Multicenter Phase I/IIa Study of Mesenchymal Stromal Cells for the Treatment of Patients with SARS-CoV-2 Pneumonia.
Overview
- Phase
- Phase 1
- Intervention
- Mesenchymal stem cell
- Conditions
- COVID-19 Pneumonia
- Sponsor
- Paulo Brofman
- Locations
- 1
- Primary Endpoint
- Safety of intravenously infused UCT-MSC suspension
- Status
- Withdrawn
- Last Updated
- last year
Overview
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 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.
Investigators
Paulo Brofman
Principal Investigator
Pontifícia Universidade Católica do Paraná
Eligibility Criteria
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;
Arms & Interventions
Treatment
Patient: Intravenous infusion of single-dose of Mesenchymal stem cells (MSCs)
Intervention: Mesenchymal stem cell
Placebo
Intravenous infusion of single-dose of Ringer's lactate, albumin and heparin solution
Intervention: Placebo
Outcomes
Primary Outcomes
Safety of intravenously infused UCT-MSC suspension
Time Frame: After first cell infusion until the end of study. The clinical follow-up of patients will be one year after the transplant.
The primary expected outcome is the safety and tolerability of using intravenously infused UTC-MSC suspension in patients with pneumonia caused by SARS-CoV-2. This outcome will be evaluated by recording adverse events that must be reported throughout the study period.
Secondary Outcomes
- Pulmonary function test to evaluate the improvement of respiratory function(Pre-infusion, on days 5 and 28, 3 and 6 months.)
- Radiography to evaluate the improvement of respiratory function(Pre-infusion, on days 5 and 28, 3 and 6 months.)
- 6-minute walk to evaluate the improvement of respiratory function(Pre-infusion, on days 5 and 28, 3 and 6 months.)
- Decrease on days of non-invasive mechanical ventilation(Six hours after infusion, days 1, 5 and 28, 3 and 6 months.)
- Biochemical tests to evaluate the improvement of laboratory parameters(Pre-infusion, on days 1, 5 and 28, 3 and 6 months.)
- Blood count to evaluate the improvement of laboratory parameters(Pre-infusion, on days 1, 5 and 28, 3 and 6 months.)
- Viral load to evaluate the improvement of laboratory parameters(Pre-infusion, on days 1, 5 and 28, 3 and 6 months.)
- Cytokine dosage to evaluate inflammatory parameters(Pre-infusion, on days 1, 5 and 28, 3 and 6 months.)
- Decrease in hospital stay(From admission to discharge, or a maximum of 6 months.)
- Computed tomography score to evaluate the improvement of pulmonary function(Pre-infusion, on days 5 and 28, 3 and 6 months.)
- Reduction in the percentage of intubated patients(After first cell infusion until six months after the transplant.)
- Decrease in mortality(After first cell infusion until the end of study. The clinical follow-up of patients will be six months after the transplant.)