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

Phase 1

Completed

• Conditions: COVID; Coronavirus; Pneumonia; Pneumonia, Viral; Covid-19; Pneumonia, Interstitial; Sars-CoV2
• Interventions: Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells; Other: Standard treatment according to the Clinical protocols

• Registration Number: NCT04382547
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study Start: 2020-05-11
• Study First Posted: 2020-05-11
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• PCR-confirmed Covid-19 pneumonia
• respiratory failure

Exclusion Criteria

• diagnosed cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	Standard treatment according to the Clinical protocols	Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells
mesenchymal stem cells	Allogenic pooled olfactory mucosa-derived mesenchymal stem cells	Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells
control	Standard treatment according to the Clinical protocols	Patients with Covid-19 associated pneumonia receiving standard treatment

Primary Outcome Measures

Name	Time	Method
Number of cured patients	3 weeks	Number of patients cured, assessed by PCR in addition to chest CT scan

Secondary Outcome Measures

Name	Time	Method
Number of patients with treatment-related adverse events	3 weeks	MSC infusion related adverse events assessed by blood count, liver and function tests

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus