Plain-English translation of NCT04010526 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn Disease research guide →Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing a new approach to heal stubborn fistulas (abnormal tunnels under the skin) in people with Crohn's disease. The treatment uses autologous adipose-derived stromal vascular fraction with microfat — essentially, healing stem cells and regenerative factors collected from your own fat tissue and then injected directly into the fistula area. The goal is to help your body repair and close these painful fistulas when standard medical and surgical treatments haven't worked.
Some people with Crohn's disease develop complex fistulas around the anus that don't heal even with the best current medicines and surgeries. This new treatment aims to harness your body's own regenerative cells to promote healing and tissue repair in ways that existing treatments cannot.
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You would first undergo an examination under anesthesia so doctors can fully assess your fistulas using imaging (MRI). At a separate visit, doctors would collect a small amount of fat tissue using a minimally invasive procedure, process it to concentrate the healing stem cells, and then inject this material directly into your fistulas under local anesthesia. You would then be followed with clinical exams and MRI scans at week 24 (about 6 months) to see if your fistulas have closed. Half of participants will receive the active treatment, and half will receive a placebo injection, decided by chance.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
France