Clinical trial NCT05240430: When to Apply to Which Patient in MSC?
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?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: COVID-19
SARS-CoV-2
Mesenchymal Stem Cell
Intensive Care Units
Lead sponsor: Trabzon Kanuni Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
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

Brief 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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in acute phase reactants (C-reactive protein (CRP) after MSC administration in group I, II, III
timeFrame: 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
measure: Change in acute phase reactants (procalcitonin) after MSC administration in group I, II, III
timeFrame: 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
measure: Change in acute phase reactants ( white blood cell count) after MSC administration in group I, II, III
timeFrame: 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
measure: Changes in respiratory support after MSC administration in Groups I, II, III
timeFrame: 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
measure: Changes in arterial blood gas analysis (partial oxygen/fractionated oxygen (Pa/Fi) ratio) after MSC administration in Groups I, II, III
timeFrame: MSC treatment before (day 0) and after MSC application, on 3rd and 7th days,
Secondary outcomes:
measure: Effect on mortality after MSC administration in Groups I, II, III
timeFrame: 7, 14 and 28 days after MSC application
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences
state: Yomra
Study officials:
affiliation: Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences, Trabzon, Turkey
name: Ahmet AKYOL, MD
role: STUDY_CHAIR
References: