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

NCT ID: NCT04382547

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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COVID Covid-19 Coronavirus Pneumonia Pneumonia, Viral Pneumonia, Interstitial Sars-CoV2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesenchymal stem cells

Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Group Type EXPERIMENTAL

Allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Standard treatment according to the Clinical protocols

control

Patients with Covid-19 associated pneumonia receiving standard treatment

Group Type ACTIVE_COMPARATOR

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Standard treatment according to the Clinical protocols

Interventions

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Allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Standard treatment according to the Clinical protocols

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* PCR-confirmed Covid-19 pneumonia
* respiratory failure

Exclusion Criteria

* diagnosed cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrei Y Hancharou, Dr.

Role: STUDY_DIRECTOR

Director, the Institute of Biophysics and Cell Engineering of NAS of Belarus

Eduard A Dotsenko, Dr., prof.

Role: STUDY_DIRECTOR

Head of the chair, Belarusian State Medical University

Natalia G Antonevich, Dr.

Role: PRINCIPAL_INVESTIGATOR

Head of the Lab of Institute of Biophysics and Cell Engineering of NAS

Locations

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

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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IBCE_MSC2(Covid)

Identifier Type: -

Identifier Source: org_study_id

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