Why an FDA legal victory won’t stop controversial stem cell clinics

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Image: Iris Schneider/Stat

When the Food and Drug Administration won a landmark lawsuit [June 3] against a stem cell company, health officials hailed it as a turning point in the governmentโ€™s struggle to regulate a booming industry selling unproven treatments to desperate patients.

But the reaction of the company โ€” Florida-based U.S. Stem Cell โ€” and the industryโ€™s ability to adapt to changing rules suggest the judgeโ€™s order may have less impact than many regulators and consumer advocates had hoped.

Initially, the company said it would follow a federal judgeโ€™s ruling and stop selling the fat-based procedure. But it quickly followed up with a clarification: It would continue offering stem cell treatments, but instead of fat, rely on patientsโ€™ bone marrow and other tissues to harvest the cells it claims can cure conditions as varied as spinal cord injuries and erectile dysfunction.

The FDAโ€™s lawsuit against U.S. Stem Cell is one of just a handful of stem cell clinics that it has sued because such battles require huge resources. The judgeโ€™s ruling โ€” after almost a year of extensive motions, reports and court filings โ€” affirmed FDAโ€™s authority to regulate the industry and deem such treatments illegal.

Read full, original post: Stem cell clinics likely to flourish despite judgeโ€™s rebuke

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