NCT06427642招募中不适用
Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases
Shandong Qilu Stem Cells Engineering Co., Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions
研究概览
简要总结
Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.
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
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE.
- •For children with bronchopulmonary dysplasia (BPD): 1) preterm infants with definite gestational age of 25-30 weeks; 2) birth weight 401-1249 g; 3) the risk of BPD was assessed to be greater than 60%. The scoring was based on the BPD high risk scoring system established by the NCHD Neonatal Cooperative Network; 4)parents read the subject's instructions, agreed to the treatment and signed the informed consent.
- •For children with short bowel syndrome (SBS): 1) postoperative short bowel syndrome caused by neonatal necrotizing enterocolitis and other causes (developmental malformations of the digestive tract: intestinal atresia, anal atresia, intestinal stenosis, etc.); 2) parents read the subject's instructions, agreed to the treatment and signed the informed consent.
排除标准
- •For children with HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements.
- •For children with BPD: 1) with severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (posterior nostril atresia, tracheoesophageal fistula, cleft palate, etc.), complicated congenital heart disease, diaphragmatic hernia, shock, other serious comorbidities or complications (congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations and other diseases that affect lung development); 2) unable or unwilling to provide informed consent or unable to comply with trial requirements.
- •For children with SBS: unable or unwilling to provide informed consent or unable to comply with trial requirements.
结局指标
主要结局
Incidence of adverse reactions
时间窗: Within 12 hours after UCB-MNCs infusion
Monitor oxygen, heart rate, temperature, rash, infection, etc
次要结局
- Imaging test results(2 weeks and 6 months after UCB-MNCs infusion)
- Biomarker of HIE(7 days after UCB-MNCs infusion)
- Change of Gross Motor Function Measure (GMFM)(1, 3, 6 months after UCB-MNCs infusion)
- Biomarker of BPD(7 days after UCB-MNCs infusion)
- Incidence of complications(a year)
- Electroencephalography (EEG) results(7 days UCB-MNCs infusion)
- Ventilator supporting time(1 month after UCB-MNCs infusion)
- Change of Gross Motor Performance Measure (GMPM)(1, 3, 6 months after UCB-MNCs infusion)
- Inflammatory indicators concentrations(7 days after UCB-MNCs infusion)
研究者
研究点 (1)
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