Judge grants FDA permission to regulate stem cell practice — 3 insights

Eric Oliver -   Print  |

A federal judge granted the FDA authority to regulate treatments from U.S. Stem Cell Clinic and U.S. Stem Inc., NBC News reports.

What you should know:

1. The FDA sought an injunction against the Florida-based clinics in May 2018 to prevent them from performing their treatments.

2. The FDA sought the injunction after three elderly women lost their vision after receiving stem cell treatments at U.S. Stem Cell. The FDA had already attempted to work with the Florida-based clinics to make them compliant.

3. The FDA has long decreed that stem cell treatments are not yet safe or effective.

FDA U.S. Center for Biologics Evaluation and Research director Peter Marks, MD, PhD, released a statement on the case. "In the case against U.S. Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. We are committed to pursue actions against those who put patients in harm's way by marketing unapproved stem cell products that skirt FDA's regulation and federal law."

More articles on regenerative medicine:
Zavation receives FDA approval for new spinal fusion device — 3 insights
Indiana device company receives FDA clearance for elbow system — 3 insights
Smith & Nephew acquires orthopedic joint reconstruction business — 4 insights

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies here.

Featured Webinars

Featured Whitepapers