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RECRUITING
NCT07413978
PHASE1/PHASE2

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

Sponsor: Changchun Tuohua Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-04-25

Completion Date

2028-12-31

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China