Status:
UNKNOWN
Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease
Lead Sponsor:
Amy Lightner
Conditions:
Perianal Fistula Due to Crohn's Disease (Disorder)
Eligibility:
All Genders
13-17 years
Phase:
PHASE1
Brief Summary
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 alloge...
Detailed Description
Crohn's disease (CD), a chronic transmural inflammatory disease of the gastrointestinal tract, continues to increase in incidence for unknown reasons. According to population based studies, at least 2...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04791878
Start Date
April 1 2021
End Date
April 1 2023
Last Update
April 5 2022
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195