![FDA Seeks Injunctions in Fight Against $2.4bn Unapproved Stem Cell Market FDA Seeks Injunctions in Fight Against $2.4bn Unapproved Stem Cell Market](https://eu-images.contentstack.com/v3/assets/blt0a48a1f3edca9eb0/blt38209060ca01c576/658aefe4d66a6d040bfeb9bb/stem-cell-3283197d_273.jpg?width=1280&auto=webp&quality=95&format=jpg&disable=upscale)
Industry group International Society Cell and Gene Therapy (ISCT) has supported regulatory actions aimed at permanently closing two unapproved US stem cell clinics.
The US Food and Drug Administration (FDA) is seeking a permanent injunction against Sunrise, Florida-based US Stem Cell Clinic LLC and Californian firm California Stem Cell Treatment Center Inc for marketing stem cell products without approval.
The actions are the latest in a crackdown by the regulator on unproven cellular therapies (UCT) and complement a suite of new guidance documents issued last November aimed at detailing a science-based process for regenerative medicines.
“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk,” FDA commissioner Scott Gottlieb said.