Apparently it’s like the Wild West in the stem-cell business and the FDA has decided it’s time to tame it. The agency announced yesterday that it is stepping up efforts to oversee the fledging regenerative medicine industry, the Wall Street Journal reports.
The agency is developing rules to control the development of treatments using stem cells. It is also is cracking down on companies that are selling stem-cell treatments that can be harmful.
FDA Commissioner Scott Gottlieb said in a statement: “Our actions … should also be a warning to others who may be doing similar harm. We will take action to ensure Americans are not put at unnecessary risk.”
Stem-cell therapy is still largely in the experimental phase. That hasn’t prevented about 570 stem-cell clinics opening that promise to help people with everything from arthritis to Lou Gehrig’s disease to any number of other ailments. The cells are taken from one part of a patient’s body and injected into the ailing area after purportedly being processed.
“Clinic operators argue that the agency’s oversight of drugs doesn’t extend to the use of a patient’s own cells,” the WSJ reports. “Critics of the clinics express concern about potential harm to unsuspecting customers. There have been scattered reports of injuries, including deaths and permanent eye damage.”
Source: Wall Street Journal