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ISCT Files Amicus Brief Supporting FDA's Authority to Regulate Unproven Stem Cell-Based Interventions

  

The International Society for Cell & Gene Therapy (ISCT) has filed an amicus curiae brief to support the U.S. government's appeal in U.S.A. v. California Stem Cell Treatment Center, Inc., a case that ruled against the Food and Drug Administration (FDA) regulation of stromal vascular fraction (SVF) products and SVF expanded products thus jeopardizing the safety of patients.

The brief was filed in the U.S. Court of Appeals for the Ninth Circuit to provide the court with accurate, up-to-date scientific information which supports the need for the FDA to be permitted to use its scientific and medical expertise to evaluate the efficacy of and manage the risk of products intended for consumers and to take appropriate enforcement actions to protect the public from danger. 

ISCT believes that the U.S. v. California Stem Cell Treatment Center, Inc. ruling has significant implications for the ability of the FDA to regulate unproven stem cell-based interventions. Without sufficient regulatory oversight, marketers of unproven stem cell-based interventions are free to make exaggerated and unsupported claims about their products. Therefore, ISCT supports the U.S. government's position that stem cell-based interventions should be subject to the FDA's regulatory framework for drugs and biologics, so the safety and efficacy of new cell therapies must be proven in clinical trials before they can be marketed to protect the public from dangerous products.

ISCT submitted its brief as a long-standing advocate working to raise awareness about the dangers of unproven cellular interventions. With expert working groups and committees such as the ISCT Committee on the Ethics of Cell and Gene Therapy (ECGT), the Society works to voice sector-wide concerns to minimize risks and ensure patient benefit and safety continue to drive the translation of cell and gene therapies. 

The amicus brief is filed jointly by the International Society for Cell & Gene Therapy (ISCT) and the International Society for Stem Cell Research (ISSCR). Download the brief.

About the International Society for Cell & Gene Therapy

Established in 1992, the International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists, and industry partners with a shared vision to translate cell and gene therapy into safe and effective treatments to improve lives worldwide.

ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three critical areas of translation: Academia, Regulatory, and Commercialization. Through solid relationships with global regulatory agencies, academic institutions, and industry partners, ISCT drives the advancement of research into a standard of care.

Comprising over 3,000 cell and gene therapy experts across five geographic regions and with representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders, and organizations invested in cell and gene therapy translation. For more information about the society, key initiatives, and upcoming meetings, please visit https://isctglobal.org, @ISCTglobal.


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