Status:
UNKNOWN
Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease
Lead Sponsor:
Amy Lightner
Conditions:
Perianal Crohn Disease
Perianal Fistula
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 fistuli...
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
- 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
- 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 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
Exclusion
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04519671
Start Date
November 19 2020
End Date
November 1 2022
Last Update
April 5 2022
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195