COVID-19 Acute Respiratory Distress SyndromeMSCNCT05240430
When to Apply to Which Patient in MSC?
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Mesenchymal stem cell (MSC) therapy is among the promising treatments for acute respiratory distress syndrome (ARDS). Our study aimed to investigate the clinical efficacy of MSC treatment in COVID-19 patients, to determine when this treatment can be applied to which patient, and to evaluate its contribution to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Mesenchymal Stem Cell Antigen-1, Human
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Mar 2022
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: COVID PCR positive * Those who received MSC treatment * Those with advanced respiratory failure * Those who have progressed despite the standard recommended (antiviral, steroid, anticoagulant and vitamin) supportive treatment
Who may be able to join
- Patients who were followed up and treated after being admitted to the Intensive Care Unit after March 2020
- Patients with COVID PCR +
- Typical or suspected cases of Thorax BT COVID
- Cases over the age of 18.
Who cannot join
- Those with a contraindicated condition (cancer disease, allergy) for MSC application
- Those who are endotracheal intubated during the application and are connected to a respirator
- Those who died in the first 24 hours after the application
- Cases that are not positive or suspicious for COVID.
- Cases under the age of 18.
- Cases where patient data could not be reached.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences
Trabzon, Yomra, 61500
Seyfi KARTAL, MD, +90462 341 5656, drseyfikartal@gmail.com
Esra Kongur, MD
About this study
Official title: Effectiveness of Mesenchymal Stem Cell in Patients With COVID-19 Associated SARS-CoV-2, Retrospective Clinical Study: When to Apply to Which Patient?
Mesenchymal stem cell (MSC) therapy is among the promising treatments for acute respiratory distress syndrome (ARDS). Our study aimed to investigate the clinical efficacy of MSC treatment in COVID-19 patients, to determine when this treatment can be applied to which patient, and to evaluate its contribution to prognosis.
Read the detailed description
The study was conducted retrospectively in patients diagnosis of COVID-19 in the intensive care units. Patients with severe ARDS [partial pressure of arterial blood oxygen and inhaled oxygen fraction (PaO2: FiO2) ratio of 100 or less] were included in the study. Demographic data of the patients (gender, age), comorbidities (hypertension, coronary heart disease, diabetes, cerebrovascular diseases, hepatitis B infection, cancer, chronic kidney disease, and immunodeficiency), Charlson comorbidity index (CMI), date of diagnosis, date of admission to the hospital, date of admission to the ICU, Acute Physiology And Chronic Health Evaluation (APACHE) II score, presence of high flow nasal oxygen (HFNO) or mechanical ventilator (MV) support, laboratory findings (blood cell count, blood biochemistry, hepatorenal function, coagulation function, D-dimer, C-reactive protein (CRP), procalcitonin, ferritin, arterial blood gas analysis) before (day 0) and after MSC application, on 3rd and 7th days, partial oxygen/fractionated oxygen (Pa/Fi) ratio, discharge or death information, and attributed causes of death were recorded on the study form. Pa/Fi ratio was calculated with the formula (oxygen dissolved in arterial blood gas / oxygen liter given to the patient).
- Being tested
- Mesenchymal Stem Cell Antigen-1, Human
- Keywords
- COVID-19, SARS-CoV-2, Mesenchymal Stem Cell, Intensive Care Units
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cell Antigen-1, HumanDrug
Also called Human umblical cord deriveted Mesenchymal Stem Cell
Human umbilical cord-derived MSCs were used in the study. MSCs were prepared/obtained/produced/provided by Atigen-Cell Technology Center, Trabzon, Turkey. MSC for patients was calculated as a single dose, 1x106 cells per kilogram. MSC was infused in 100 ml of normal saline at 2 ml/min over 40 min, as described in previous studies
| Study group | Role | What they receive |
|---|---|---|
| stem cell application; Group I disease 0-7. days, | In mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group I disease 0-7. days, Receives: Drug: Mesenchymal Stem Cell Antigen-1, Human | |
| stem cell application; Group II; 8-14 days of the disease. days | In mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group II; 8-14 days of the disease. days Receives: Drug: Mesenchymal Stem Cell Antigen-1, Human | |
| stem cell application; Group III; those applied on the 15th day and after. | In mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group III; It will be divided into 3 groups as those applied on the 15th day and after. Receives: Drug: Mesenchymal Stem Cell Antigen-1, Human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute phase reactants (C-reactive protein (CRP) after MSC administration in group I, II, III
It was aimed to observe the changes in C-reactive protein (CRP), after MSC administration at different times (groups 1,2,3).
Measured: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
Change in acute phase reactants (procalcitonin) after MSC administration in group I, II, III
It was aimed to observe the changes in procalcitonin after MSC administration at different times (groups 1,2,3).
Measured: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
Change in acute phase reactants ( white blood cell count) after MSC administration in group I, II, III
It was aimed to observe the changes in white blood cell count after MSC administration at different times (groups 1,2,3).
Measured: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
Changes in respiratory support after MSC administration in Groups I, II, III
It was aimed to observe the changes in respiratory support (such as high-flow nasal oxygen, mask with reservoir, and mechanical ventilation) after MSC administration at different times (groups 1,2,3).
Measured: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
Changes in arterial blood gas analysis (partial oxygen/fractionated oxygen (Pa/Fi) ratio) after MSC administration in Groups I, II, III
It was aimed to observe the changes in arterial blood gas analysis after MSC administration in Groups I, II, III.
Measured: MSC treatment before (day 0) and after MSC application, on 3rd and 7th days,
Secondary outcomes (1)
Effect on mortality after MSC administration in Groups I, II, III
The effect of MSC application at different times on mortality will be evaluated.
Measured: 7, 14 and 28 days after MSC application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jan 2022
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyfi KARTAL, MD, Trabzon Kanuni Education and Research Hospital
- Investigators
- Ahmet AKYOL, MD, Study chair, Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences, Trabzon, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240430
- Sponsor's protocol ID
- Trabzon Kanuni TRH
- Acronym
- MSC
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No personal data belonging to the participants were used.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mesenchymal Stem Cell in Patients With COVID-19 Associated SARS-CoV-2, Retrospective Clinical Study: When to Apply to Which Patient?
- ClinicalTrials.gov ID
- NCT05240430
- Acronym / sponsor ID
- MSC / Trabzon Kanuni TRH
- Keywords
- COVID-19, SARS-CoV-2, Mesenchymal Stem Cell, Intensive Care Units
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 15 Feb 2022 (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.
Mesenchymal stem cell (MSC) therapy is among the promising treatments for acute respiratory distress syndrome (ARDS). Our study aimed to investigate the clinical efficacy of MSC treatment in COVID-19 patients, to determine when this treatment can be applied to which patient, and to evaluate its contribution to prognosis.
Detailed description
The study was conducted retrospectively in patients diagnosis of COVID-19 in the intensive care units. Patients with severe ARDS [partial pressure of arterial blood oxygen and inhaled oxygen fraction (PaO2: FiO2) ratio of 100 or less] were included in the study. Demographic data of the patients (gender, age), comorbidities (hypertension, coronary heart disease, diabetes, cerebrovascular diseases, hepatitis B infection, cancer, chronic kidney disease, and immunodeficiency), Charlson comorbidity index (CMI), date of diagnosis, date of admission to the hospital, date of admission to the ICU, Acute Physiology And Chronic Health Evaluation (APACHE) II score, presence of high flow nasal oxygen (HFNO) or mechanical ventilator (MV) support, laboratory findings (blood cell count, blood biochemistry, hepatorenal function, coagulation function, D-dimer, C-reactive protein (CRP), procalcitonin, ferritin, arterial blood gas analysis) before (day 0) and after MSC application, on 3rd and 7th days, partial oxygen/fractionated oxygen (Pa/Fi) ratio, discharge or death information, and attributed causes of death were recorded on the study form. Pa/Fi ratio was calculated with the formula (oxygen dissolved in arterial blood gas / oxygen liter given to the patient).
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stem cell application; Group I disease 0-7. days, | – | Drug: Mesenchymal Stem Cell Antigen-1, HumanIn mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group I disease 0-7. days, |
| stem cell application; Group II; 8-14 days of the disease. days | – | Drug: Mesenchymal Stem Cell Antigen-1, HumanIn mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group II; 8-14 days of the disease. days |
| stem cell application; Group III; those applied on the 15th day and after. | – | Drug: Mesenchymal Stem Cell Antigen-1, HumanIn mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group III; It will be divided into 3 groups as those applied on the 15th day and after. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID PCR positive * Those who received MSC treatment * Those with advanced respiratory failure * Those who have progressed despite the standard recommended (antiviral, steroid, anticoagulant and vitamin) supportive treatment
Key inclusion criteria (4 listed)
- Patients who were followed up and treated after being admitted to the Intensive Care Unit after March 2020
- Patients with COVID PCR +
- Typical or suspected cases of Thorax BT COVID
- Cases over the age of 18.
Key exclusion criteria (6 listed)
- Those with a contraindicated condition (cancer disease, allergy) for MSC application
- Those who are endotracheal intubated during the application and are connected to a respirator
- Those who died in the first 24 hours after the application
- Cases that are not positive or suspicious for COVID.
- Cases under the age of 18.
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 |
|---|---|---|
| Mesenchymal Stem Cell Antigen-1, HumanAlso: Human umblical cord deriveted Mesenchymal Stem CellHuman umbilical cord-derived MSCs were used in the study. MSCs were prepared/obtained/produced/provided by Atigen-Cell Technology Center, Trabzon, Turkey. MSC for patients was calculated as a single dose, 1x106 cells per kilogram. MSC was infused in 100 ml of normal saline at 2 ml/min over 40 min, as described in previous studies | Drug | stem cell application; Group I disease 0-7. days,, stem cell application; Group II; 8-14 days of the disease. days, stem cell application; Group III; those applied on the 15th day and after. |
Primary outcome
Change in acute phase reactants (C-reactive protein (CRP) after MSC administration in group I, II, III
Time frame: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
It was aimed to observe the changes in C-reactive protein (CRP), after MSC administration at different times (groups 1,2,3).
Change in acute phase reactants (procalcitonin) after MSC administration in group I, II, III
Time frame: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
It was aimed to observe the changes in procalcitonin after MSC administration at different times (groups 1,2,3).
Change in acute phase reactants ( white blood cell count) after MSC administration in group I, II, III
Time frame: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
It was aimed to observe the changes in white blood cell count after MSC administration at different times (groups 1,2,3).
Changes in respiratory support after MSC administration in Groups I, II, III
Time frame: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after
It was aimed to observe the changes in respiratory support (such as high-flow nasal oxygen, mask with reservoir, and mechanical ventilation) after MSC administration at different times (groups 1,2,3).
Changes in arterial blood gas analysis (partial oxygen/fractionated oxygen (Pa/Fi) ratio) after MSC administration in Groups I, II, III
Time frame: MSC treatment before (day 0) and after MSC application, on 3rd and 7th days,
It was aimed to observe the changes in arterial blood gas analysis after MSC administration in Groups I, II, III.
1 secondary outcome
Effect on mortality after MSC administration in Groups I, II, III
Time frame: 7, 14 and 28 days after MSC application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Mesenchymal stem cells derived from perinatal tissues for treatment of critically ill COVID-19-induced ARDS patients: a case seriesLink provided by the sponsor.
- Treatment of severe COVID-19 with human umbilical cord mesenchymal stem cellsLink provided by the sponsor.
- Individual participant dataSharing planned: No. No personal data belonging to the participants were used.
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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.
Ahmet AKYOL, MD study chair
Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences, Trabzon, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Recep ERİN, MD (+90462 341 5656, erinrecep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acute phase reactants (C-reactive protein (CRP) after MSC administration in group I, II, III (time frame: MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after). The study lists 5 primary outcomes in all. 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 15 Feb 2022.