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

NCT ID NCT05113095

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Takeda selected site

    RECRUITING

    Tokyo, Tokyo, Japan