Status:
WITHDRAWN
Mesenchymal Stromal Cells for the Treatment of Patients With COVID-19.
Lead Sponsor:
Paulo Brofman
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
COVID-19 Pneumonia
COVID-19
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed 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 la...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05433298
Start Date
May 1 2022
End Date
March 31 2023
Last Update
February 10 2025
Active Locations (1)
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1
Paulo Roberto Slud Brofman
Curitiba, Paraná, Brazil, 80215200