Plain-English translation of NCT05039411 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing a treatment called PF2020-CELL (allogeneic human umbilical cord mesenchymal stem cells), which are healing cells collected from umbilical cord tissue after birth. Researchers want to see if injecting these cells directly around fistulas — painful tunnels that form in the skin as a result of Crohn's disease — can help them heal when standard medications haven't worked. The study will carefully monitor safety and watch for signs of healing.
Perianal fistulas are a serious complication of Crohn's disease that cause pain and infection, and many patients' fistulas don't respond well to current medical treatments. This trial is exploring whether the medication might offer a new option for patients who have not had success with other therapies.
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If you join this trial, you would receive five injections of stem cells over several months (spaced 6–12 weeks apart). Each injection involves a procedure where doctors clean out the fistula tract, close the inner opening, and then inject 60 million stem cells around the fistula. If your fistula heals completely before all five treatments, you can stop receiving injections — but you'll still come in for regular check-ups and tests for the rest of the study to make sure everything stays healthy.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
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