NCT06882811

Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

Clinical Study on Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Sepsis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 0 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective: To evaluate the efficacy of intravenous infusion of universal UC-MSCs and CD83+MSCs subpopulation injection in the treatment of sepsis by using the 28-day survival rate of the subjects as the primary efficacy criterion.The secondary objectives: 1. To systematically evaluate the safety of universal UC-MSCs and CD83+MSCs subpopulation in the treatment of sepsis; 2. To provide theoretical basis and clinical research data for establishing a safe, effective and feasible clinical treatment plan for sepsis using stem cells.

Conditions

• Sepsis

Interventions

Type	Name	Description
BIOLOGICAL	CD83-positive MSC	90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
BIOLOGICAL	regulatory MSC	45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
OTHER	control solution	45 patients are infused with equal volume of control solution and receive regulatory treatment

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-03-19
• Last updated: 2025-05-25

Locations

1 site across 1 country: China