drugset / Trial / NCT07413978
A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-04-25
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 5e+07 cells | Other |
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1e+08 cells | Other |
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1.5e+08 cells | Other |
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 2e+08 cells | Other |