When to Apply to Which Patient in MSC?

• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Drug: Mesenchymal Stem Cell Antigen-1, Human

• Registration Number: NCT05240430
• Lead Sponsor: Trabzon Kanuni Education and Research Hospital

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).

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-27
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-13
• Last Update Submitted: 2022-02-13
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-02-28
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stem cell application; Group I disease 0-7. days,	Mesenchymal Stem Cell Antigen-1, Human	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,
stem cell application; Group II; 8-14 days of the disease. days	Mesenchymal Stem Cell Antigen-1, Human	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
stem cell application; Group III; those applied on the 15th day and after.	Mesenchymal Stem Cell Antigen-1, Human	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.

Primary Outcome Measures

Name	Time	Method
Change in acute phase reactants (C-reactive protein (CRP) after MSC administration in group I, II, III	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Effect on mortality after MSC administration in Groups I, II, III	7, 14 and 28 days after MSC application	The effect of MSC application at different times on mortality will be evaluated.

Trial Locations

Locations (1)

Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences; 🇹🇷 Trabzon, Yomra, Turkey