NCT07413978

A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome

A Phase I-II, Open-label, Single-arm, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Changchun Tuohua Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Exploratory Objective: To explore the immunogenicity and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate/severe acute respiratory distress syndrome.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	1 vial containing a total of 5×10^7 cells	venous reinfusion
BIOLOGICAL	2 vial containing a total of 1×10^8 cells	venous reinfusion
BIOLOGICAL	3 vial containing a total of 1.5×10^8 cells	venous reinfusion
BIOLOGICAL	4 vial containing a total of 2×10^8 cells	venous reinfusion

Timeline

• Start date: 2025-04-25
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China