Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
研究概览
简要总结
The investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously.
The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes.
- •Over 18 years.
- •Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
- •Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
- •Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio <200 mm-Hg.
- •Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment.
- •Written or verbal informed consent from the patient, family member or legal representative.
排除标准
- •Any other cause of acute respiratory distress not attributable to SARS-Cov-
- •RT-PCR of SARS-Cov-2 negative.
- •Multi-organ failure (more than three organs)
- •Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason.
- •Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
- •Active tumor disease.
- •Previous immunosuppressive treatment.
- •Allergy or hypersensitivity to the administered products.
- •History of deep vein thrombosis or pulmonary embolism in the last 3 years.
- •Participation in other clinical trials during the 3 months prior to the initial visit.
研究组 & 干预措施
Treatment
Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
干预措施: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells (Drug)
结局指标
主要结局
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
时间窗: 6 months
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)
时间窗: 28 days
次要结局
未报告次要终点