drugset / Trial / NCT05886985

Safety, Tolerability, and Efficacy of MatriPlax in Subjects With Acute Respiratory Distress Syndrome

NCT05886985 ↗

Phase 1 Not yet recruiting 24 enrolled BioSpring Medical Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to explore the safety, tolerability, and efficacy in study intervention, MatriPlax, in subjects with Acute Respiratory Distress Syndrome (ARDS). MatriPlax contains placenta choriodecidual membrane-derived Mesenchymal Stem Cells (pcMSCs). Participants will receive two doses of MatriPlax on Day 1 and Day 4 and conduct efficacy and safety evaluations until 12 months after treatment or withdrawal from the study.

Timeline

Start
2023-12
Primary completion
2026-12
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject MatriPlax Cell therapy 2e+07 cells Intravenous
Subject MatriPlax Cell therapy 4e+07 cells Intravenous
Subject MatriPlax Cell therapy 8e+07 cells Intravenous