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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2021

Detailed Description

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.

Interventions

  • Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
    • Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
  • Other: Standard treatment according to the Clinical protocols
    • Standard treatment according to the Clinical protocols

Arms, Groups and Cohorts

  • Experimental: mesenchymal stem cells
    • Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells
  • Active Comparator: control
    • Patients with Covid-19 associated pneumonia receiving standard treatment

Clinical Trial Outcome Measures

Primary Measures

  • Number of cured patients
    • Time Frame: 3 weeks
    • Number of patients cured, assessed by PCR in addition to chest CT scan

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • PCR-confirmed Covid-19 pneumonia
  • respiratory failure

Exclusion Criteria

  • diagnosed cancer

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
  • Collaborator
    • Belarusian State Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrei Y Hancharou, Dr., Study Director, Director, the Institute of Biophysics and Cell Engineering of NAS of Belarus
    • Eduard A Dotsenko, Dr., prof., Study Director, Head of the chair, Belarusian State Medical University
    • Natalia G Antonevich, Dr., Principal Investigator, Head of the Lab of Institute of Biophysics and Cell Engineering of NAS

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