Four insights:
1. The U.S. alleges the defendants — Chief Scientific Officer Kristin Comella, PhD, for US Stem Cell Clinic and US Stem Cell — advertised “stromal vascular fraction” products as stem-cell based treatments for conditions such as spinal cord injuries, stroke and brain injury among others.
2. The defendants made the claims without FDA approval, according to the complaint.
3. A district judge ruled that the SVF products must adhere to the Food, Drug and Cosmetic Act.
4. The Court entered a permanent injunction banning the defendants from selling or providing the products without FDA approval.
“We are committed to continuing to pursue actions against those who put patients in harm’s way by marketing unapproved stem cell products that skirt FDA’s regulations and federal law,” said Acting FDA Commissioner Ned Sharpless, MD.
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