FDA: “The Food and Drug Administration is stepping up oversight of fledgling medical treatments that aim to harness the potential of stem cells—as well as some businesses that the agency said were selling unapproved and possibly harmful treatments.
The FDA announced it was crafting rules to govern the development of treatments based on the cells. The FDA also said it was cracking down on a company and three clinics that sold stem-cell treatments the agency said were potentially dangerous.
The moves signaled the FDA planned to extend its authority regulating drugs and medical devices to the field known as regenerative medicine, after spending years effectively watching it emerge…
Stem cells develop into many different kinds of cells and naturally replace skin, gut and bone-marrow tissues. Scientists at universities and biotech companies are studying whether stem cells could be used to treat diseases and grow replacement organs.
Though that research is still largely experimental, clinics have popped up, injecting stem cells into people dealing with Lou Gehrig’s disease, arthritic knees and other ailments. Often the stem cells are extracted from one part of the patient’s body, such as fat or bone marrow, and after purported processing, injected into a different, ailing area.”
-Jonathan D. Rockoff, “FDA to Expand Its Authority Over Stem-Cell Treatment Facilities,” The Wal Street Journal online, Aug. 28, 2017 06:11pm