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This investigational cell therapy, developed by the Royan Institute, consists of autologous bone marrow-derived mesenchymal stromal cells (BM-MSCs) for the treatment of refractory fistulizing Crohn's disease. The therapy utilizes the immunomodulatory and regenerative properties of MSCs to suppress local inflammation and promote the closure of perianal fistula tracts. In clinical trials, the cells are administered via intra-fistula injection, often in conjunction with fibrin glue. A specific Phase 1 study by the institute also explored the co-administration of MSCs with autologous fibroblasts to potentially enhance tissue remodeling and healing in patients who have not responded to standard medical or biological therapies.
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