The International Society for Cell & Gene Therapy (ISCT), established in 1992, focuses on advancing safe and effective cell and gene therapies.

The recent ruling by the U.S. Court of Appeals for the Ninth Circuit comes at a time when the market for cell and gene therapies is expanding, leading to an increase in unregulated clinics that target vulnerable patients.

In a significant legal victory, the Ninth Circuit ruled in favor of the FDA, reversing a previous district court decision.

The court unanimously determined that a specific stromal vascular fraction (SVF) mixture, which includes liquified cells and debris, qualifies as a drug under the Federal Food, Drug, and Cosmetic Act.

This ruling reaffirms the FDA's authority to regulate cell therapies, ensuring that safety and effectiveness evaluations are conducted for patient products.

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

In support of the U.S. government's appeal, ISCT filed an amicus curiae brief in June 2024.

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