The FDA is starting to get even more aggressive in enforcing their HCT/P regulations. The FDA statement yesterday makes it clear that what many of us have been saying for years is in fact true. #1 Stem cells, SVF, umbilical cord blood, amniotic fluid, Wharton’s Jelly, exosomes, and orthobiologics are all considered biologic drugs and ALL are improperly registered under section 361 for orthopedic applications.
*When is a level 2 scientific study NOT a level 2 scientific study?*
Answer: When it is a retrospective review of an insurance company database.
A recently published 2021 study by Dr. James Pritchett, is titled “The debit side of stem-cell joint injections: a prospective cohort study” and is listed as a Level 2 study by the journal…Current Orthopedic Practice.
just received our monthly report from Web MD and Healthgrades These websites are the two of the largest websites with verified reviews from real patients…..and we care that we are providing good orthopedic and regenerative medicine care. We have 391 5 star reviews on Web MD and 377 5 star reviews on Healthgrades.com Thanks sincerely to our patients for helping us fine tune our practice to serve them.
Chris Centeno, MD, founder of Regenexx and past President of the Interventional Orthobiologics Foundation, has collated and linked worldwide research on bone marrow stem cells. Each circle in the pic represents a hyperlink to the article! This amazing project shows the explosive research interest in bone marrow derived stem cells for many clinical uses.
I have been involved in recent discussions with patients and clinicians who were under the impression that there are stem cells in circulating blood and therefore also in platelet rich plasma. They have this impression from well known podcasts, from some doctor and chiropractic clinics, and in one case from a company still in the midst of a class action lawsuit whose business model was selling PRP as a stem cell treatment for severe pulmonary diseases (The Lung Institute).
Don Buford, MD will be presenting this research study next at the 2021 ARMI Spring Conference. In the study, patients with shoulder pain from rotator cuff tears were treating with cellular therapy (bone marrow concentrate) in a single in office injection. 2 years later, patients still had 80% pain reduction and were 84% better (SANE score) by their own report.
Well, at Texas Orthobiologics he is! There are educational responsibilities every year that are required to maintain Board Certification by The American Board Of Orthopedic Surgery.
A recently published article concluded that LR-PRP was better than LP-PRP or HA for knee arthritis in a cohort study with 3 treatment groups of 30 patients each. Interesting because many of us believe that LP-PRP is the better choice for intra-articular applications because of less inflammatory reaction and less potential activation of the catabolic cascade.
Based on Level 1 evidence in orthopedics, how much should a clinic charge for a PRP injection for knee osteoarthritis? We already know that PRP has been shown to work better and last longer than steroid or hyaluronic acid injections….that is a fact based on over 25 level 1 studies from around the world.
The FDA maintains a public website of their letters sent to companies in the orthobiologic field. Every company on this slide has received some form of FDA inquiry. Some of the offenses are more egregious than others with patients blinded or given tainted product resulting in septicemia and life threatening illnesses.
