By AURA BEIL
Published September 9,2013
The New York Times Health
The article is certainly worth a read as it underscores the world of stem cell clinics and the promises without scientific documentation for treatment of many maladies both in the US and around the world. The writer documented the sojourn of a retired Army nurse and her attempt at the cure of emphysema by traveling to Tijuana, Mexico for stem cell treatment. At the Regenerative Medicine Clinic in Tijuana, “adult stem cells are promoted as a cure for everything from sagging skin to severed spinal cords”. The author goes on to state, “On the surface, the claim is plausible.”
Let me explore for you what is fact and what is fiction and what the future might hold. While fat, bone marrow, skin, and other parts of the body contain stem cells, to date, these immature cells have been shown to rejuvenate themselves in the environment where they are naturally found. That’s why at Regenexx, we use bone marrow aspirate concentrate derived adult mesenchymal stem cells in the skeleton such as a joint, bone or ligament and tendon. In the United States, it is a violation of FDA rules to use stem cells derived from fat in unrelated organs, as was the case of the Army nurse who traveled to Mexico for fat derived stem cells to be placed in her lungs.
The real question though raised in the New York Times article is whether a patient seeking stem cell intervention for a hip, knee, etc., is enrolling in a trial or treatment? At Regenexx in Chicago, every procedure I perform is governed by an Institutional Review Board approved protocol and related bioethical considerations. With full HIPAA compliance, just as my historical practice when I did joint replacements while integrating patient care with research and education, every patient treated is enrolled in a very comprehensive clinical research protocol with IRB oversight. We are realistic about informed consent and the potential outcomes; hence our pretreatment algorhythm.
Is there a lack of data? The purpose of this Blog is to reaffirm my commitment to you. I presented my one year-stem cell outcomes data for the management of arthritis in Los Angeles, this past June. Regenexx is collating its outcomes data from the network as I write. Mary has worked non-stop with the PhD statisticians in Broomfield to finalize the next IRB Clinical Trial submission concerning a development in stem cell technology for arthritis following FDA guidelines. Our stem cell treatments are based on science.