NCT04615429

Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS

Double-blind, Randomized, Controlled, Clinical Trial to Assess the Efficacy of Allogenic Mesenchymal Stromal Cells in Patients With Acute Respiratory Distress Syndrome Due to COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cristina Avendaño Solá · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. All trial participants will receive SOC\*. Randomization will be 1:1 between: * Treatment arm: allogenic MSC. * Control arm: Placebo (solution with the same composition as the experimental treatment, without the MSC). * SOC can include any medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.).

Conditions

• Acute Respiratory Distress Syndrome
• COVID-19 Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stromal cells	Administration of one single dose of allogenic Mesenchymal stromal cells
OTHER	Placebo	Administration of placebo (solution identical to experimental treatment, without the MSC)

Timeline

• Start date: 2020-09-15
• Primary completion: 2022-01-01
• Completion: 2022-02-01
• First posted: 2020-11-04
• Last updated: 2026-03-17
• Results posted: 2026-03-17

Locations

1 site across 1 country: Spain