Back to resultsTreatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
Primary Purpose
COVID, Covid-19, Coronavirus
Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Standard treatment according to the Clinical protocols
Sponsored by
About this trial
This is an interventional treatment trial for COVID focused on measuring pneumonia, Sars-COV2, Covid-19
Eligibility Criteria
Inclusion Criteria:
- PCR-confirmed Covid-19 pneumonia
- respiratory failure
Exclusion Criteria:
- diagnosed cancer
Sites / Locations
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mesenchymal stem cells
control
Arm Description
Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Patients with Covid-19 associated pneumonia receiving standard treatment
Outcomes
Primary Outcome Measures
Number of cured patients
Number of patients cured, assessed by PCR in addition to chest CT scan
Secondary Outcome Measures
Number of patients with treatment-related adverse events
MSC infusion related adverse events assessed by blood count, liver and function tests
Full Information
NCT ID
NCT04382547
First Posted
May 8, 2020
Last Updated
August 20, 2021
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04382547
Brief Title
Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
Official Title
Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Covid-19, Coronavirus, Pneumonia, Pneumonia, Viral, Pneumonia, Interstitial, Sars-CoV2
Keywords
pneumonia, Sars-COV2, Covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Arm Title
control
Arm Type
Active Comparator
Arm Description
Patients with Covid-19 associated pneumonia receiving standard treatment
Intervention Type
Biological
Intervention Name(s)
Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Intervention Description
Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Intervention Type
Other
Intervention Name(s)
Standard treatment according to the Clinical protocols
Intervention Description
Standard treatment according to the Clinical protocols
Primary Outcome Measure Information:
Title
Number of cured patients
Description
Number of patients cured, assessed by PCR in addition to chest CT scan
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Number of patients with treatment-related adverse events
Description
MSC infusion related adverse events assessed by blood count, liver and function tests
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PCR-confirmed Covid-19 pneumonia
respiratory failure
Exclusion Criteria:
diagnosed cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Y Hancharou, Dr.
Organizational Affiliation
Director, the Institute of Biophysics and Cell Engineering of NAS of Belarus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eduard A Dotsenko, Dr., prof.
Organizational Affiliation
Head of the chair, Belarusian State Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Natalia G Antonevich, Dr.
Organizational Affiliation
Head of the Lab of Institute of Biophysics and Cell Engineering of NAS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
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