Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula

This study is testing a stem cell therapy using fat-derived stem cells to treat complex anal fistulas in people with Crohn's disease. An anal fistula is an abnormal tunnel connecting the inside of the bowel to the skin near the anus — it's a painful and hard-to-treat complication of Crohn's. This cell therapy (allogeneic adipose-derived stem cells) has shown early promise and the study is testing different dose levels. **You may be eligible if...** - You are over 18 with a confirmed Crohn's disease diagnosis for more than 3 months - You have a complex anal fistula (with up to 2 internal and 3 external openings) - Your Crohn's intestinal disease is controlled (Harvey-Bradshaw score of 8 or less) - You have already tried standard treatment (drainage surgery combined with anti-TNF biologic therapy) for at least 6 months without success - Your rectum shows no active ulceration on a recent colonoscopy **You may NOT be eligible if...** - You have had a positive tuberculosis test - You have had an organ transplant - You have had cancer in the past 5 years or a blood cancer at any time - You have an active uncontrolled infection - You cannot have an MRI or are allergic to gadolinium or albumin - You are pregnant, breastfeeding, or a woman of childbearing age without effective contraception - You have previously been treated with the commercial version of this therapy (ALOFISEL) Talk to your doctor to see if this trial is right for you.