Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could stem cells heal painful fistulas in kids with Crohn's?

NCT ID NCT04791878

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested whether injecting stem cells from donated bone marrow could help heal perianal fistulas in teenagers with Crohn's disease. Six patients aged 13-17 received injections of 75 million stem cells directly into the fistula tract, with a possible second dose after 3 months. The main goal was to check safety, and the study was terminated before reaching its target of 10 participants.

What this could mean

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

Active substance
bone marrow derived mesenchymal stem cells
What this could lead to
If this approach is safe and effective, it could point toward a new way to heal fistulas in children with Crohn's disease without major surgery.
What could go wrong
This is a very early (phase 1) and small study that was terminated early, so we don't have enough data to know if it works. Stem cell injections can cause side effects like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Males and females aged 13-17 with a diagnosis of Crohn's disease for at least six months duration. 2. Single and Multi-tract Perianal fistula, with or without previous failed surgical repair. 3. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia 4. Ability to comply with protocol 5. Competent and able to provide written informed consent 6. Concurrent Crohn's-related therapies with stable doses corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted. 7. Agree to use birth control or abstinence to avoid pregnancy during the study Exclusion Criteria 1. Inability to give informed consent. 2. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the subject. 3. Specific exclusions: 1. Hepatitis B or C 2. HIV 3. Abnormal AST or ALT at screening (defined as \>/+2x ULN) 4. History of colon cancer in the past two years, or treatment for other cancers within the last 6 months. 5. Investigational drug within one month of treatment 6. Pregnant or breast feeding or trying to become pregnant. 7. Presence of a rectovaginal or perineal body fistula 8. Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment 9. Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment 10. Severe anal canal disease that is stenotic and requires dilation 11. Female participant unwilling to agree to use acceptable contraception methods during participation in study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Perianal fistula due to Crohn's disease (disorder) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States