- Academic stem cell researchers are concerned about the unregulated use of experimental stem-cell procedures, some of which have resulted in patients' deaths, Reuters reports.
- Clinicians have been promoting the use of stem cells for various conditions, including treatment of Alzheimer's disease, arthritis, erectile dysfunction, hair loss, and neurological conditions. But stem cell therapy is not approved for treatment of these conditions.
- Although the FDA does not regulate stem cell therapy, late last year, the agency started to ramp up oversight with preliminary guidelines. The gist of the guidelines is that processing fat to extract stem cells for medical use creates a new drug, which cannot be sold without FDA approval.
There are roughly 170 stem cell clinics across the U.S. offering various stem cell-based procedures, and according to the clinicians running the clinics, there are some successes. However, there are some horrifying failures as well, according to the family members of victims.
Here's one worse-case scenario reported by Reuters: Richar Poling was having trouble breathing, and decided to have an $8,000 stem-cell procedure to improve his respiratory status. Fat was harvested from his abdomen and processed in an off-site facility in order to isolate the stem cells. It was later injected into his bloodstream, at which point he suffered cardiac arrest and died.
Unfortunately, this is not the only death resulting from unregulated use of stem cells. The FDA has become aware of this and it seems that a tipping point has been reached. New guidance is in the works.