FDA steps up enforcement, regulation of stem cell therapies

FDA said it is taking steps to rein in unscrupulous stem cell therapies while at the same time advancing regulatory measures to encourage development of safe and scientifically proven stem cell treatments.

In a statement Monday, FDA Commissioner Scott Gottlieb said cell therapies and their use in regenerative medicine hold promise as "transformative and potentially curative treatments" for many diseases including cancer, Parkinson's disease, and diabetes. However, Gottlieb said some "unscrupulous actors" have put "the entire field at risk" by making deceptive and corrupt claims based on unproven and potentially dangerous products. ...