- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05240430
When to Apply to Which Patient in MSC? (MSC)
February 13, 2022 updated by: Seyfi KARTAL, MD, Trabzon Kanuni Education and Research Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Recep ERİN, MD
- Phone Number: +90462 341 5656
- Email: erinrecep@gmail.com
Study Contact Backup
- Name: Seyfi KARTAL, MD
- Phone Number: +904623415656
- Email: drseyfikartal@gmail.com
Study Locations
-
-
Yomra
-
Trabzon, Yomra, Turkey, 61500
- Recruiting
- Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences
-
Contact:
- Seyfi KARTAL, MD
- Phone Number: +90462 341 5656
- Email: drseyfikartal@gmail.com
-
Sub-Investigator:
- Esra Kongur, MD
-
Sub-Investigator:
- Zübeyir Sivrikaya, MD
-
Sub-Investigator:
- Gürdal Yılmaz, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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,
|
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
Other Names:
|
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
|
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
Other Names:
|
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
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).
|
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
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).
|
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
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).
|
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
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.
|
MSC treatment before (day 0) and after MSC application, on 3rd and 7th days,
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on mortality after MSC administration in Groups I, II, III
Time Frame: 7, 14 and 28 days after MSC application
|
The effect of MSC application at different times on mortality will be evaluated.
|
7, 14 and 28 days after MSC application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ahmet AKYOL, MD, Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences, Trabzon, Turkey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Anticipated)
February 28, 2022
Study Completion (Anticipated)
March 31, 2022
Study Registration Dates
First Submitted
January 27, 2022
First Submitted That Met QC Criteria
February 13, 2022
First Posted (Actual)
February 15, 2022
Study Record Updates
Last Update Posted (Actual)
February 15, 2022
Last Update Submitted That Met QC Criteria
February 13, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- Trabzon Kanuni TRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No personal data belonging to the participants were used.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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