Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Crohn Colitis
In brief
Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon. Up to two thirds will become medically refractory and require a total abdominal colectomy for symptom control. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory Crohn's colitis.
Key facts
- Study ID
- NCT04548583
- Run by
- The Cleveland Clinic
- People needed
- 7
- Starts
- 2020-11-04
- Expected to finish
- 2023-11-15
- 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 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 patient.
- Specific exclusions;
- HIV
- Hepatitis B or C
- Abnormal AST or ALT at screening defined as > 3x upper limit of normal?
- History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
- Investigational drug within one year of study enrollment
- Pregnant or breast feeding.
- If patient is of reproductive capacity, unwilling to use adequate birth control measures while they are in the study
- Fulminant colitis requiring emergency surgery
- Concurrent active clostridium difficile infection of the colon
- Concurrent CMV infection of the colon
- Evidence of colonic perforation
- Massive hemorrhage from the colon requiring emergent surgery
- Ulcerative colitis or indeterminate colitis
- Neoplasia of the colon on preoperative biopsy
- Presence of an ostomy
- Three or more prior small bowel resections
- Colonic stricture that unable to pass an adult colonoscope
- Active or latent tuberculosis
- Unable to wean off corticosteroids
- Patients with primary sclerosing cholangitis
- Patients with a known allergy to DMSO, porcine and/or bovine proteins. Control patients will have additional criteria that need to be met prior to the patients' crossing over to receive treatment.
- Inclusion Criteria for control patients prior to entering the treatment phase:
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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