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DOJ Sues Two Companies Using Experimental Stem Cell Drugs
Drugs Postmarket Safety
The Department of Justice filed civil complaints in Florida and California to stop two companies offering unapproved stem cell treatments.
The complaints, filed against the California Stem Cell Treatment Center and the US Stem Cell Clinic, allege the companies manufacture stromal vascular fraction products that are marketed as stem cell-based treatments for a variety of serious conditions and diseases such as cancer, stroke and pulmonary disease.
The companies and their affiliates allegedly administered their products to thousands of patients without FDA approval and caused some adverse events.