Experimental injection aims to heal painful fistulas in kids with Crohn's

NCT ID NCT04701411

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a treatment called darvadstrocel for children with Crohn's disease who have complex perianal fistulas (abnormal tunnels near the anus). Seven participants received an injection of the treatment near the fistula after a cleaning procedure. The goal was to see if the fistulas would close and stay closed for up to a year. However, the study was stopped early, so we have very little data on how well it works.

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 cell therapy injection near the fistula)

What this could lead to

If it works, this could offer a new way to close complex fistulas in children with Crohn's disease, potentially reducing pain and infections.

What could go wrong

The trial was terminated early with only 7 participants, so results are very limited. It is unclear if the treatment is effective or safe in children.

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

Locations

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ, Netherlands

  • Erasmus Medisch Centrum

    Rotterdam, 3000 CA, Netherlands

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, 35-302, Poland

  • Hadassah University Hospital-Mt. Scopus

    Jerusalem, 9124001, Israel

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009, Spain

  • Hospital Materno-Infantil de Malaga

    Málaga, 29011, Spain

  • Hospital Sant Joan de Deu

    Barcelona, 8950, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 8916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-730, Poland

  • Jichi Medical University Hospital

    Shimotsuke-shi, 329-0498, Japan

  • Juntendo University Hospital

    Bunkyō City, 113-8431, Japan

  • Medical Hospital, Tokyo Medical and Dental University

    Bunkyō City, 113-8519, Japan

  • Mie University Hospital

    Tsu, 514-8507, Japan

  • Miyagi Children's Hospital

    Sendai, 989-3126, Japan

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Shaare Zedek Medical Center

    Jerusalem, 91031, Israel

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov, 7033001, Israel

  • Universitair Medisch Centrum Groningen (UMCG)

    Groningen, 9713 GZ, Netherlands

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30-663, Poland