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

NCT04615429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-17

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Cristina Avendaño Solá

    lead OTHER

Principal Investigators

  • Rafael F Duarte, MD, PhD · Hematology Department. Hospital Universitario Puerta de Hierro

  • Cristina Avedano-Sola, MD, PhD · Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro

  • Juan J Rubio, MD, PhD · ICU. Hospital Universitario Puerta de Hierro

  • Rosa Malo, MD · Respiratory Medicine Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2022-01-01
Completion
2022-02-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615429 on ClinicalTrials.gov