NCT06505941

Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS

Clinical Study on the Safety and Preliminary Efficacy of Umbilical Cord Mesenchymal Stem Cell Intravenous Infusion Therapy for Acute Respiratory Distress Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.

Detailed description

The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. Phase One is an open-label, dose-escalation clinical study. Following safety and tolerability conclusions from Phase One, and upon evaluation and approval by the data safety committee and ethics committee, conduct Phase Two study, which will be a randomized, double-blind, placebo-controlled study. Dosage selection will be based on the safest and most effective dosage determined from Phase One results.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	umbilical cord mesenchymal stem cell	umbilical cord mesenchymal stem cell
DRUG	Placebo	non-cell-containing placebo

Timeline

• Start date: 2024-07-20
• Primary completion: 2025-11-20
• Completion: 2027-02-20
• First posted: 2024-07-17
• Last updated: 2024-07-17