Actually it is closer to stem cell misrepresentations and is being propagated by the uninformed clinician, clever marketing schemes, and out and out charlatans. Last week, the FDA made a very strong statement warning against the use of Adipose Derived Stem Cells in the treatment of arthritis. The Government Health Care oversight process stated that there would be large fines and perhaps imprisonment for those health care providers who do not comply with the law. The regulations clearly state that your stem cells may be used if not manipulated or expanded. In order to liberate stem cells from adipose tissue, the adipose tissue has to be treated with an enzyme collagenase, a clear violation of the law. Yet, there are the web sites too numerous to list marketing adipose derived stem cells for arthritis. I am aware of several clinics that circumvent the law by performing liposuction and injecting the fat into the joint without liberating the stem cells with collagenase. My response, beware and take care.
Then come those providers who use local anesthetics to expand the Bone Marrow Aspirate Concentrate when Regenexx has documented the death of stem cells if mixed with local anesthetics. Don’t stop reading, I have yet another alert. The latest addition to the field of Regenerative Medicine comes from Amniotic Fluid that is marketed as an allograft. The pregnant woman at term donates her amniotic fluid that is then processed and made available for wound healing or as an injectate for the arthritic joint in either a concentrated or powder form. While the early outcomes are promising for pain relief, no one has more than four months of outcomes monitoring for amniotic fluid preparations in arthritis. The processing laboratories claim an abundance of stem cells in the concentrate as well as large quantities of Cytokines and Growth Factors; but this is yet to be corroborated by independent researchers. The good news here is the latter research is taking place and more being planned; there should be preliminary data by mid 2015.
Assume if you will that you have an arthritic joint, and are not yet ready for a joint replacement or the extent of your arthritis still lends itself to non-operative management. How can you be sure that you are protected from the abuses I describe above? Regenexx initiated outcomes surveillance over five years ago and as an orthopedic surgeon, I joined and expanded those data points Regenexx studies two and a half years ago. No other Cellular Orthopedic or Regenerative Medicine initiative has the comprehensive Outcomes Data or basic research to support a clinical intervention recommendation, as do the members of the Regenexx Network. Beware here as well of non Regenexx Network web sites that post Regenexx Outcomes as if the patient is too uninformed to recognize the deception. If you want the truth, make an appointment: 847 390 7666
Tags: Amniotic, arthritis, athletes, Bone Marrow Concentrate, Clinical Studies, Interventional Orthopedics, joint replacement, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Regenerative, Regenexx, stem cells, treatment