Could stem cells heal painful fistulas in kids with Crohn's?
NCT ID NCT04791878
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Nov 2023
- Lead sponsor
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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
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13 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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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
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Cleveland Clinic
Cleveland, Ohio, 44195, United States