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

Study Overview
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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.

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

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

Intervention / Treatment
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* Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
* Other: Standard treatment according to the Clinical protocols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCR-confirmed Covid-19 pneumonia respiratory failure Exclusion Criteria: diagnosed cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>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<br>* Allogenic pooled olfactory mucosa-derived mesenchymal stem cells<br>Other: Standard treatment according to the Clinical protocols<br>* Standard treatment according to the Clinical protocols<br>|
| Active Comparator: control<br>Patients with Covid-19 associated pneumonia receiving standard treatment | Other: Standard treatment according to the Clinical protocols<br>* Standard treatment according to the Clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cured patients | 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 | MSC infusion related adverse events assessed by blood count, liver and function tests | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, Sars-COV2, Covid-19