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NCT04382547 Clinical Trial

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

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04382547
Other study ID # IBCE_MSC2(Covid)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 11, 2020
Est. completion date June 30, 2021

Study information
Verified date August 2021
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - PCR-confirmed Covid-19 pneumonia - respiratory failure Exclusion Criteria: - diagnosed cancer

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belarus Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk

Sponsors (2)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of cured patients Number of patients cured, assessed by PCR in addition to chest CT scan 3 weeks
Secondary Number of patients with treatment-related adverse events MSC infusion related adverse events assessed by blood count, liver and function tests 3 weeks
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