About 15 years ago, an article was published regarding the use of Platelet Rich Plasma for the treatment of arthritis. Prior to that clinical trial, physicians would use hyaluronic acid (rooster comb) in an attempt to diminish the symptoms from an arthritic joint. The introduction of PRP heralded the beginning of orthopedic, clinical Regenerative Medicine. Our problem then was that no clear-cut definition of Platelet Rich Plasma was advanced; even today, there is a lack of standardization of the many available PRP offerings. That being said, I use the term Proprietary PRP to clarify my compounding of your platelets and plasma in controlling the pain generator in an arthritic joint; namely inflammation. Growth Factor Proteins (too numerous to describe here) contained in platelets and plasma, act as antagonists to the pain generators within the joint. When concentrated and injected into the painful, inflamed joint, symptoms disappear or are minimized and function improves.
Continuing with our webinar, it was the introduction of the Adult Mesenchymal Stem Cell into orthopedic practice 12-years ago, following FDA guidelines for clinical use, that allowed Regenerative Medicine to become a reality. At that time and continuing to the present, the possibility of cartilage regeneration in an arthritic joint can only be realized by a combination of stem cells, platelets and growth factors. The classic source of these joint regenerators is your bone marrow. In order to be FDA compliant, the harvested bone marrow must come from you and be concentrated, not expanded with addition other agents or through culturing.
FDA Approved Cell Based Therapy
Fast forward to 2019 when the first FDA approved Stem Cell Trial using adipose derived Stem Cells made available via Liposuction and processing was initiated by Personalized Stem cell, Inc. I was one of the several investigators involved and we are tabulating and analyzing data which will then hopefully allow us to move forward with the second phase of the Trial. While bone marrow gives us access to tens of thousands of stem cells, adipose tissue (abdominal fat) allows us to recover several millions of stem cells for processing and clinical usage. I will announce on my web site if and when the phase two trial is allowed by the FDA.
In the meantime, my practice based on various orthobiologic offerings to relieve symptoms of arthritis and improve functional capacity continues. While cartilage regeneration isn’t always an option owing to age or co-morbidities, such options including IRAP variations, Exosomes, and Proprietary PRP are available to maintain or restore an active lifestyle.
Finally, in part owing to lack of standardization and in part because of the charlatans and bad actors holding themselves out to be Regenerative Medicine “experts”-one can attend a 72-hour course and then upload a web site claiming expertise-The American Academy of Orthopedic Surgeons has initiated reform of the emerging discipline of regenerative medicine with consumer protection and physician continued education as the primary goal. I am a Board Certified Orthopedic Surgeon, Fellow of the American Academy of Orthopedic Surgeons and Fellow of the American College of Surgeons.
Good riddance to the quacks.
Tags: cell based therapy, cellular therapy, regenerative medicine