Mesenchymal Stromal Cells for the Treatment of Patients With COVID-19.

Multicenter Phase I/IIa Study of Mesenchymal Stromal Cells for the Treatment of Patients With SARS-CoV-2 Pneumonia.

The purpose of this study is evaluate the feasibility, safety and potential efficacy of an advanced cell therapy product for the treatment of patients with SARS-CoV-2 pneumonia.

Forty patients with COVID-19 will receive an intravenous infusion of one dose of 1.000.000 umbilical cord mesenchymal cells per kilo of the patient. Twenty patients will receive a placebo (Ringer's lactate solution, albumin and heparin). Conventional treatment will be performed together with the infusion of cells, during the study period. The evaluation times will be at pre-infusion, 6 and 24 hours, days 5 and 28, 3 and 6 months. The patient exams performed: serology, biochemistry, blood count and blood gas analysis, metabolomics/proteomics, antibody evaluation, electrocardiogram, CT-scan and X-ray, cytokines, viral load, cytometry, and clinical evaluation. The patients will be evaluated all the time, during hospitalization period, to assess adverse events.

Inclusion Criteria:

• Both sexes;
• aged 18 to 79 years old;
• hospitalized patients;
• radiological diagnosis of viral pneumonia;
• virological diagnosis of SARS-CoV-2 infection;
• with noninvasive ventilatory support;
• C-reactive protein and ferritin above the reference value considered normal;
• assent confirmed to participate in the study.

Exclusion Criteria:

• Contraindications for use of corticosteroids;
• immunosuppressive, cytotoxic and antiviral treatment, experimental medications and chronic corticosteroid use;
• morbid obesity (BMI> 35);
• multiple organ dysfunction syndrome;
• pre-malignant neoplastic conditions with life expectancy lower than 1 year old;
• pre-existing chronic illnesses like chronic dialysis kidney disease, chronic liver disease, congestive heart failure Class IV; pulmonary hypertension (WHO Class III/IV);
• pre-existing or current thromboembolic pathology;
• transplanted patients;
• pre-existing severe allergic reaction;
• history of HIV and tuberculosis;
• enrollment in another clinical trial;
• pregnancy or breastfeeding.