12 people in hospitals after stem cell treatment

Infections put 12 people in hospitals after they received unapproved stem cell products

 

Twelve people in three states developed infections and were hospitalized after they got infusions or injections of stem cell products derived from umbilical cord blood that were contaminated with bacteria, according to a report published Thursday by the US Centers for Disease Control and Prevention. 

The patients in Arizona, Florida and Texas received stem cell products processed by Genetech Inc. and distributed by Liveyon LLC, the report says, adding that the products are not FDA-approved or lawfully marketed. 

The FDA sent a warning letter to San Diego-based Genetech in November about ReGen5, ReGen10 and ReGen30 for allogeneic use. The agency issued a statement about it Thursday and said it was sending letters to 20 other providers of stem cell treatments, reminding them of the agency's rules about regenerative medicine.

 

FYI ...

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