Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Enrolling by invitation
First Posted : May 11, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location information
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
Layout table for investigator information
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
Layout table for additonal information
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: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Pneumonia, Viral
Pneumonia
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases