drugset / Trial / NCT04466098
Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a multi-center, randomized, placebo controlled, interventional phase 2A trial to evaluate the safety profile and potential efficacy of multi-dosing of mesenchymal stromal cells (MSC) for patients with SARS-CoV-2 associated Acute Respiratory Distress Syndrome (ARDS). After informed consent, treatment assignment will be made by computer-generated randomization to administer either MSC or vehicle placebo control with a 2:1 allocation to the MSC: placebo arm.
Timeline
- Start
- 2020-07-30
- Primary completion
- 2022-02-25
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 3e+08 cells | — |