Stem cell injection aims to heal tough fistulas in Crohn's patients

NCT ID NCT05113095

Recruiting now Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 275 Crohn's disease patients in Japan who receive darvadstrocel, a stem cell injection, for complex anal fistulas. Researchers will monitor side effects and whether fistulas close over 36 months. The goal is to see if this treatment is safe and works in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: darvadstrocel (a stem cell injection)
What this could lead to: If successful, this could confirm darvadstrocel as a safe and effective option to close complex anal fistulas in Crohn's disease, reducing symptoms and improving quality of life.
What could go wrong: This is an observational registry, not a controlled trial, so results may be less definitive. Side effects or lack of lasting benefit are possible, and findings may not apply outside Japan.

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Conditions

The condition(s) this trial relates to.

anal fistula Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CROHN'S DISEASE

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Takeda selected site
RECRUITING

Tokyo, Tokyo, Japan

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