Safety and Efficacy Study of Human Embryonic Stem Cells Derived M Cells (CAStem) for the Treatment of Severe COVID-19 Associated With or Without Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Adverse reaction (AE) and severe adverse reaction (SAE)
研究概览
简要总结
A phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.
详细描述
CAStem is an injectable product composed of immunity- and matrix-regulatory cells (IMRCs), also named M cells, differentiated from clinical-grade human embryonic stem cells (hESCs) will be expanded, harvested, and formulated at a concentration of 50 x 10^6 cells/mL. CAStem will be cryopreserved and transported to clinical site using liquid nitrogen vapor shipping vessels (< -150ºC). Prior to injection, CAStem will be thawed to liquefy quickly, and then reconstituted in normal saline.In the present study, the intravenous infusion dose of CAStem will be 3, 5 or 10 million cells/kg.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adverse reaction (AE) and severe adverse reaction (SAE)
时间窗: Within 28 days after treatment
Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
Changes of lung imaging examinations
时间窗: Within 28 days after treatment
Evaluation by chest CT
次要结局
- Lymphocyte count (*10^9/L)(Within 28 days after treatment)
- Creatinine (umol/L)(Within 28 days after treatment)
- Creatine kinase (U/L)(Within 28 days after treatment)
- Duration of fever (Celsius)(Within 28 days after treatment)
- IL-2 (pg/mL)(Within 28 days after treatment)
- Rate of all-cause mortality within 28 days(Within 28 days after treatment)
- Time to SARS-CoV-2 RT-PCR negative(Within 28 days after treatment)
- Alanine aminotransferase (U/L)(Within 28 days after treatment)
- Lactate (mmol/L)(Within 28 days after treatment)
- IL-1beta (pg/mL)(Within 28 days after treatment)
- IL-8 (pg/mL)(Within 28 days after treatment)
- Changes of blood oxygen (%)(Within 28 days after treatment)
- C-reactive protein (mg/L)(Within 28 days after treatment)
- Procalcitonin (ng/L)(Within 28 days after treatment)
- IL-6 (pg/mL)(Within 28 days after treatment)
研究者
Qi Zhou
Director, Institute of Zoology, Chinese Academy of sciences
Chinese Academy of Sciences