BioSphincter

BioSphincter is an autologous bioengineered internal anal sphincter (IAS) implant developed by Cellf Bio LLC for the treatment of severe passive fecal incontinence. The therapy involves harvesting a patient's own smooth muscle cells and neural progenitor cells via intestinal biopsy, which are then cultured and bioengineered into a functional, ring-shaped sphincter construct. Once surgically implanted, the BioSphincter is designed to integrate with host tissue, restore physiological resting pressure, and establish neurological connections, thereby providing a long-term regenerative solution for fecal continence without the risk of immune rejection or the need for mechanical components. It is currently being evaluated in a Phase 1 first-in-human clinical trial.

Brand names

BioSphincter

Other names

Bioengineered Internal Anal SphincterAutologous Bioengineered Internal Anal Sphincter