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.
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
1
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
Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences
Trabzon, Yomra, Turkey (Türkiye)
RECRUITINGChange 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).
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
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).
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
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).
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
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).
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
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.
Time frame: MSC treatment before (day 0) and after MSC application, on 3rd and 7th days,
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Effect on mortality after MSC administration in Groups I, II, III
The effect of MSC application at different times on mortality will be evaluated.
Time frame: 7, 14 and 28 days after MSC application