Stem cell shot aims to heal painful Crohn's fistulas
NCT ID NCT04519671
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested whether injecting donor stem cells directly into fistulas (abnormal tunnels) could help people with Crohn's disease. The trial planned to enroll 25 adults but was terminated early. The goal was to check safety and see if the treatment could lead to complete healing of the fistulas.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor bone marrow stem cells
- What this could lead to
- If it works, this could offer a new way to help heal fistulas in people with Crohn's disease without major surgery.
- What could go wrong
- This was a very early, small trial that was terminated, so results are limited. Stem cell treatments can have risks like infection or rejection, and it's unclear if this approach is truly effective.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
25 people
The number who actually took part.
- Started
-
Nov 2020
- Finished
-
Nov 2022
- 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
-
18 to 75 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 Hide 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. Men and Women 18-75 years of age 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 (\>2 months) corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted 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 cancer including melanoma (with the exception of localized skin cancers) within one year of screening. 5. History of colorectal cancer within 5 years 6. Investigational drug within one month of treatment 7. Pregnant or breast feeding or trying to become pregnant. 8. Presence of a rectovaginal or perineal body fistula 9. Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment 10. Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment 11. Severe anal canal disease that is stenotic and requires dilation 12. 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
-
Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Other studies related to the condition(s) this trial covers.
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