The International Society for Cell & Gene Therapy (ISCT) has celebrated a significant legal victory in the case U.S. v. California Stem Cell Treatment Center, Inc.

This victory comes as the U.S. Court of Appeals for the Ninth Circuit reversed a previous district court decision, affirming the FDA's authority to regulate cell therapies.

In a unanimous ruling, the Ninth Circuit classified the defendants' stromal vascular fraction (SVF) mixture as a 'drug' under federal law.

This ruling ensures that the safety and effectiveness of cell therapy products will be evaluated under a proper regulatory framework.

The court also rejected the defendants' claim that their procedure was exempt from FDA regulation under the 'same surgical procedure' exception.

The ruling is particularly timely given the growing market for cell and gene therapies, which has seen an increase in unregulated clinics targeting vulnerable patients.

Bruce Levine, Chair of the ISCT Ethics of Cell and Gene Therapy Committee, praised the decision as a reaffirmation of the FDA's role in protecting patients.

ISCT, which comprises over 4,000 experts, collaborates with regulatory agencies, academia, and industry to advance research in cell and gene therapy.

Founded in 1992, ISCT is a global society dedicated to translating cell and gene therapy into safe and effective treatments.