drugset / Trial / NCT04390139

Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19

NCT04390139

Phase 1/2 Completed 26 enrolled Blood and Tissue Bank of Catalonia
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.

Timeline

Start
2020-05-13
Primary completion
2022-12-20
Completion
2022-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject WJ-MSC Cell therapy 1e+06 cells/kg Intravenous