Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC) (NCT04543994) | Clinical Trial Compass
TerminatedPhase 1/2
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)
Stopped: PI left Cleveland Clinic
United States7 participantsStarted 2020-11-10
Plain-language summary
The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis.
This study will enroll adult patients with medically refractory ulcerative colitis who are planning to switch biologic therapy or undergo colectomy as the next stage in their treatment plan.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males and Females 18-75 years of age.
✓. Ulcerative colitis of at least 6 months duration with medically refractory symptoms
✓. Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 4 weeks for any monoclonal antibody is necessary.
✓. If receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks.
✓. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks.
✓. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks.
✓. If receiving oral corticosteroids, the dose must be ≤20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks.
✓. If receiving budesonide, the dose must have been stable for at least 2 weeks.
✕. 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 AST \>100 or ALT \> 100
✕. Abnormal basic laboratory values with the following cut-offs: