Pilot Study Comparing Alofisel and Autologous Fat Stem Cell Treatments for Complex Anal Fistulas in Crohn's Disease Patients

What this Trial Is About

Researchers are investigating two innovative treatments for complex anal fistulas associated with Crohn's disease. The study compares Alofisel, a cell therapy made from donor fat tissue stem cells, with autologous fat stem cell injections, which use the patient's own fat tissue. This research aims to evaluate the effectiveness of these two approaches in treating fistulas that have not responded well to conventional therapies. Participants scheduled for perianal surgery will receive either Alofisel or fat stem cell injections. Alofisel involves a single dose of 120 million mesenchymal stem cells derived from donor adipose tissue, while the alternative treatment uses injections of the patient's own adipose stem cells. Because Alofisel is costly and cannot be stored once thawed, two patients are paired for a single dose—one receives treatment and the other serves as a backup. Follow-up includes two visits: one shortly after surgery and another six months later. During these visits, researchers will assess fistula healing using clinical evaluations, analgesic use reports, and MRI imaging. The primary outcome measured is the effectiveness of Alofisel compared to fat grafting one month after surgery. Participants will be monitored for signs and history of their fistulas, with detailed assessments to understand treatment response and safety over time.

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