NCT04261335已完成1 期
The Evaluation of Safety and Tolerability of CL2020 in Neonatal Hypoxic Ischemic Encephalopathy Patients With Therapeutic Hypothermia in the Dose Escalation Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.
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
- 4 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 36 weeks gestation, and either one of the following criteria (i.-iii.) i. Apgar score ≤5 at 10 minutes ii. Continued resuscitation for at least 10 minutes iii. pH <7.0 or base deficit ≥16 mmol/L in any blood sample obtained within 60 min of birth
- •Moderate or severe encephalopathy by a Sarnat criteria
- •Undergone therapeutic hypothermia started before six hours of birth, and done for 72 hours continuously
- •Birth weight ≥1,800 g
- •Heart rate ≥100/min, and SpO2 ≥90 %
- •Able to provide voluntary written consent after receiving adequate information about the study (consent will be obtained from an acceptable representative)
排除标准
- •Suspected or confirmed severe congenital abnormalities or chromosomal anomaly
- •Planned to undergo surgery or radiation therapy
- •Scheduled to take systemic corticosteroids treatment for over five days
- •Blood glucose ≥ 200 mg/dL
- •Participation in another clinical study (not exclude patients in observational studies)
- •Suspected or confirmed active and severe infection
- •Positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody or syphilis serum reaction
- •History of severe hypersensitivity or anaphylactic reaction
- •Severe complications
结局指标
主要结局
Incidence of adverse events
时间窗: until 12 weeks after the administration
Any adverse events are summarized.
次要结局
- Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators)(at 12, 26, 38, 52, and 78 weeks after administration)
- Mortality(all of the clinical trial period (up to 44 months))
- Presence of 1) head control, 2) roll over, 3) sitting position, 4) crawl, 5) independent gait, and 6) meaningful words(at 26, 38, 52, and 78weeks after administration)
- Presence of epilepsy(until 78 weeks after administration)
- Overall survival(all of the clinical trial period (up to 44 months))
- Duration of continuous respiratory support(up to 78 weeks)
- Presence of spasticity(at 12, 26, 38, 52, and 78 weeks after administration)
- Gross Motor Function Classification System (GMFCS) score(at 78 weeks after administration)
- The composite score of cognitive scale, language scale, motor scale, social-emotional scale, and adaptive behavior scale in Bayley Scales of Infant and Toddler Development Third edition(78 weeks after administration)
- Duration of continuous use of vasopressors or pulmonary vasodilators(up to 78 weeks)
- The developmental quotient in Kyoto Scale of Psychological Development 2001(78 weeks after administration)
- MRI score(at 2, and 78 weeks after administration)
研究者
Yoshiaki Sato
MD, PhD, Associate Professor at Department of Center for Maternal Neonatal Care, Nagoya University Hospital
Nagoya University
研究点 (2)
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