American CryoStem’s Atcell Not Approved for ALS, Other Neurodegenerative Diseases, FDA Warns
The U.S. Food and Drug Administration (FDA) has issued a warning to the American CryoStem Corporation of Monmouth Junction, New Jersey, for marketing Atcell, the company’s adipose-derived stem cell product, without FDA approval. In its warning letter, the FDA noted “significant deviations from current good manufacturing practice requirements, including some…