Cellular therapy is a relatively new concept. We are here to help you understand how our practice can benefit you.
The FDA guidance on the use of “STEM CELLS”
Southcoast Medical is part of the Bluetail Medical Group, a group that has been providing regenerative treatments since 2005, and is a leader in Orthopedic Regenerative Medicine. We are dedicated to the development and use of safe and effective regenerative therapies that we would use were we the patient.
Bluetail currently has an Investigational Device Exemption (IDE) (#27960) in place with the FDA.
In June 2021 the FDA began enforcement of its new regulatory pathway. This affects all healthcare providers, hospitals and businesses who provide these therapies and products. We encourage patients to research providers and clinics, and ensure they have and IND, IDE, or BLA in place with the FDA.
What is a Stem Cell?
Stem cells are precursor cells that are present as an organism develops, and later become specialized types of cells like heart or muscle. These cells have yet to differentiate and have retained the ability to become many types of cells. They are found throughout our bodies near vessels, in bone, in fat and even in organs like the brain.
Some cells like embryonic stem cells can become any type of cell, whereas Mesenchymal Stem Cells can only become any cell in the mesoderm line, such as bone, cartilage, ligament, tendon, muscle, etc.
How is Platelet Rich Plasma obtained?
PRP or Platelet Rich Plasma is a fraction of normal blood. To obtain this portion of plasma, a sample of blood is first obtained from the patient and mixed with an anticoagulant. That blood is then centrifuged and initially the red cells are discarded. A second centrifugation follows after which white cells and some plasma are discarded, leaving a PRP portion ready to be used.
Are Regenerative Procedures painful?
In general, there is very little discomfort involved during regenerative procedures and there is minimal discomfort after the procedure with almost no recovery time.
Does Medicare cover Biologic Therapy?
Currently, Neither Medicare nor any other major insurer covers the cost of biologic procedures. There have been a few carriers to cover PRP for specific applications.
Despite this, there remains great value in cell therapy procedures, considering there is no surgery or anesthesia risk, there is little pain involved and no recuperative period, and there are studies by leading researchers such as Phillipe Hernigou in France, showing better outcomes with biologic therapy when compared with joint replacement.
What are the most common Biologic Therapy applications?
The most common biologic applications in the treatment of musculoskeletal problems are:
- Knee arthritis
- Hip arthritis
- shoulder arthritis
- partial rotator cuff tear
- meniscus injury
- incomplete ACL tear
- spinal disorders
Cells and microsomes and PRP are used for a variety of other applications, such as bone marrow transplant in diseases like leukemia, and much research is being done to determine the feasibility of incredible possibilities like new organ growth. There is also an ongoing study right here in Charleston, SC to assess biologic therapy in the treatment of connective tissue diseases.
What is Regenerative Medicine?
Think of Regenerative Medicine as the opposite of degeneration.
We all know about degenerative disc disease and degenerative joint disease and see these things as a part of aging. Regenerative medicine uses many different approaches to stop degeneration, and instead grow new healthy tissue.
What type of training is required for a doctor to practice Regenerative Medicine?
Regenerative Medicine is a very new field. Researchers are busy trying to determine the potential of this exciting new field. How long will it be before we can grow new, healthy organs? This type of research is being done around the world every month.
We already know that regenerative medicine can do some incredible things, like treat arthritis, heal meniscus tears, and even heal partial Cruciate ligament tears. Much of this is through the use of stem cell. But believe it or not, many times the individual offering stem cell treatments is not even a doctor, but instead a chiropractor. These providers are not allowed by law to give injections, so they hire someone with a medical degree and bring them in their office to do injections. These injections are almost always allogenic cells (purchased cells from an embryo), done with no image guidance.
Additionally, there are sometimes physicians, with little experience treating muscle, joint and ligament disorders, who began offering stem cell to try to make a fast buck.
Clearly the best qualified stem cell provider would be an individual who is:
- a physician
- a provider with much experience with joint and spine injections
- experienced with the use of ultrasound and fluoroscopy
- experienced with PRP and stem cell through long term use
- associated with a network of physicians doing the same thing, in order to have the training, expertise, data, and knowledge base for all situations
At Southcoast Regenerative Medicine we meet all these criteria
Don’t wait……Schedule an appointment today
Is there evidence that Biologic Therapy works for arthritis pain?
There is a lot of evidence that the use of biologic therapy is effective in the treatment of arthritis.
Research from the University of Pittsburgh McGowan Institute for Regenerative Medicine under the direction of Rocky Tuan M.D. has confirmed that stem cells can grow new cartilage.
Clinical studies in North America and Europe have shown favorable outcomes with the use of cell therapy and bone marrow in the treatment of joint disease. My favorite is a study by Phillipe Hernigou, a stem cell researcher in France, comparing outcomes in cell therapy treatment of knee and hip arthritis, compared to surgery, in patients with avascular necrosis. In one of the studies patients with bilateral knee arthritis from osteonecrosis, agreed to have surgery on one leg and stem cell on the other and in the end 21/30 Patients favored the stem cell knee.
There is little question that the use of stem cell is the future of medicine.