Pilot Study Comparing Alofisel and Autologous Fat Stem Cell Injections for Treating Complex Anal Fistulas in Adults with Crohns Disease

What this Trial Is About

Researchers are investigating treatments for complex anal fistulas in adults with Crohns disease that have not responded well to conventional therapies. This study compares two innovative cell therapy approaches Alofisel, an allogeneic mesenchymal stem cell medicine derived from donor fat tissue, and autologous fat stem cell injections taken from the patients own fat. The goal is to assess which treatment is more effective for these difficult-to-treat fistulas. Participants scheduled for perianal surgery will receive either Alofisel injection or autologous fat stem cell injection as part of routine care. Only one patient in each pair receives Alofisel due to its high cost and storage limitations, while the other serves as a backup receiving fat stem cells. The study follows patients with two main visits one after surgery and another six months later. During follow-up visits, clinical evaluation of fistula healing, analgesic use, and MRI assessments will be conducted. The primary outcome measured is the effectiveness of Alofisel compared to fat grafting one month after surgery. This observational study involves routine care injections and monitoring to gather data on healing and treatment response over time.

Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells