drugset / Trial / NCT05886985
Safety, Tolerability, and Efficacy of MatriPlax in Subjects With Acute Respiratory Distress Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MatriPlax | Cell therapy | 2e+07 cells | Intravenous |
| Subject | MatriPlax | Cell therapy | 4e+07 cells | Intravenous |
| Subject | MatriPlax | Cell therapy | 8e+07 cells | Intravenous |