Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Perianal Crohn Disease, Perianal Fistula, Crohn Disease

In brief

The purpose of this study is to determine the safety and efficacy of using adult allogeneic bone marrow derived mesenchymal stem cells (MSCs), to treat people for medically refractory perianal fistulizing Crohn's disease.

Key facts

Study ID

NCT04519671

Run by

Anthony Lembo

People needed

25

Starts

2020-11-19

Expected to finish

2022-11-16

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and Women 18-75 years of age 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 (>2 months) corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted

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 cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
• History of colorectal cancer within 5 years
• 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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