A dozen people sickened after receiving unapproved stem cell injections
The FDA says at least 12 patients developed bacterial infections after receiving injections of stem cell products created with umbilical cord blood, including three patients who were hospitalized for more than a month. Last month, the FDA fired off a warning letter to Genetech, a San Diego company that processed the stem cells. Federal officials warned the company wasn't sticking to good manufacturing practices — and was marketing the products without FDA approval. “The company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” FDA Commissioner Scott Gottlieb said in a statement. The stem cells were recalled in October.