Celltex Therapeutics Corporation, the Houston-based stem cell company where Texas governor Rick Perry received treatments for back pain last year, is moving to Mexico to sidestep pressure from the FDA to regulate its procedures.
CellTex is one of several companies that specialize in autologous stem cell injection therapy, where an individual's adult stem cells are isolated (usually from fat tissue), concentrated, and then reinjected to improve a medical condition. The thinking is that the stem cells can promote or speed up healing of injured or deteriorating tissue.
The scientific evidence supporting the efficacy of this stem cell therapy technique is scant, but more central to Celltex's recent business decision is that that the treatments are not FDA approved. Celltex was operating under the premise that, since the treatments involve reinjecting the patient's own minimally manipulated stem cells without additives, FDA oversight was not required. The FDA disagreed, however, and provided Celltex with a formal notice of its position in September 2012.
While Celltex responded to the FDA, it seems that, rather than battle the agency, it has decided to move the stem cell therapy portion of its business to Mexico. It will then be under the jurisdiction of Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS).
You can read Celltex's letter to its customers regarding the move on the Knoepfler Lab website, and find more information about Celltex's move and autologous stem cell therapy at the Genetic Literacy Project. Also, for more background on stem cells, see Delivering on Stem Cell Therapy Treatments, on this website.