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

Paulo Brofman

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

COVID-19

COVID-19 Pneumonia

Treatments

Biological: Mesenchymal stem cell

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05433298

MSC SARS-CoV-2

U1111-1267-1200 (Other Identifier)

31935420.7.1001.0020 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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.