drugset / Trial / NCT04615429
Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS
RandomizedParallel-groupDouble-blindTreatment
Summary
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.
Timeline
- Start
- 2020-09-15
- Primary completion
- 2022-01-01
- Completion
- 2022-02-01
Publications
- Background Payares-Herrera C, Martinez-Munoz ME, Vallhonrat IL, de Molina RM, Torres MP, Trisan A, de Diego IS, Alonso R, Zafra R, Donaire T, Sanchez R, Rubio JJ, Duarte Palomino RF, Sola CA. Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 6;22(1):9. doi: 10.1186/s13063-020-04964-1.
- Martinez-Munoz ME, Payares-Herrera C, Lipperheide I, Malo de Molina R, Salcedo I, Alonso R, Martin-Donaire T, Sanchez R, Zafra R, Garcia-Berciano M, Trisan-Alonso A, Perez-Torres M, Ramos-Martinez A, Ussetti P, Rubio JJ, Avendano-Sola C, Duarte RF. Mesenchymal stromal cell therapy for COVID-19 acute respiratory distress syndrome: a double-blind randomised controlled trial. Bone Marrow Transplant. 2024 Jun;59(6):777-784. doi: 10.1038/s41409-024-02230-5. Epub 2024 Feb 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |