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

NCT07413978 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-02-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Changchun Tuohua Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhiyong Peng · Zhongnan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07413978 on ClinicalTrials.gov