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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Yomra
      • Trabzon, Yomra, Turkey, 61500
        • Recruiting
        • Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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,
Drug: Mesenchymal Stem Cell Antigen-1, Human
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:
  • Human umblical cord deriveted Mesenchymal Stem Cell
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
Drug: Mesenchymal Stem Cell Antigen-1, Human
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:
  • Human umblical cord deriveted Mesenchymal Stem Cell
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.
Drug: Mesenchymal Stem Cell Antigen-1, Human
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:
  • Human umblical cord deriveted Mesenchymal Stem Cell

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trabzon Kanuni Education and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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