate for the body part which can then help aid in the healing process. These injections are significantly less invasive than surgery and can shorten recovery time and diminish the risks compared to traditional treatments.

There are four types of Cell-Based Therapy that use the latest biological drugs with anti-inflammation agents and steroids, used for inflammatory bowel disease (IBD). The goal for these four therapies is to cure IBD, cell-based therapies offer hope to patients when traditional treatments have failed.

This type of injection is a minimally-manipulated injectable allograft designed to reduce inflammation as well as to protect, cushion, and lubricate joints and tendons.

While a baby is in the womb, it is situated within the amniotic sac. Inside the sac, the baby is surrounded by amniotic fluid. Amniotic fluid is gathered by a relatively easy, minimally invasive procedure from a willing donor, that is neither harmful to the mother or baby.

These injections can counteract inflammation and the harmful proteins that can cause joint pain. This diminished inflammation as well as lubrication can decrease pain and improve function.

We are in the pioneering days of regenerative medicine. Compared to other traditional medical treatments, regenerative medicine treatments have fewer clinical studies because of the relatively recent development of these technologies. We use and follow all available clinical studies regarding these treatments, so we can provide evidence-based ethical regenerative medicine treatments. These treatments are provided by board-certified, fellowship-trained orthopedic surgeons and spine/pain management physicians.

No, insurance does not cover regenerative medicine treatments as it is a relatively new field of medicine. Fortunately, there are many pricing options depending on the treatment you choose.

These are non-surgical treatments. Depending on the mode of treatment, tissue can be obtained either from a healthy donor, a simple blood draw, or a slightly more invasive procedure to obtain mesenchymal stem cells depending on the treatment you choose.

While the complete healing process can take several months, the downtime after the procedure is extremely minimal compared to that of surgery recovery.

If you want to learn more about regenerative medicine, please dont hesitate to contact us. At Coastal Orthopedics, we offer same-day appointments at three locations across Bradenton, Florida to serve you better.

Contact Our Regenerative Medicine Concierge TodayCall Coastal Orthopedics at941-794-5868

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Regenerative Medicine Bradenton FL | Looking for Pain ...

Cord Blood & Regenerative Medicine

The therapeutic potential of cord blood continues to grow.

Regenerative medicine is the science of living cells being used to potentially regenerate or facilitate the repair of cells damaged by disease, genetics, injury or simply aging by stimulating the body's own repair mechanisms.

Why cord blood?

Think about it: the natural power and purity of your newborn's cord blood are responsible for healthy development during pregnancy. So it makes sense that they are the ones most likely to be called upon when studying ways in which science can help restore health.

Cord blood is being used in clinical trials for autism and cerebral palsy.

Over the last few years, cord blood applications have expanded beyond transplant medicine into areas of regenerative medicine in clinical research trials for autism and brain injuries.

After demonstrating that it's safe for children with Autism Spectrum Disorder (ASD) to receive cord blood, a clinical trial is now underway to determine the effects of using a child's own cord blood or unrelated donor cord blood in children with autism. ViaCord families are participating in this innovative research to help kids with conditions once thought untreatable.

Learn more about cord blood and autism

A clinical trial at Duke University recently showed that an infusion of a child's own cord blood appears to improve brain connectivity and motor function in children with cerebral palsy. Twenty ViaCord families participated in this exciting research. Results were published in Stem Cell Translational Medicine. A third study is now underway to determine the safety of using a sibling's cord blood.

Learn more about cord blood and cerebral palsy

Brain Injury:Stroke 68 andHypoxic-IschemicEncephalopathy (HI) 108

Cardiac: Hypoplastic Left Heart Syndrome (HLHS)119

Hearing:Acquired Hearing Loss118

Autoimmune Deficiencies:Type 1 Diabetes84

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Cord Blood and Regenerative Medicine | ViaCord

Regenerative Medicine at Seattle Sports & Regenerative Medicine includes the collection and use of therapeutic stem cells to regrow, repair, or replace damaged or diseased tissue within the musculoskeletal system, including: shoulders, elbows, wrists, hips, knees, and ankles.

As your physician, Dr. Wagner is committed to providing the highest level of care, priding himself on staying connected to the ever-changing medical community and the most advanced medical technology available. It is his promise, as your physician, to responsibly provide the most progressive treatments, as long as he is completely confident that they are safe and beneficial for his patients.

Stem cell therapy and Platelet Rich Plasma (PRP) injections are both offered to alleviate pain and repair injury in the bodys tendons and joints, proving to be very effective in such conditions as osteoarthritis, tendon injuries, meniscus and labrum tears. Over 5 million stem cell procedures for osteoarthritis have been performed in the United States with no significant adverse effects reported.

We understand that the use of stem cells may sound complex, however, stem cell therapy is just the opposite. It is a simple procedure, performed in our office during a visit lasting approximately 90 minutes. If you have questions or would like a consultation with Dr. Wagner to learn if you are a candidate for stem cell therapy, please contact Seattle Sports and Regenerative Medicine.

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Seattle Stem Cell Therapy Clinic - Regenerative Medicine

by admin on March 23, 2018 No comments

By: Matthew Fischer

The regenerative medicine arena consists of a wide range of innovative products. Congress, acknowledging the importance of this field, has established a new program via the 21st Century Cures Act to help spur development and provide for accelerated approval for regenerative medicine products similar to the FDAs fast track and breakthrough therapy designations. This new approval is the Regenerative Medicine Advanced Therapy (RMAT) Designation.

The RMAT Designation includes all the benefits of the FDAs other accelerated designations including early agency engagement and priority review; however, unlike the other designations, the RMAT Designation does not require evidence that the product offers substantial improvement over other therapies. For a drug to be eligible for the RMAT Designation, it must meet the following:

The Code of Federal Regulations sets forth specific guidelines for the designation request process. The office within the FDA tasked with reviewing these requests is the Office of Tissues and Advanced Therapies (OTAT).

In November 2017, the FDA issued draft guidance regarding this expedited program requesting comment from the industry. At the time, the FDA indicated that the agency had received 34 designation requests and acted on 31 of the requests. With this new regulatory framework and specific pathway, the FDA seeks to set the stage for the future with the goal of addressing unmet medical needs with reduced product development time.

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Non-Operative Solutions for Orthopaedic Pain

Regenerative Medicine refers to the processes by which specialized technology is used to create living, functional tissues to replace or repair tissue that has been lost due to damage, disease, or hereditary defects. For those struggling with limited mobility due to arthritis, injury, tendinopathy (disease of the tendons), or other forms of musculoskeletal inflammation, patients may be able to experience relief and avoid surgery by harnessing the healing potential of their own cells.

Adipose-Derived Cell TherapiesThis method utilizes fat cells, which have high concentrations of stem cells and other growth factors within them, to decrease inflammation and aid in healing. In a minimally invasive procedure, a doctor will retrieve a patients own fat cells and deposit them into a device that uses a saline agent to rid the cells of blood and oil. At that point, the fat tissue has been resized and holds the ideal material and performance properties to stimulate healing. The doctor will then inject the fat graft into the joint experiencing the arthritic pain to decrease inflammation and encourage healing.

Platelet Rich PlasmaCommonly referred to as PRP, platelet rich plasma utilizes a patients own blood to produce growth factors. Growth factors are naturally occurring proteins that bind to the cells in your body and stimulate growth, healing, and repopulation. With this minimally invasive procedure, a doctor will draw the patients blood and spin it in a centrifuge to separate the blood into layers. The layer, which is rich with growth factors and platelets, is extracted and reintroduced into the damaged joint to encourage healing and reduce inflammation.

Bone Marrow AspirateBone marrow the soft, spongy tissue found in the center of large bones is composed of both fluid and solid matter. It is rich in growth factors and regenerative stem cells. Unlike other cells in the body, these cells are able to replicate themselves into various types of tissue for healing. To utilize bone marrow to stimulate healing and regrowth in an arthritic joint, a doctor will extract bone marrow fluid (called aspirate) from a healthy bone in the body, generally the pelvis, and place it in a centrifuge to generate a concentration of powerful cells. These cells are then reintroduced into the arthritic joint to repair damaged tissue and decrease inflammation.

These procedures are some of the newest treatments available today. They offer patients a minimally invasive option to help relieve the pain of arthritis or injury and improve function. Our highly skilled medical doctors use state-of-the-art diagnostic tools, including musculoskeletal untrasound, high-definition on-site MRI, and X-ray, to obtain pinpoint accuracy during the procedures.

Make an appointment with one of our industry-leading physicians today to see if Regenerative Medicine is an option for you by calling (423) 697-8780.

The physicians at Center for Sports Medicine and Orthopaedics are highly regarded as leaders in their profession, not only in Chattanooga, but in the Southeast region. They continue to be at the forefront of offering patients the latest medical procedures and treatments toward ensuring the best possible outcomes. We are excited to offer our patients an innovative approach to treating pain and healing.

At Center for Sports Medicine & Orthopaedics, our highly trained and compassionate staff takes pride in providing personalized care to all of our patients. That starts with a full orthopaedic evaluation with one of our doctors to assess your needs and evaluate your treatment options. We have specialists who focus on specific areas of the body including the spine, shoulder, hand, elbow, hip, knee, foot and ankle.

Make an appointment with one of our industry-leading physicians today to see if Regenerative Medicine is an option for you by calling (423) 697-8780.

regenerativemed@sportmed.com2415 McCallie AvenueChattanooga, Tennessee 37404

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Regenerative Medicine - sportmed.com

What regenerative medicine options do you offer?

DMOS offers three types of regenerative medicine options, all commonly used to treat different musculoskeletal conditions, including arthritis, muscle strains, tendon and ligament injuries.

The injection type differs based on the patient assessment and their individualized needs.

By definition, PRP is a collection of growth factors (which are proteins that are important in the healing of injuries), that can have controlled levels of white and red blood cells, based on the healing process necessary. Laboratory studies have shown that the increased concentration of growth factors in PRP can potentially speed up the healing process. Many world-class athletes use PRP therapy to repair their sports injuries faster.

Technically, BMAC is a collection of growth factors and cells, which include stem cells. Physicians use BMAC when they believe the potential upside of containing mesenchymal stem cells (MSCs) is necessary for treatment.

This injection serves to help as a local anti-inflammatory and reset the bodys natural balance in the arthritic joint. In technical terms, APS is a denatured PRP that delivers proteins, which block arthritic pain receptors. APS may be the preferred course of treatment based on if the patient exhibits radiographic evidence of knee, hip or shoulder OA (osteoarthritis).

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Regenerative Medicine - DMOS - Des Moines Orthopedic Centers

Regenerative medicine promotes the reparative response of diseased, dysfunctional or injured tissue using stem cells. Researchers prepare the stem cells in a lab beforehand, and are manipulated to specialize into specific types of cells, such as heart muscle cells, blood cells or nerve cells. While Stem cell therapy requires no invasive surgery, these stem cells called placental-derived mesenchymal stem cells (MSCs) are prepared beforehand, and injected directly into the area of pain or injury of your joint, muscle, ligament, or tendon. This procedures objective is simply to relieve pain, while the new stem cells stimulate your body to repair itself and heal faster, by generating healthy tissue. Stem cell therapy has recently had a major breakthrough within the medical field, particularly in the field of Orthopedics, due to the potential of these stem cells ability to allow the body to heal itself, and possibly eliminate arthritis pain and other chronic or acute pain from injuries. Benefits of Regenerative Medicine:

What is it? Platelet-rich plasma (PRP) therapy is a revolutionary procedure that uses components of the bodys own blood cells to stimulate the natural healing process in certain orthopedic conditions.The bodys first response to any soft tissue injury (ligaments and tendons) is to deliver platelet cells. Filled with healing and growth factors, the platelets jump-start the repair process. The platelets are separated from the rest of the blood cells and put through a process called centrifugation, which increases the platelets concentration. These platelets are then injected into the area needed with different concentrations of other cells to enhance the bodies healing process and decrease pain. This quick procedure can also provide effective pain relief, eliminating the need for surgery and prolonged recovery.

If you are a candidate for regenerative medicine or PRP therapy, call Midwest Orthopaedics in Shawnee Mission or Overland Park, Kansas at(913) 362-8317orrequest an appointment online.

Amniotic tissue has been used for many years to treat a variety of medical issues and has had excellent results. More recently there has been application to orthopedic issues such as arthritis and tendon/ligament healing. The amniotic membrane is a layer of the amniotic sac, which is donated after birth and does not contain fetal tissue. It is dehydrated and stored and then rehydrated at the time of injection. The process is very simple and similar to a cortisone injection. The injection can decrease inflammation and promote healing through multiple growth factors. It is safe and very effective.

Many orthopedic conditions can be treated with PRP or Amnitoic Membrane injections, including chronic pain and stiffness associated with osteoarthritis. If you have pain, limited mobility, swelling, or sports injuries, chances are regenerative medicine therapy can benefit you, and has shown promising results, treating these common conditions:

If you are a candidate for regenerative medicine therapy, call Midwest Orthopaedics in Shawnee Mission or Overland Park, Kansas at(913) 362-8317orrequest an appointment online.

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Regenerative Medicine | PRP Therapy | Midwest Orthopaedics

Regenerative injection therapy for tendons, ligaments, muscles and spine conditions.

About Regenerative Injection Therapies (RIT).

Regenerative injections broadly deals with the use of biologic materials to enhance the body's own repair mechanisms to help heal previously non-reparable tissues. The goal of these non-surgical procedures is to help heal the source of pain, not to simply mask it. The exact mechanism is evolving, but science points toward enhancing and stimulating healing and stabilizing factors of the local tissues.

Regenerative injection treatments offer a viable alternative for individuals considering elective orthopedic surgery or joint replacement due to arthritis or injury. Patients experience very little down time and they typically avoid the long, painful rehabilitation periods that can follow surgery. Since 2014, Regenerative Spine & Musculoskeletal Medicine has provided state of the art regenerative cellular therapies to help patients find relief from pain without invasive surgeries.

The Procedures:

Prolotherapy:

This treatment involves injecting a proliferant (usually dextrose) into weakened or injured joints, ligaments, or tendons. With a precise injection of a mild irritant solution directly on the site of injury, prolotherapy creates a mild, controlled inflammation that stimulates the bodys natural healing mechanism to lay down new tissue on the weakened area. Additional treatments repeat the process, allowing a gradual build-up of tissue to help restore strength to the area and relieve pain. Injection sessions are done 3-6 weeks apart, and usually a series of 3 injection sessions is done and then the response is assessed. The average number of treatment sessions is between 3 and 6.

Perineural Injections:

Peri-neural injections involves injecting diluted dextrose solutions superficially along the pathway of chronically inflamed nerves. They can be used for any part of the body where nerve pain exists. After the first treatment, pain relief may initially last for a period of four hours to four days. Repeated treatments (usually 6-8 sessions) are necessary, given every 1-3 weeks.

Platelet Rich Plasma Therapy (PRP):

During PRP therapy, a small vial of your own blood is drawn and placed in a centrifuge to separate the platelet-rich plasma from other blood components. This highly concentrated platelet-rich layer contains growth factors and a variety of cells. Growth factors stimulate local cells for tissue repair and remodeling. Your PRP is injected into and around the area of injury. Several injections may be done at the injured site at one time to fully treat the area. Many times only one injection is needed. If there is an incomplete response to treatment additional injections may be advised.

Cell Therapy:

Stem cells(MSCs) are readily available and can be harvested from your bone marrow through a needle. Once injected into an area of injury, MSCs secrete bioactive molecules to modulate repair and offer the potential to regenerate injured cartilage, ligament, tendons, or muscle. MSCs can be thought of as the manager of your bodys innate healing potential. Many times only one injection is needed. If there is an incomplete response to treatment additional injections may be advised.

Lipoaspirate (Fat) Graft:

Lipo aspirate therapy is a gentle process that uses your body's own fat tissue to cushion and support areas of injury or damage as your body heals itself. The fat is taken from the stomach, flank or thigh areas using a local anesthetic. It is especially effective for areas where there are soft tissue defects such as tears or arthritis. This type of injection is used in collaboration with PRP or bone marrow aspirate cell injections, which deliver growth factors to the injured area.

Alpha 2 Macroglobulin (A2M):

A2M is a naturally occurring molecule found in your blood that acts as a powerful protector against cartilage breakdown and progression of arthritis. A small vial of your own blood is drawn and placed in a centrifuge to separate the blood components, then is injected. A2M attaches to and removes the destructive enzymes that damage cartilage cells in the joint. The A2M is soothing to the joint and acts like a natural anti-inflammatory.

What parts of the body can benefit from regenerative treatments?

Spinal Injections:

Spinal procedures can be performed with dextrose, platelet/growth factors, or cellular therapy for those who wish to avoid the effects of steroids. Epidural nerve blocks, spine ligaments, facet joint, sacroiliac joint and intervertebral disc injections with platelets/growth factors may be performed. The injection is performed in the same manner as conventional spine injections with the use of x-ray guidance to ensure accurate placement of the treatment.

Joint, tendon, ligament, muscle Injections:

Musculoskeletal injections can be performed with dextrose, platelet/growth factors, or cellular therapy for those who wish to avoid the effects of steroids. Whenever appropriate the injection is performed with the use of x-ray or ultrasound guidance along with full safety and sterile precautions.

What conditions can benefit from regenerative injections?

Will insurance cover my Regenerative Injection?

Insurance companies will not pay for the cost of the Regenerative treatment. The cost of your injection can be discussed after your visit once you and the provider have decided on the most appropriate treatment option for you.

What sets Regenerative Spine & Musculoskeletal Medicine apart from others?

As the popularity of RIT grows, other medical professionals are beginning to perform these procedures, with great variation in training and background. Rene S. Melfi, M.D. is a physician specializing in non-surgical spine, orthopedic and musculoskeletal performance and function. With three national board certifications and Fellowship training in interventional spine and musculoskeletal medicine, Dr. Melfi has been performing spine and orthopedic injections since 2002. Dr. Melfi is also certified in Integrative Medicine and Acupuncture, and offers suggestions to enhance your results with recommendations for proper nutrition and supplements.

Your procedure at Regenerative Spine & Musculoskeletal Medicine is carefully chosen based on review of the latest evidence based medicine. Image guidance with x-ray or ultrasound is used, when appropriate, to confirm accurate placement of cellular therapy to optimize your results.

Call today for your appointment and a premier experience in Regenerative Injection therapy in Central New York 315-701-4000.

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Syracuse Regenerative Medicine

Introduction

During the natural aging process of the human body, several organs and tissues undergo a large anabolic phase (during the first 3 decades of life) and they soon develop into a catabolic phase, which is slower and irreversible (from the 4th to the final decades of life).In the anabolic phase the skin is shiny, silky, has elasticity and a large turgor. There is a large volume of toned muscular mass.The catabolic phase starts in the fourth decade of life and acceleratesin many cases during the seventh decade . In this phase there is an absence of skin sheen and the appearance of wrinkles and senile spots (the dernal layer also starts to show signs of weakness, and this occurs because of the decrease of the proteins that make up the skins elastic system, such as collagen and glycosaminoglycan / GAG).Muscular mass loses its volume and tone progressively, causing the body to show visible signs of aging. Probably a high protein diet may be responsible for the final quality of our organs and tissues during the anabolic phase causing the body to be more resistant and durable. This high protein diet, when applied during the catabolic phase, can maintain a better skin quality and improved muscular mass.During the past 10 years, we have endeavored to understand the consequences of the different intrinsicand extrinsic processes that alter the harmony of the movements of the muscles of the lower third of the face.

The outline of the mouth is made from a complex muscular system, where the

muscle of the mouth actively links with the

muscles that tighten the angle of the mouth sideways,

acts in a secondary fashion in this muscular complex. One can easily see, by way of a systematic evaluation of these muscles, (movements such as :whistling, smiling, making a sad face, and pulling a face as if having a bitter taste in the mouth) .Each patient can present important asymmetrical and accented depressions, caused by the exaggerated contraction of some of these muscles.

Till today,these facial defects have been treated with facial implants (fillers) and some serious cases have been even treated using classical surgical procedures : Fillers as surgery didn t revolve the problems !

Our proposal is to demonstrate that, by way of a selective intramuscular injection, of an oily patented solution containing a mixture of Carbolic Acid with Peanut Oil Acid using endopeel technology created by inventors Dr.Alain Tenenbaum ( facial plastic surgeon) and Mauro Tiziani ( molecular biologist) , it is possible to decrease the force of one or more muscles, that are working harder and in disharmony with the other muscles in the complex muscular system around the mouth.

We believe that the mechanism that is developed, after the injection of the ,,Endopeel,, oily solution, is a selective pointed chemical reversible myolysis, limited within the injected area of the muscular mass. With preliminary tissue studies, we can see that this myolysis is totally reversible after 7 months.

We have acquired experience from more than 1000 clinical cases over the past 8 years. The majority of these patients were re-treated in the same muscles that were treated earlier. The average re-treatment period was 4-6 months, and usually, smaller doses of the patented oily solution were injected, due to the hyperfunction of the muscles movements being attenuated. The average dose per injection is about 0.05 ml and the distance between each point is approximatively 1.0 centimeter.

We found that this treatment is very efficacious as long as there is a clear and precise evaluation of the above mentioned muscle system.

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Endopeel Portal Main Website : Lifting,Tightening & Tissue ...

Regenerative medicine is a game-changer in the world of medicine. Treatments include: Stem Cell Therapy, PRP (Platelet Rich Plasma) Therapy and Amniotic Stem Cell Therapy (Amnion). Each custom treatment option may help to heal damaged tissues and organs, offering solutions and hope for people whose conditions have proven beyond repair previously.

I didnt know anything about PRP when I went to my appointment with Dr. Hall. I was able to do some research before I had anything done. The stem cells come from my own bone marrow. Stem cell treatment is fairly new, but shows positive results. I decided that it was something that could help me. I trust Dr. Hall. Dr. Hall removed the stem cells from my hip and injected them into my knees while I was in surgery under anesthesia.

I was in physical therapy after the surgery. Now Im back in the gym three days a week, exercising on the elliptical machine, weight training and in yoga classes. I walk five miles four or five days a week.

In six weeks, I was at 133 degrees range of motion, which was only 4 degrees behind my good leg. I attribute my advanced recovery to the outstanding hands of the DOC surgeon, the PRP/stem cell therapy, and Mike at ATI Physical Therapy.I attribute my advanced recovery to the outstanding hands of the DOC surgeon, the PRP/stem cell therapy, and Mike at ATI Physical Therapy.

If you are reading this testimonial and questioning whether the extra money spent on the PRP and stem cell therapy are worth it, I would highly recommend that you take out a loan if necessary in order to benefit from this healing therapy.

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Regenerative Medicine - directorthocare.com

Though great progress has been made in medicine, current evidence-based and palliative treatments are increasingly unable to keep pace with patients' needs, especially given our aging population. There are few effective ways to treat the root causes of many diseases, injuries and congenital conditions. In many cases, clinicians can only manage patients' symptoms using medications or devices.

Regenerative medicine is a game-changing area of medicine with the potential to fully heal damaged tissues and organs, offering solutions and hope for people who have conditions that today are beyond repair.

Regenerative medicine itself isn't new the first bone marrow and solid-organ transplants were done decades ago. But advances in developmental and cell biology, immunology, and other fields have unlocked new opportunities to refine existing regenerative therapies and develop novel ones.

The Center for Regenerative Medicine takes three interrelated approaches:

Rejuvenation. Rejuvenation means boosting the body's natural ability to heal itself. Though after a cut your skin heals within a few days, other organs don't repair themselves as readily.

But cells in the body once thought to be no longer able to divide (terminally differentiated) including the highly specialized cells constituting the heart, lungs and nerves have been shown to be able to remodel and possess some ability to self-heal. Teams within the center are studying how to enhance self-healing processes.

Replacement. Replacement involves using healthy cells, tissues or organs from a living or deceased donor to replace damaged ones. Organ transplants, such as heart and liver transplants, are good examples.

The center aims to expand opportunities for transplants by finding ways to overcome the ongoing donor shortage, the need for immunosuppression and challenges with organ rejection.

Regenerative medicine holds the promise of definitive, affordable health care solutions that heal the body from within.

Stem cells have the ability to develop through a process called differentiation into many different types of cells, such as skin cells, brain cells, lung cells and so on. Stem cells are a key component of regenerative medicine, as they open the door to new clinical applications.

Regenerative medicine teams are studying a variety of stem cells, including adult and embryonic stem cells. Also being studied are various types of progenitor cells, such as those found in umbilical cord blood, and bioengineered cells called induced pluripotent stem cells. Each type has unique qualities, with some being more versatile than others.

Many of the regenerative therapies under development in the Center for Regenerative Medicine begin with the particular patient's own cells. For example, a patient's own skin cells may be collected, reprogrammed in a laboratory to give them certain characteristics, and delivered back to the patient to treat his or her disease.

Stem cells and their use in regenerative medicine have been in the media a lot lately. But what exactly does it mean? Physicians and researchers in the Center for Regenerative Medicine say it has to do with developing completely new ways to treat and manage chronic diseases such as diabetes, heart failure, and degenerative nerve, bone and joint conditions.

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About Regenerative Medicine - Center for Regenerative ...

Regenerative medicine seeks to replace tissue or organs that have been damaged by disease, trauma, or congenital issues, vs. the current clinical strategy that focuses primarily on treating the symptoms. The tools used to realize these outcomes are tissue engineering, cellular therapies, and medical devices and artificial organs.

Combinations of these approaches can amplify our natural healing process in the places it is needed most, or take over the function of a permanently damaged organ. Regenerative medicine is a relatively new field that brings together experts in biology, chemistry, computer science, engineering, genetics, medicine, robotics, and other fields to find solutions to some of the most challenging medical problems faced by humankind.

When injured or invaded by disease, our bodies have the innate response to heal and defend. What if it was possible to harness the power of the body to heal and then accelerate it in a clinically relevant way? What if we could help the body heal better?

The promising field of Regenerative Medicine is working to restore structure and function of damaged tissues and organs. It is also working to create solutions for organs that become permanently damaged. The goal of this approach is to find a way to cure previously untreatable injuries and diseases.

1. Tissue Engineering and BiomaterialsTissue engineering is a strategy where biologically compatible scaffolds are implanted in the body at the site where new tissue is to be formed. If the scaffold is in the geometric shape of the tissue that needs to be generated, and the scaffold attracts cells the outcome is new tissue in the shape desired. If the newly forming tissue is subjected to exercise as it forms, the outcome can be new functional engineered issue.

Millions of patients have been treated with some form of tissue engineered devices, yet the field is in its infancy. The primary success stories have been with soft tissue regeneration. To learn more about some of the promising studies and clinical trials involving tissue engineering,click here.

2. Cellular TherapiesMany millions of adult stem cells are found in every human. Our body uses stem cells as one way of repairing itself. Studies have illustrated that if adult stem cells are harvested and then injected at the site of diseased or damaged tissue, reconstruction of the tissue is feasible under the right circumstances. These cells can be collected from blood, fat, bone marrow, dental pulp, skeletal muscle and other sources. Cord blood provides yet another source of adult stem cells. Scientists and clinicians are developing and refining their ability to prepare harvested stem cells to be injected into patients to repair diseased or damaged tissue.

To learn more about some of the promising studies and clinical trials involving cellular therapies,click here.

3. Medical Devices and Artificial OrgansIn cases where an organ fails, the predominant clinical strategy is to transplant a replacement organ from a donor. The principal challenges are the availability of donor organs, and the requirement that the donor take immunosuppression drugswhich have side effects. Further, there are many instances where the time to find a suitable donor organ requires an interim strategy to support or supplement the function of the failing organ until a transplantable organ is found. Using circulatory support as an example, there are technologies in various stages of maturity, initially using ventricular assist devices (VADs) as a bridge to a heart transplant, and now there are VADs that are used for long-term circulatory support (destination therapy).

Scientists and clinicians around the world are developing and evaluation devices to supplement or to replace the function of many organ systems including the heart, lung, liver and kidney.

To learn more about some of the promising studies and clinical trials involving medical devices and artificial organs, click here.

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An International Leader in Regenerative Medicine

The Wake Forest Institute for Regenerative Medicine (WFIRM) is a leader in translating scientific discovery into clinical therapies. Physicians and scientists at WFIRM were the first in the world to engineer laboratory-grown organs that were successfully implanted into humans. Today, this interdisciplinary team is working to engineer more than 30 different replacement tissues and organs and to develop healing cell therapies - all with the goal to cure, rather than merely treat, disease.

The Next Evolution of Medical Treatments

Regenerative medicine has been called the "next evolution of medical treatments," by the U.S. Department of Health and Human Services. With its potential to heal, this new field of science is expected to revolutionize health care. It is our mission at WFIRM to improve patients' lives by developing regenerative medicine therapies and support technologies.

"We have many challenges to meet, but are optimistic about the ability of the field to have a significant impact on human health. We believe regenerative medicine promises to be one of the most pervasive influences on public health in the modern era."-Anthony Atala, MD, Director

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Wake Forest Institute for Regenerative Medicine (WFIRM ...

STEM CELL TECHNOLOGY

Advanced Regenerative Medicine is using breakthrough technology in order to provide relief from osteoarthritisspecifically in the knee, hip, and shoulder joints. But what is regenerative medicine, and how is it being used to help patients avoid invasive joint replacement surgeries?

Regenerative medicine is changing the game in terms of how the body repairs and heals itself. This is especially beneficial to our senior population, who frequently experience pain from osteoarthritis in the hip, knees, and shoulders.

What is regenerative medicine? This medical treatment method is changing the way that medical professionals get to the root cause of injury, disease, osteoarthritis, and more. It is focused on rejuvenating the bodys ability to heal itself naturallywhich eliminates the need for surgery.

Regeneration delivers specific types of cells to diseased tissues or organs. The end goal is to help the tissue restore itself and return to its original functioning capabilities. This is achieved by using stem cell therapy.

Stem cells are a critical key to regenerative medicine. These cells are able to develop into another type of cell in the body, which helps tissues and organs rebuild and repair themselves. The idea behind regenerative medicine from ARM is to help a patients body heal on its own, while reducing risks and inconveniences associated with traditional joint replacement.

Regenerative medicine can help patients regain full range of motion of hip, knee, and shoulder joints. Furthermore, they will experience substantially reduced levels of pain. This approach is minimally invasive and can be conducted on an outpatient basis.

ARM uses cutting-edge technology to extract adipose-derived stem cells from adipose tissue. This enables ARM to eliminate the use of foreign enzymes and chemicals, which makes the process safer.

If youre unsure if regenerative medicine and stem cell therapy is right for you, our helpful staff can help guide you through the process and make the best decision for your needs. To learn more about stem cell procedures and regenerative medicine, contact Advanced Regenerative Medicine today.

Dr. Mark R. LoDico, a pioneer in the field of pain medicine, believes that no one should have to live with the frustration of chronic pain. Board Certified in both Anesthesiology and Pain Medicine, he founded Advanced Pain Medicine in 2001, uniquely committing the practice to finding specific, ongoing solutions to specific pain.

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What is Stem Cell Regenerative Medicine? | Advanced ...

ORTHOPAEDIC MEDICINE SPECIALTIES FOR PAIN TREATMENTOrthopaedic medicine is a specialty devoted to the evaluation, diagnosis and non-operative treatment for pain caused by musculoskeletal diseases to aid in pain management. Diagnostic modalities include a comprehensive history, a detailed and specific physical examination, radiologic evaluations and local anesthetic blocks for pain treatment. Therapeutic modalities for pain management encompass manipulations, corticosteroid or proliferant injections with and without fluoroscopic guidance, therapeutic exercise and use of pharmaceutical, nutriceutical, herbal and/or homeopathic based pain treatment.

The evolution began in 1741 when Nicholas Andre, at that time a Professor of Medicine at the University of Paris, coined the word orthopaedic. He published a book with the same title. The etymology of orthopaedic is based on two greek roots: orthos and paedia which translate to straight and rearing of children respectively. His illustration of a staff that is used to straighten a growing tree is known world wide.

For more than two centuries orthopaedists were physicians or surgeons concerned with musculoskeletal deformities: scoliosis, infections of bones and joints, poliomyelitis and congenital defects such as Erbs palsy, clubfoot and hip dislocations. Until the 20th century most orthopaedic treatments were manipulations and mechanical support with braces and plaster casts.

The American Orthopaedic Association was founded in 1887. The separation of orthopaedic surgery from general surgery took place in 1934 with the establishment of a separate board. According to the late Dr. Cyriax, orthopaedic medicine was established in 1929. The American Association of Orthopaedic Medicine was founded in 1982.

The accumulation of knowledge remains constant. The evolution of pain management continues.

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Home - Vermont Regenerative Medicine

CTI was named the winner of the Vision Award category, which was awarded to the organization for inspiringand deliveringnew thinking to the marketplace and for showcasingNorthern Kentucky as an area of thoughtful, innovative industry leaders.

"We're honored to be recognized by the Northern Kentucky Chamber of Commerce with this award for CTI's continued successes and innovations," according to Timothy J. Schroeder, Founder and CEO.

CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization announces the acquisition of Eurotrials, a full-service contract research organization, with more than 20 years of experience, and strong local expertise in Europe and Latin America.

CTI is extremely happy to partner with Bexion on the development of this novel therapy in patients who desperately need alternative treatments, stated William Aronstein, PhD, MD, FACP, Vice President, Medical Affairs at CTI. They are an innovative organization with very strong regional ties the drug was initially developed and licensed at a local hospital, early funding has predominantly come from the region, and the management and board have strong local connections.

The expansions in Taiwan and Japan are part of continued efforts to increase capacity for clinical research across Asia, according to Patrick Earley, Vice President, International. We have been working across Asia for a number of years, but felt like a more permanent presence in Taipei and Tokyo would further enhance relationships with local medical centers and biotechnology companies."

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CTI - CRO Specializing in Clinical Research and Consulting

Resource page

For the purposes of the information provided on this page we have adopted the definition of the term regenerative medicine that was used in the House of Lords Regenerative Medicine Report (see below). This was:

regenerative medicine is used to refer to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices.

Each regulator has a clear remit and regulates distinct areas of the regenerative medicine process. However, we work closely together to provide effective advice and guidance to support establishments through the regulatory requirements. Each regulator has a core set of standards that apply depending on where you are in the process, from cell derivation to treatment. We are all focused on ensuring that the standards that are applied at one stage of the process do not act as a barrier at another.

The role of each of the regulators in regenerative medicine is set out below:

Health Research Authority (HRA) has a remit to provide an ethics opinion on clinical trials. Those involving gene therapy regenerative medicines are reviewed through the Gene Therapy Advisory Committee (GTAC). Other regenerative medicine studies may be reviewed by other appropriately flagged RECs. It also provides the Integrated Research Application System (IRAS) through which applications and approvals from GTAC/RECs and MHRA for clinical trials involving regenerative medicines can be made.

Human Fertilisation and Embryology Authority (HFEA)[external link] regulates the use of human embryos or human admixed (human-animal) embryos to derive stem cells for use in the treatment of patients.

Human Tissue Authority (HTA) [external link] remit includes regulation of organisations that remove, store and use of human tissue or cells; this includes where they are used as starting materials for Advanced Therapy Medicinal Products (ATMPs). Under the European Union Tissues and Cells Directives (EUTCD), it licenses establishments that remove, test, process, store, and distribute tissues or cells that will (or may) be used to treat patients.

Medicines and Healthcare products Regulatory Agency (MHRA)[external link] remit includes responsibility for granting the appropriate authorisation for the manufacturing site of ATMPs, which are prepared and used under the hospital exemption, and for ATMPs made and supplied under the specials scheme under the relevant provisions in medicines legislation. In the area of clinical trials, the MHRAs remit includes assessment of applications for clinical trial authorisation and the associated manufacturers licence for investigational ATMPs. The National Institute for Biological Standards and Control (NIBSC) [external link], which houses the UK National Stem Cell bank, is part of the MHRA.

Please refer to the Research Community area of the website for information about the approvals for research studies and how to apply to individual review bodies. Further information about GTAC is also provided on this site. Additionally the Stem Cell Toolkit [external link] provides regulatory routemaps that are specific to individual stem cell projects.

Department for the Environment Food and Rural Affairs (DEFRA) [external link] has an Advisory Committee on Releases to the Environment (ACRE) [external link], which advises government on requests for permission to release genetically modified organisms (GMO) into the environment. In 2013, this committee published advice on gene therapy clinical trial for heart disease.

Health and Safety Executive (HSE) [external link] has the Scientific Advisory Committee on Genetically Modified Organisms (Contained Use) SACGM (CU) [external link]. This committee provides technical and scientific advice to the UK Competent Authorities on all aspects of the human and environmental risks, and is responsible for maintaining guidance on the contained use of GMOs.

From 13 October 2014, the MHRAs Innovation Office is the portal for all regulatory queries concerning regenerative medicines. A one stop shop service provides a single point of access from the four regulators in the field, the Human Tissue Authority (HTA), the Human Fertilisation and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA), who will provide a co-ordinated single response service for free regulatory advice.

Any query relating to the regulation of regenerative medicines, including Advanced Therapeutic Medicinal Products (ATMPs) can be submitted to the MHRAs Innovation Office and will be answered by the relevant experts from the four regulatory bodies.

Individuals or companies who have regulatory questions concerning regenerative medicines and who are unsure which agency to direct their inquiry to, or have a query that impacts several regulators, should use the Innovation Office advice form.

The HRA and others work closely together and will continue to engage with those involved in regenerative medicine, including researchers, the British Society for Gene and Stem Cell Therapy [external link], and the Cell Therapy Catapult [external link] to help clarify the regulatory requirements that apply.

The HRA recently held a regenerative medicine event hosted by the Cell Therapy Catapult to look at changes and discuss issues with the sector, regulators and representative bodies. Additionally in 2012, the MHRA hosted an event on the regulation of regenerative medicine [external link].

As set out in the Government Response to the House of Lords Inquiry [external link] a Regenerative Medicine Expert Group (RMEG) is being established to develop an NHS regenerative medicine delivery readiness strategy and action plan. This group will build on existing initiatives so that the NHS is fully prepared to deliver these innovative treatments. The group will be supported by the Department of Health; members will be drawn from a number of groups and organisations, including the HRA. The remit of the Regenerative Medicine Expert Group will include a role to monitor the effect of regulation on the development of regenerative medicines in the UK.

More generally, the HRA is working in partnership with a range of organisations to improve the environment for research in the UK. Please refer to our projects and plans pages for more information.

During 2012-13, the House of Lords Science and Technology Committee held an inquiry into regenerative medicine in the UK. For more information about the inquiry, the resulting report and the HRAs responses please use the links below:

UK Stem Cell Toolkit [external link]This toolkit is intended to be a reference tool for those who wish to develop a programme of human stem cell research and manufacture, including clinical applications. It applies only to the regulation of human stem cells and their use in the laboratory and clinical settings. The toolkit provides regulatory routemaps that are specific to individual stem cell projects. It does this by using your responses to questions when you start using the toolkit.

Clinical Trials Toolkit [external link]This toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. It provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials. The toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) and the regulatory environment and requirements associated with these. However researchers and R&D staff working on trials in other areas will also find useful information and guidance of relevance to the wider trials environment.

Cell Therapy Catapult [external link]The Cell Therapy Catapult was established in 2012 to grow the UK cell therapy industry. It was set up to help businesses take innovative ideas through to commercialisation. The website has specific regulatory resource pages, which include an overview of the relevant regulations for cell therapy.

MHRA Innovation Office [external link]The MHRA Innovation Office helps organisations that are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies. Examples of innovative products include Advanced Therapy Medicinal Products (ATMPs), nanotechnology, stratified medicines, novel drug/device combinations, and advanced manufacturing.

UK Regenerative Medicine Platform (UKRMP) [external link]The Medical Research Council (MRC), Biotechnology and Biological Sciences Research Council (BBSRC) and the Engineering and Physical Science Research Council (EPSRC) have established the UKRMP to address the challenges associated with translating scientific discoveries towards clinical impact.

UK Stem Cell Bank [external link]The UK Stem Cell Bank was established to provide a repository of human embryonic, foetal and adult stem cell lines as part of the UK governance for the use of human embryos for research. Its role is to provide quality controlled stocks of these cells that researchers worldwide can rely on to facilitate high quality and standardised research. It also prepares stocks of EUTCD-Grade cell lines for use as starting materials for the development of cellular therapies. The UK Stem Cell Bank is hosted by NIBSC [external link], which is part of the MHRA.

UK Trade & Investment (UKTI) Life Science Investment Organisation (LSIO) [external link]This dedicated unit within UKTI is intended to support overseas companies to invest and expand in the UK from the earliest research and development collaborations through to clinical trials, commercial operations and partnerships.

Knowledge Transfer Network (KTN) Regenerative Medicine Priority Area [external link]This is an official group within the Healthtechnologies and Medicine Knowledge Transfer Network (KTN). Knowledge Transfer Networks have been set up by the Technology Strategy Board (TSB) to facilitate collaboration and stimulate innovation by bringing together people from a range of organisations with a variety of expertise.

DEFRA Advisory Committee on Releases to the Environment (ACRE) [external link]

HSE Scientific Advisory Committee on Genetically Modified Organisms (Contained Use) (SACGM (CU) [external link].

MHRAs Clinical Trials, Biologicals and Vaccines Expert Advisory Group[external link]

Regenerative Medicine Expert Group [external link]

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Regenerative Medicine - Health Research Authority

Apex Sports and Regenerative Medicine, established by Dr. Daniel Savarino, recently opened its doors in Tinton Falls to meet the growing need for Sports Medicine services in Monmouth County. Dr. Savarino is here to answer your most pressing questions about Sports Medicine, musculoskeletal injury and the services offered at Apex Sports and Regenerative Medicine.

What kind of injuries do you treat?

Musculoskeletal injuries can happen to anyone, regardless of age, fitness level or whether or not you are an athlete. Sports medicine physicians treat injuries that affect mobility, flexibility and strength and help prevent movement-related injuries.

Musculoskeletal injuries can be acute or chronic. Acute injuriesoccur because of an impact, fall or trauma and might include a sprain, strain, dislocation or fracture. Acute injuries should be treated immediately. Chronic injuries develop over time, as a result of repetitive motion, or when you dramatically increase the duration, frequency or intensity of an activity. Chronic injuries can also occur when you do not warm up sufficiently before beginning an activity, or use improper technique and/or equipment. Chronic injuries include stress fractures, tendinopathy or shin splints. If left untreated, chronic injury will become more severe over time.

What exactly is a sports medicine specialist?

A sports medicine specialist is a physician who has received training in the prevention and non-surgical management of injuries, or an orthopedic surgeon with specialized sports medicine training. At Apex Sports and Regenerative Medicine we specialize in non-operative and regenerative treatments.

Over 90 percent of injuries treated by a sports medicine specialist are non-surgical, according to the American Medical Society for Sports Medicine. At Apex we offer cutting edge, minimally invasive procedures using ultrasound guidance, which result in less downtime than surgery, so youre able to resume your favorite activities more quickly. We also offer a wide range of regenerative treatments, like PRP, stem cell therapy and high dose laser therapy to help your body recover from injury.

What happens at a typical appointment?

To diagnose your injury and determine treatment, we will take a thorough history of your health background and activities, as well as a physical exam. We may also take X-rays or conduct imaging tests, depending on the nature and severity of the injury.

You dont have to be a competitive athlete to benefit from the care of a sports medicine doctor. Whether youre suffering from a musculoskeletal injury, hoping to alleviate pain and increase mobility so you can carry out daily activities, or youre an athlete hoping to improve your performance, a sports medicine physician can design and carry out a treatment plan to help you to stay active.

Do you accept my insurance?

Insurance carriers refer to Apex as an out-of-network facility. This does not mean that we do not accept your insurance, but rather, it means that we do not currently have a contract with your health insurance provider. However, if you have an insurance policy with out-of-network benefits (i.e., a PPO policy), you can be reimbursed for your visit. Our staff is happy to answer any questions about insurance and payment.

Apex Sports and Regenerative Medicine is located at 55 N. Gilbert St. suite 1101 in Tinton Falls and is open Monday-Friday. To learn more about the practice or to schedule an appointment with Dr. Savarino, please call the office at 732-385-APEX (2739) or visit our website at apexsportsnj.com.

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Meet Dr. Daniel Savarino - centraljersey.com

Tuesday, September 5, 2017

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued alengthy statement on August 28, 2017on the FDAs new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.The short version is that the Agency will:

Step up enforcement against stem cell actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk. To that end, Dr. Gottlieb also announced the creation of an internal working group to identify and pursue such actors and clinics through whatever legally enforceable means are necessary to protect the public health.

Develop and advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field, based on FDAs existing authority. The science-based policy would be aimed at accelerating the proper development of stem cell and other regenerative medicine products, and it is expected to be released Fall 2017. Dr. Gottlieb also noted that the Agency would be issuing a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization. And we will also be developing a novel approach to FDA approval that we believe will allow very small product developers to gain all the benefits of FDA approval through a process that is minimally burdensome and less costly. The latter part of this statement clearly takes into account that individual clinicians working in academic hospitals and other venues to innovate in their respective specialties make up a large portion of regenerative medicine product developers, and putting in place an overly burdensome or expensive process would not be in the publics best interest.

The widely differing viewpoints about the appropriateness of FDA oversight of human cell and tissue-based products (HCT/Ps) and their potential risks and benefits were aired during a two-day public hearing in September 2016, as wereported on at the time. From the second prong of Dr. Gottliebs announcement, we would expect that the four draft HCT/P guidance documents debated during the public hearing may be revised or finalized, and they may also be supplemented with additional guidance to further clarify jurisdictional lines or procedural flexibility for very small product developers.

In conjunction with the Commissioners statement, FDA also took specific enforcement action against two high-profile stem cell entities operating in California and Florida:

Supplies of smallpox vaccine, intended to be mixed with fat-derived stem cells and administered to patients as a treatment for cancer, were seized from San Diego-based company StemImmune Inc. Related to the Governments investigation into the unapproved stem cell treatment will be how the company obtained access to the smallpox vaccine in the first place, as it is not commercially available. FDAs announcement about the StemImmune action is availablehere.

A Warning Letter was issued to US Stem Cell Clinic in Florida related to its manufacture of an unapproved drug using fat-derived stem cells and deviations from good manufacturing practices for cell-based products. The Agency announcement about the US Stem Cell Clinic action, along with a link to the complete Warning letter, is availablehere.

US Stem Cell Clinic quicklysubmitted a response to FDA, which it has alsoposted on its website, and which challenges the legal basis for Agency action against a patients own body tissue. We will continue to monitor this case to see whether it progresses into a Federal judicial review of FDAs approach to regulating HCT/Ps.

Finally, as we previously reported, the December 2016 bipartisan 21st Century Cures Act (Cures Act) included a newaccelerated approval pathway for regenerative medicineproducts. FDA has begun implementing the Cures Act provisions under itsRegenerative Medicine Advanced Therapy (RMAT) Designation program. Commissioner Gottliebs recent statement also emphasized the relationship between realizing the promise of the Cures Acts RMAT Designation Program and the need to effectively police the growing marketplace of unproven stem cell treatments. His strongly worded August 28th statement ended with the following:

We must put in place the framework to separate the promising treatments from those products that pose significant risks or offer patients little to no chance of benefit. We will also continue to take steps to keep those who would exploit this promising area from harming patients and abusing the publics trust. We cant let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science.

We are hopeful that the Agency will follow these words with consistent enforcement actions (especially given how manyhundreds of self-named stem cell clinicscurrently operate in the U.S.), in order to enhance regulatory certainty and encourage investment in legitimate business enterprises. The House Energy and Commerce Committee has already confirmed that it will soon be examining the potential effect of unproven stem cell therapies on the broader regenerative medicine field, as part of its oversight of Cures Act implementation more generally. Of course, we will keep our readers posted on important developments regarding these issues.

1994-2017 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

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FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine ... - The National Law Review

Posted Aug. 30, 2017

The AVMA House of Delegates passed a new policy July 21 on "Therapeutic Use of Stem Cells and Regenerative Medicine."

According to the policy: "Regenerative medicine is defined as the use of biological therapies including platelet rich-plasma, pluripotent stem cells, and multipotent stem cells to effect therapeutic benefit in disease states. While regenerative medicine holds promise of improvements in the treatment of a variety of diseases, many of which lack adequately effective treatments, questions remain. The AVMA supports the continued scientific development of these modalities while at the same time encouraging its members to employ caution with respect to their use.

"While data continue to accumulate suggesting therapeutic benefit from regenerative medicine, published peer-reviewed studies definitively documenting benefit are still lacking for many diseases. Nor has a scientific consensus for stem cell type, stem cell origin, dosage, transfer media, or method of administration been developed for each disease being treated. Despite these scientific insufficiencies, the adoption of regenerative medicine in the veterinary profession has grown rapidly. Unfortunately, some therapies being propounded and the processes and equipment being sold have outpaced the science which supports them. Veterinarians have few guidelines and limited resources for differentiating valid and effective therapies from ones which have insufficient data supporting the processes and/or therapies. Therefore, it is incumbent upon veterinarians engaged in regenerative therapies to be well versed in the emerging science of the field in order to successfully select the specific therapeutic protocols, processes, equipment, and vendors most likely to result in clinical benefit for their patients."

The policy lists nine considerations for use of regenerative medicine by veterinarians.

AVMA to deliberate on assistance animals, stem cells (June 1, 2017)

FDA finalizes guidance on cell-based products in animals (July 15, 2015)

Stem cells in theory & practice (Feb. 15, 2011)

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Policy addresses therapeutic use of stem cells, regenerative medicine - American Veterinary Medical Association