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

August 20, 2021 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220072
        • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PCR-confirmed Covid-19 pneumonia
  • respiratory failure

Exclusion Criteria:

  • diagnosed cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mesenchymal stem cells
Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells
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
ACTIVE_COMPARATOR: control
Patients with Covid-19 associated pneumonia receiving standard treatment
Other: Standard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Belarusian State Medical University

Investigators

  • Study Director: Andrei Y Hancharou, Dr., Director, the Institute of Biophysics and Cell Engineering of NAS of Belarus
  • Study Director: Eduard A Dotsenko, Dr., prof., Head of the chair, Belarusian State Medical University
  • Principal Investigator: Natalia G Antonevich, Dr., Head of the Lab of Institute of Biophysics and Cell Engineering of NAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 11, 2020

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (ACTUAL)

May 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_MSC2(Covid)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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