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Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia

NCT04429763 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-12

No results posted yet for this study

Summary

The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world.

There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people.

It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.

Conditions

Interventions

BIOLOGICAL

Umbilical cord derived mesenchymal stem cells

One dosis of 1\*10\^6 cells/Kg

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Fundación Universitaria de Ciencias de la Salud

    collaborator OTHER

  • Hospital de San Jose

    collaborator OTHER

  • Hospital Infantil Universitario de San Jose

    collaborator OTHER

  • Trustem

    lead INDUSTRY

Principal Investigators

  • Guillermo Sánchez-Vanegas, MD, PhD · Fundación Universitaria de Ciencias de la Salud

  • Carlos Escobar-Soto, MD, PhD · Trustem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2020-09-30
Completion
2020-11-30

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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 NCT04429763 on ClinicalTrials.gov