Multicenter Phase I/IIa Study of Mesenchymal Stromal Cells for the Treatment of Patients with SARS-CoV-2 Pneumonia.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Safety of intravenously infused UCT-MSC suspension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment
Patient: Intravenous infusion of single-dose of Mesenchymal stem cells (MSCs)
干预措施: Mesenchymal stem cell (Biological)
Placebo
Intravenous infusion of single-dose of Ringer's lactate, albumin and heparin solution
干预措施: Placebo (Other)
结局指标
主要结局
Safety of intravenously infused UCT-MSC suspension
时间窗: 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.
次要结局
- 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.)
研究者
Paulo Brofman
Principal Investigator
Pontifícia Universidade Católica do Paraná