An Open-label, dose-escalation, phase 1 clinical trial to determine the safety and dose of HIEstem, a treatment for neonatal intractable brain diseases

Medinno0 个研究点目标入组 12 人开始时间: 待定最近更新: 2022年9月20日

适应症

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 12

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 0(Day) 至 28(Day)（—）
性别: All

入选标准

•Hypoxic ischemic encephalopathy (HIE)
•1)Not less than 35 weeks of gestational age and not less than 1,800 grams of birth weight
•2)Begin of hypothermia treatment (systemic or selectively cerebral) within 6 hours after birth
•3)When investigational product can be administered within 7 days (168 hours) after completion of 72-hour hypothermia treatment
•4)Evidence of moderate to severe HIE
•Intraventricular hemorrhage (IVH)
•1)Within 14 days after diagnosis of IVH and within 28 days after birth
•2)Premature neonates of 23 or more and less than 34 weeks of gestational age
•3)Neonates diagnosed with intraventricular hemorrhage level 3 or 4 according to Papile’s severity classification criteria by brain ultrasound, as below

排除标准

•Hypoxic Ischemic Encephalopathy (HIE)
•1)Less than 36 weeks of gestation age or less than 1,800 grams of birth weight
•2)Hypothermia treatment began 6 hours after birth
•3)History of or suspicious prenatal cerebral hemorrhage or intracranial infection (meningitis and encephalitis caused by bacteria, viruses, tuberculosis, parasites, etc.)
•4)Genetic or congenital abnormalities that affect neurodevelopment or require various surgical treatments, i.e., severe congenital brain malformations (hydrocephalus, encephalocele, etc.), cyanotic or non-cyanotic congenital heart defects that cause heart failure, chromosomal abnormalities (Edward syndrome, Patau syndrome, Down syndrome, etc.) and severe congenital malformations (hydrops fetalis, pulmonary hypoplasia, congenital diaphragmatic hernia, congenital pulmonary cyst disease, etc.)
•5)Severe congenital infectious diseases (herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
•6)Microcephaly with head circumference less than 30 cm
•7)CRP > 10 mg/dl, active infection that does not respond to appropriate antibiotics, or clinically significant fulminant sepsis
•8)Platelet count < 50,000/uL that is not expected to be corrected by the time of administration
•9)Severe bleeding tendency that is not expected to be corrected by the time of administration
•10)Expected surgery or death within 72 hours before or after administration of investigational product
•11)Clinical investigators’ judgment indicating unsuitability due to parents, legal representative, or other reasons.
•Intraventricular hemorrhage (IVH)
•1)Suspected intraventricular hemorrhage before birth
•2)History of or suspicious prenatal cerebral hemorrhage or intracranial infection (meningitis and encephalitis caused by bacteria, viruses, tuberculosis, parasites, etc.)
•3)Disorders listed below, at the time of screening,
•?Serious congenital brain malformations (hydrocephalus, encephalopathy, etc.)
•?Cyanotic or non-cyanotic congenital heart defects that cause heart failure (patency of ductus arteriosus is excepted), chromosomal abnormalities (Edward syndrome, Patau syndrome, Down syndrome, etc.), and severe congenital malformations (hydrops fetalis, pulmonary hypoplasia, congenital diaphragmatic hernia, congenital pulmonary cyst disease, etc.)
•?Severe congenital infectious disease (herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
•?CRP > 10 mg/dl, active infection that does not respond to appropriate antibiotics, or clinically significant fulminant sepsis
•4)Platelet count < 50,000/uL that is not expected to be corrected by the time of administration
•5)Recurrent metabolic acidosis (pH < 7.1, BE < -20) that is not expected to be corrected by the time of administration of investigational product
•6)Expected surgery within 72 hours after administration of investigational product or expected surgery or death within several days after administration of investigational product
•7)Patients with a history of participating in other clinical trials
•8)Neonates evaluated as unsuitable to participate by clinical investigators

研究者

发起方

Medinno

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