drugset / Trial / NCT04548583
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prochymal® | Cell therapy | 1.5e+08 cells | Other |
| Subject | Prochymal® | Cell therapy | 3e+08 cells | Other |