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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382547
Recruitment Status : Completed
First Posted : May 11, 2020
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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

Condition or disease Intervention/treatment Phase
COVID Covid-19 Coronavirus Pneumonia Pneumonia, Viral Pneumonia, Interstitial Sars-CoV2 Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells Other: Standard treatment according to the Clinical protocols Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
Actual Study Start Date : May 11, 2020
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of cured patients [ Time Frame: 3 weeks ]
    Number of patients cured, assessed by PCR in addition to chest CT scan


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCR-confirmed Covid-19 pneumonia
  • respiratory failure

Exclusion Criteria:

  • diagnosed cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382547


Locations
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Belarus
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, Belarus, 220072
Sponsors and Collaborators
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Belarusian State Medical University
Investigators
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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
More Information
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Responsible Party: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
ClinicalTrials.gov Identifier: NCT04382547    
Other Study ID Numbers: IBCE_MSC2(Covid)
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus:
pneumonia
Sars-COV2
Covid-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Viral
Lung Diseases, Interstitial
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases