Overview

AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)

Status:
Withdrawn
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
To evaluate the role of allogeneic mesenchymal stem cells for treatment of perianal fistulizing Crohn disease. Twenty (20) Crohn's disease patients with complex or multiple perianal or rectovaginal fistulas will be included and will be scheduled to undergo peri-fistula injections after meeting all inclusion/exclusion criteria's at baseline. Following the Pilot Phase of four (4) subjects, sixteen (16) subjects are scheduled to undergo perianal injections and after meeting all inclusion/exclusion criteria's, will be evaluated at baseline.
Phase:
Phase 1
Details
Lead Sponsor:
Joshua M Hare