drugset / Trial / NCT05262829

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate and Severe Crohn's Disease

NCT05262829

Unknown 40 enrolled Shanghai East Hospital
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

EvaluationDrugModalityDoseRoute
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

Indications