NCT04522817撤回1 期
CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.
详细描述
This open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous CD34+ cells for the repair of COVID-19 induced pulmonary damage in adults. Eligible subjects will receive a single administration of CLBS119.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Initial diagnosis with COVID-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate SARS CoV-2 RT-PCR test
- •Receiving or received ventilatory support for COVID-19 pneumonia/ARDS
- •Evidence for ongoing pulmonary involvement based on P/F ratio <300
- •Able to provide informed consent
排除标准
- •Immunocompromised or current use of immunosuppressive agents other than corticosteroids
- •History of autoimmune disease
- •Evidence of multiorgan failure
- •Subject is pregnant or lactating at the time of signing the consent
- •Participation in any other clinical trial of an experimental treatment for COVID-19
- •History of sickle cell disease
研究组 & 干预措施
CLBS119 Active Treatment
Experimental
Single administration of CLBS119
干预措施: CLBS119 (Biological)
结局指标
主要结局
Adverse events
时间窗: Through end of study (6 months)
次要结局
- Change in oxygen saturation(Change from baseline)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for RetinopathyNon-exudative Age-related Macular DegenerationRetina Vein OcclusionRetinitis PigmentosaHereditary Macular DegenerationDiabetic RetinopathyNCT01736059University of California, Davis15
Unknown
1 期
An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.AIDSHIV InfectionsNCT03517631Shanghai Public Health Clinical Center6
终止
2 期
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular DysfunctionCoronary Microvascular DysfunctionCoronary Microvascular DiseaseMicrovascular Coronary Artery DiseaseNCT04614467Lisata Therapeutics, Inc.34
已完成
2 期
Efficacy Study of CD34 Stem Cell in Chronic Stroke PatientsStrokeMiddle Cerebral Artery InfarctionNCT00950521China Medical University Hospital30
终止
1 期
A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSFDiabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSFNCT00765050PETHEMA Foundation13