CompletedNCT04382547Updated Aug 23, 2021

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

A Phase 1/2 interventional study of Allogenic pooled olfactory mucosa-derived mesenchymal stem cells and Standard treatment according to the Clinical protocols in COVID, Covid-19 and Coronavirus, sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus. Completed at 1 site in Belarus. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-23.

Sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 32
Allocation: Non-randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

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

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Keywords

pneumonia
Sars-COV2
Covid-19

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

PCR-confirmed Covid-19 pneumonia
respiratory failure

Exclusion criteria

Exclusion Criteria:

diagnosed cancer

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 32 participants (actual)

Study arms

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 · Other: 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

Interventions

BiologicalAllogenic pooled olfactory mucosa-derived mesenchymal stem cells
Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
OtherStandard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols

What researchers measure

Primary outcomes

Number of cured patients
Number of patients cured, assessed by PCR in addition to chest CT scan
Time frame: 3 weeks

Secondary outcomes

Number of patients with treatment-related adverse events
MSC infusion related adverse events assessed by blood count, liver and function tests
Time frame: 3 weeks

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04382547
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators: Belarusian State Medical University
Responsible party: Sponsor
First posted: May 11, 2020
Start date: May 11, 2020
Primary completion: Jun 30, 2021
Completion: Jun 30, 2021
Last update: Aug 23, 2021

Study contacts

Andrei Y Hancharou, Dr.

study director · Director, the Institute of Biophysics and Cell Engineering of NAS of Belarus

Eduard A Dotsenko, Dr., prof.

study director · Head of the chair, Belarusian State Medical University

Natalia G Antonevich, Dr.

principal investigator · Head of the Lab of Institute of Biophysics and Cell Engineering of NAS

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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