drugset / Trial / NCT04625738

Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respiratory Distress Syndrome

NCT04625738 ↗

Phase 2 Completed 30 enrolled Central Hospital, Nancy, France
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties. The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10\^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.

Timeline

Start
2020-11-06
Primary completion
2021-05-14
Completion
2021-09-01

Outcome

Missed primary endpoint

paper We did not find any significant difference in the PaO2/FiO2 ratio at day 10, with 18 and 15% of WJ-MSCs and placebo-treated patients reaching a ratio >200, respectively. PMID 37706025 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Wharton's Jelly Mesenchymal Stem Cells Cell therapy 0.5 cells/kg Intravenous