drugset / Trial / NCT04447833
Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome
NaSingle-groupOpen-labelTreatment
Summary
This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used synonymously in this protocol) support due to respiratory insufficiency with or without concomitant circulatory problems, will be included and treated with a single dose of KI-MSC-PL-205.
Timeline
- Start
- 2020-06-17
- Primary completion
- 2021-01-30
- Completion
- 2026-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KI-MSC-PL-205 | Cell therapy | 1e+06 cells/kg | — |
| Subject | KI-MSC-PL-205 | Cell therapy | 2e+06 cells/kg | — |