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Completed

NCT Number: NCT04382547

Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells

Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells

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Key information

Conditions

COVID COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Lung Diseases, Interstitial Nidovirales Infections Pneumonia Pneumonia, Interstitial Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

About this study

During the implementation of the project, it is planned to develop a method for the treatment of severe covid-19 associated interstitial pneumonia using allogeneic mesenchymal stem cells. The positive outlook for the effectiveness of MSCs is due to the following:

  • knowledge of the leading role of immunopathogenetic mechanisms in the development of acute interstitial lung diseases and the pronounced immunomodulating properties of MSCs;
  • high tropism of MSCs to lung tissue when administered intravenously;
  • the ability of MSCs to stimulate tissue regeneration and the effective use of MSCs in the treatment of acute damage to the myocardium and kidneys, which will contribute to the treatment of multiple organ failure;
  • positive results of preclinical studies of the method of treatment of viral pneumonia in animals, and the first clinical studies in patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PCR-confirmed Covid-19 pneumonia
  • respiratory failure

Exclusion criteria

  • diagnosed cancer

Treatment and study plan

Allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Biological

Allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Standard treatment according to the Clinical protocols

Other

Standard treatment according to the Clinical protocols

Primary outcomes

  1. Number of cured patients

    Time frame: 3 weeks

    Number of patients cured, assessed by PCR in addition to chest CT scan

Secondary outcomes

  1. Number of patients with treatment-related adverse events

    Time frame: 3 weeks

    MSC infusion related adverse events assessed by blood count, liver and function tests

Sponsors and collaborators

Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Other Gov

Collaborators

  • Belarusian State Medical University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 11, 2020
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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