COVIDPhase 1/2NCT04382547
Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
A Phase 1/2 study testing Allogenic pooled olfactory mucosa-derived mesenchymal stem cells and Standard treatment according to the Clinical protocols in people with COVID and Covid-19, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID, Covid-19, Coronavirus
- What is being tested?
- Allogenic pooled olfactory mucosa-derived mesenchymal stem cells and Standard treatment according to the Clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelarus
- Study dates
- 11 May 2020to 30 Jun 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCR-confirmed Covid-19 pneumonia
- respiratory failure
Who cannot join
- diagnosed cancer
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
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
- COVID, Covid-19, Coronavirus, Pneumonia, Pneumonia, Viral, Pneumonia, Interstitial
- Being tested
- Allogenic pooled olfactory mucosa-derived mesenchymal stem cells, Standard treatment according to the Clinical protocols
- Keywords
- pneumonia, Sars-COV2, Covid-19
- Medical subject headings
- COVID-19, Coronavirus Infections, Pneumonia, Pneumonia, Viral, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic pooled olfactory mucosa-derived mesenchymal stem cellsBiological
Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Standard treatment according to the Clinical protocolsOther
Standard treatment according to the Clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells Receives: Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells; Other: Standard treatment according to the Clinical protocols |
| control | Active comparator | Patients with Covid-19 associated pneumonia receiving standard treatment Receives: Other: Standard treatment according to the Clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cured patients
Number of patients cured, assessed by PCR in addition to chest CT scan
Measured: 3 weeks
Secondary outcomes (1)
Number of patients with treatment-related adverse events
MSC infusion related adverse events assessed by blood count, liver and function tests
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start11 May 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Andrei Y Hancharou, Dr., Study director, Director, the Institute of Biophysics and Cell Engineering of NAS of BelarusEduard A Dotsenko, Dr., prof., Study director, Head of the chair, Belarusian State Medical UniversityNatalia G Antonevich, Dr., Principal investigator, Head of the Lab of Institute of Biophysics and Cell Engineering of NAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382547
- Sponsor's protocol ID
- IBCE_MSC2(Covid)
- Status last verified
- Aug 2021
- First submitted
- 8 May 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04382547
- Acronym / sponsor ID
- IBCE_MSC2(Covid)
- Conditions
- COVID, Covid-19, Coronavirus, Pneumonia, Pneumonia, Viral, Pneumonia, Interstitial
- Keywords
- pneumonia, Sars-COV2, Covid-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 11 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cells, Other: Standard treatment according to the Clinical protocolsPatients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells |
| control | Active comparator | Other: Standard treatment according to the Clinical protocolsPatients with Covid-19 associated pneumonia receiving standard treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PCR-confirmed Covid-19 pneumonia
- respiratory failure
Key exclusion criteria (1 listed)
- diagnosed cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogenic pooled olfactory mucosa-derived mesenchymal stem cellsAllogenic pooled olfactory mucosa-derived mesenchymal stem cells | Biological | mesenchymal stem cells |
| Standard treatment according to the Clinical protocolsStandard treatment according to the Clinical protocols | Other | control, mesenchymal stem cells |
Primary outcome
Number of cured patients
Time frame: 3 weeks
Number of patients cured, assessed by PCR in addition to chest CT scan
1 secondary outcome
Number of patients with treatment-related adverse events
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogenic pooled olfactory mucosa-derived mesenchymal stem cells and Standard treatment according to the Clinical protocols in people with COVID and Covid-19, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cured patients (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.