drugset / Trial / NCT05262829
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate and Severe Crohn's Disease
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, single-arm, open-ended study to evaluate the efficacy and safety of human umbilical cord MSCs in the treatment of refractory moderate-to-severe Crohn's disease. The study protocol is either MSC injection into the patient's diseased intestinal mucosa or intravenous MSC injection + MSC injection into the patient's diseased intestinal mucosa. Follow-up time points were pre-treatment (week 0), week 4, week 8, week 12, and week 24 post-treatment, and the primary evaluation at follow-up was the number of subjects with clinical and endoscopic response or remission.
Timeline
- Start
- 2022-02-28
- Primary completion
- 2024-08-31
- Completion
- 2025-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1 cells/kg | Other |
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 60 cells | Other |