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Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stem Cells

NCT04361942 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-02

No results posted yet for this study

Summary

Novel coronavirus disease COVID-19, produced by SARS-CoV-2, has become a health emergency around the world. Since first patients were detected in Wuhan (China), in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Fever, dry cough, shortness of breath and breathing distress are the main characteristics of COVID-19 infection. Some patients develop overwhelming lung inflammation and acute respiratory failure, for which there is no specific therapy. Therefore, safe and effective treatment for COVID-19 pneumonia is utterly necessary, mainly in critical cases. Mesenchymal stem/stromal cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. These immunomodulatory properties of MSCs support performance of the double-blind, placebo-controlled, randomized, phase I/II clinical trial to evaluate safety and efficacy of allogeneic MSCs for treatment of severe COVID-19 pneumonia.

Conditions

Interventions

BIOLOGICAL

Mesenchymal Stem Cells (MSCs)

Intravenous injection of 1 million MSCs (MSV cells)/Kg suspended in 100 ml physiological saline solution.

OTHER

Placebo

Intravenous injection of 100 ml physiological saline solution containing no cells

Sponsors & Collaborators

  • Citospin

    collaborator INDUSTRY

  • University of Valladolid

    collaborator OTHER

  • Castilla-León Health Service

    collaborator OTHER

  • Hospital del Rio Hortega

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Red de Terapia Celular

    lead INDUSTRY

Principal Investigators

  • Julia Barbado, MD, PhD · University Hospital Río Hortega, Valladolid, Spain

  • Rosa Conde, PhD · University Hospital Río Hortega, Valladolid, Spain

  • Margarita González-Vallinas, PhD · University of Valladolid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-10-28
Completion
2021-10-28

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 NCT04361942 on ClinicalTrials.gov