Stem cell therapy for Crohn's fistulas: safety check ends early

NCT ID NCT04118088

Terminated Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested the long-term safety and effectiveness of a stem cell treatment called darvadstrocel (Alofisel) for people with Crohn's disease and complex anal fistulas. Researchers planned to give one injection of the stem cells and follow 53 participants over several visits, including MRI scans. The study was terminated early, so the full safety and benefit picture is incomplete.

What this could mean

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

Active substance

darvadstrocel (human stem cells)

What this could lead to

If successful, this could provide a safer, more effective way to treat complex anal fistulas in Crohn's disease, potentially reducing the need for surgery.

What could go wrong

The study was terminated early with only 53 participants, so results are limited. Stem cell treatments carry risks like allergic reactions, infection, or tumor formation, and long-term benefits are not proven.

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.

COMPLEX PERIANAL FISTULA CROHN'S DISEASE

Contacts and locations

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Locations

Akh Wien

Vienna, 1090, Austria
C.H.U. de Pontevedra

Pontevedra, 36071, Spain
CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti

Rennes, Ille-et-Vilaine, 35033, France
CHRU de Lille - Hopital Claude Huriez - Gastroenterologie

Lille, Nord, 59037, France
CHU AMIENS PICARDIE Site SUD Hepato-Gastroenterology

Amiens, Picardie, 80054, France
CHU de Nice - Hopital de l'Archet II - Gastro-Enterologie, Hepatologi

Nice, Alpes-Maritimes, 6202, France
Centre Hospitalier Lyon Sud - Gastroenterology

Pierre-Bénite, Rhone, 69495, France
Chaim sheba Medical Center

Tel Litwinsky, 5262000, Israel
Charite - Campus Benjamin Franklin

Berlin, 12200, Germany
Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France
H. Donostia

Donostia / San Sebastian, San Sebastian, 20014, Spain
H.C.U. de Valencia

Valencia, 46010, Spain
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

Jerusalem, 91120, Israel
Hospital Clinic de Barcelona

Barcelona, 8036, Spain
Hospital Universitari de Bellvitge

Barcelona, 8907, Spain
Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain
Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Nuestra Senora de la Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010, Spain
Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitario Vall d'Hebron

Barcelona, 8035, Spain
ISCARE a.s.

Prague, 190 00, Czechia
Klinikum Dresden, University Hospital Dresden

Dresden, Saxony, 1307, Germany
Krankenhaus Waldfriede

Berlin, 14163, Germany
NH Hospital a.s.

Hořovice, 268 31, Czechia
Paris St. Joseph Hospital

Paris, 75014, France
Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel
Shaare Zedek Medical Center

Jerusalem, 9103102, Israel
Stadtisches Klinikum Luneburg

Luneburg, Schleswig-Holstein, 21339, Germany
Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel