Stem Cell Firm May Have Administered Unproven Treatments 221
ananyo writes "With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company. Celltex Therapeutics 'multiplies and banks' stem cells derived from people's abdominal fat and its facility in Sugar Land opened in December 2011 and houses the largest stem-cell bank in the United States. But Nature has uncovered evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases."
The loop hole here... (Score:5, Informative)
The company is injecting patients with their own stem cells after massive multiplication of “minimally modified” stem cells.
This seems to be something of a loop hole in current regulation.
Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.
...
The legal standing of stem-cell treatments is currently being debated in a court case brought by Regenerative Sciences of Broomfield, Colorado, which was ordered by the FDA in 2010 to stop administering mesenchymal stem cells to patients5. One of the key issues being debated is whether the cells are “minimally manipulated” before being reinjected into the patient. Treatment with the patient's own, unprocessed tissue does not always require FDA approval.
I'm betting this gets reigned in somewhat, if not by the FDA, then by Texas, as the state has already made it clear it wants some oversight.
This whole thing sounds like several bad made for TV movies I've seen.