Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease

Stopped early · Phase 1

Conditions studied: Perianal Fistula Due to Crohn's Disease (Disorder)

In brief

This study plans to enroll 10 patients aged 13-17 years of age with refractory perianal fistulizing disease. Patients will be treated by direct injection to the fistula tract(s) with 75 million allogeneic bone marrow derived mesenchymal stem cells at baseline and again after 3 months if not completely healed.

Key facts

Study ID

NCT04791878

Run by

Anthony Lembo

People needed

6

Starts

2021-04-01

Expected to finish

2023-11-01

Last updated by the study team

2026-04-16

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged 13-17 with a diagnosis of Crohn's disease for at least six months duration.
• Single and Multi-tract Perianal fistula, with or without previous failed surgical repair.
• Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
• Ability to comply with protocol
• Competent and able to provide written informed consent
• Concurrent Crohn's-related therapies with stable doses corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted.
• Agree to use birth control or abstinence to avoid pregnancy during the study

You may not qualify if…

• Inability to give informed consent.
• 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.
• Specific exclusions:
• Hepatitis B or C
• HIV
• Abnormal AST or ALT at screening (defined as >/+2x ULN)
• History of colon cancer in the past two years, or treatment for other cancers within the last 6 months.
• Investigational drug within one month of treatment
• Pregnant or breast feeding or trying to become pregnant.
• Presence of a rectovaginal or perineal body fistula
• Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment
• Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment
• Severe anal canal disease that is stenotic and requires dilation
• Female participant unwilling to agree to use acceptable contraception methods during participation in study

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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