Regulations and Controversy

One common therapeutic use of stem cells by US physicians is to harvest them from one part of the body and then re-implant them at the site of an injury—where they are most needed but are in short supply. This can be an effective way to stimulate healing at sites of injury. But the one problem is that the quantity of stem cells is only as good as the patient's supply. To counteract this, an effective strategy is to grow the patient’s stem cells in a culture media.

However, the above approach is creating the danger of these new therapies becoming regulated by the FDA. The FDA is trying to establish its jurisdiction by saying that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug. However, physicians and organizations are pushing back by arguing that stem cell therapy is the practice of medicine and the FDA isn’t chartered to do that. They liken it to infertility clinics where physicians must grow a woman’s fertilized oocytes. So organizations such as The American Stem Cell Therapy Association (ASCTA) are being formed to establish guidelines and standards.

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