Here are five things to know:
1. Many facilities have avoided regulations because the cells are extracted from a patient’s own body and the physicians did not alter the cells very much prior to reinjecting the cells.
2. In December, the FDA sent a warning letter to a network of stem cell clinics in California, New York and Florida. The FDA advised the network’s owner to obtain FDA licenses and approval to sell and use stem cells.
3. A public hearing has been set for April, and many patients plan to attend the hearing to fight for their right to use their own cells.
4. The FDA’s decision follows pleas of various medical professionals who seek a crackdown on stem cell therapy, which they claim is an unproven, and sometimes dangerous, therapy.
5. In 2012, the FDA issued a public warning regarding stem cells and has sent warning letters to clinics in recent years. Many clinics the FDA targeted have moved their facilities outside of the United States.
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