NCT05262829

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

A Single-arm, Open-label Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Moderate to Severe Crohn's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-arm, open 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 will be conducted as follows: a total of 40 patients will be recruited and will receive either MSC injection into the diseased intestinal mucosa or intravenous MSC injection + MSC injection into the diseased intestinal mucosa. The proportion of patients with clinical and endoscopic response or remission will be used as the primary evaluation for follow-up. The Crohn's disease activity index (CDAI) was used to assess the severity of CD disease, with CDAI \<150 considered to be in clinical remission; a decrease in CDAI ≥70 was considered to be clinically effective, also referred to as clinical response. Endoscopic response was defined as at least 50% improvement in the simplified endoscopic score for Crohn's disease (SES-CD) from baseline, and endoscopic remission was defined as a SES-CD score ≤2.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BIOLOGICAL	Human Umbilical Cord Mesenchymal Stem Cells	MSCs treatment by intestinal submucosal injection/MSCs treatment by intravenous drip + MSCs treatment by intestinal submucosal injection

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-08-31
• Completion: 2025-01-31
• First posted: 2022-03-02
• Last updated: 2023-02-17

Locations

1 site across 1 country: China