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This investigational autologous cell therapy consists of expanded adipose-derived mesenchymal stem cells (ASCs) combined with fibrin glue. Developed by the Health Research Institute Fundación Jiménez Díaz (FIIS-FJD), it is specifically designed for the treatment of complex cryptoglandular perianal fistulas in patients without inflammatory bowel disease (non-IBD). The treatment involves harvesting the patient's own adipose tissue, expanding the mesenchymal stem cells in vitro using human platelet lysate, and then injecting 100 million expanded cells into the fistula tract along with fibrin glue. The fibrin glue acts as a biological scaffold and sealant, while the ASCs provide immunomodulatory and pro-regenerative signals to promote tissue healing and re-epithelialization of the fistula tract. Long-term follow-up from the Phase 3 FISPAC trial demonstrated significantly higher healing rates compared to fibrin glue alone.
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