drugset / Trial / NCT04548583

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis

NCT04548583

Phase 1/2 Terminated 7 enrolled The Cleveland Clinic Mesoblast, Inc. · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2020-11-04
Primary completion
2023-11-15
Completion
2023-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Prochymal® Cell therapy 1.5e+08 cells Other
Subject Prochymal® Cell therapy 3e+08 cells Other

Indications