News & Press Releases: Breaking News

US FDA Wins Landmark Court Decision Against For-Profit Stem Cell Clinic

Wednesday, June 5, 2019  
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Vancouver, BC, June 6, 2019 –  ISCT applauds the United States Federal Court landmark decision in a case brought by the FDA against a clinic offering unproven and unlicensed adipose-tissue-based cell products to patients with a variety of chronic and/or progressive diseases. This ruling affirms the authority of the FDA to regulate such products as drugs and to require rigorous demonstration of product safety and efficacy before commercialization.

ISCT considers this ruling an important step towards the regulation of an industry that has eluded regulatory oversight for many years, causing substantial financial, and in many cases, physical harm to patients through direct-to-consumer advertising of unproven and poorly tested “stem cell” treatments.

ISCT supports the FDA and other regulatory agencies in their increasing efforts to bring properly vetted cell and gene therapies to patients. In addition, the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell & Gene Therapy offers a variety of resources that can help medical professionals, patients and caregivers to make informed decisions regarding cell and gene therapy treatments.

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