When to Apply to Which Patient in MSC?

Trabzon Kanuni Education and Research Hospital

Status: Unknown

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Treatments: Drug: Mesenchymal Stem Cell Antigen-1, Human

Study type: Observational

Funder types: Other

Identifiers

NCT05240430

Trabzon Kanuni TRH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1 estimated patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 3 patient groups

stem cell application; Group I disease 0-7. days,

Description:

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,

Treatment:

Drug: Mesenchymal Stem Cell Antigen-1, Human

stem cell application; Group II; 8-14 days of the disease. days

Description:

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

Treatment:

Drug: Mesenchymal Stem Cell Antigen-1, Human

stem cell application; Group III; those applied on the 15th day and after.

Description:

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.

Treatment:

Drug: Mesenchymal Stem Cell Antigen-1, Human