Plain-English translation of NCT06925594 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn's Disease research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing a treatment called TH-SC01 cell injection for people with Crohn's disease who have developed anal fistulas—painful abnormal tunnels that form near the anus. Half of the participants will receive an injection of 120 million specially grown human cells directly into the fistula, while the other half will receive a saline placebo injection. The trial will follow participants for 24 weeks to see if the medication can help these fistulas heal.
Anal fistulas are a common and difficult complication of Crohn's disease that often don't heal well with standard treatments and can require surgery. This trial exists to see whether cell-based therapy might offer a new, less invasive option for people struggling with this painful problem.
You likely qualify if…
You likely don't qualify if…
If you qualify, you will receive a single intralesional injection—a shot delivered directly into the fistula area under anesthesia. You'll then visit the clinic for follow-up assessments over 24 weeks (about 6 months) to monitor how well the fistula is healing. During this time, your doctor will use physical exams and MRI scans to track whether the treatment is working.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
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