A Phase I Dose Escalation Safety Trial of Repeated Mesenchymal Stem Cell Treatment for Neonatal Stroke

Sydney Children's Hospital Network0 个研究点目标入组 12 人开始时间: 2024年2月15日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•1.Term/near-term infant greater than or equal to 35 weeks’ gestation
•2.Diagnosis of a stroke within the first 21 days of life, characterized by predominantly unilateral ischemic lesion within the territory of the middle cerebral artery, as confirmed by MRI
•3.Infant available for treatment within 72 hours from stroke confirmation
•4.Informed consent obtained from the parent

•1.Born <35 weeks’ gestation;
•2.Stroke diagnosis made after 21 days of life;
•3.Any proven or suspected congenital anomaly; chromosomal disorder or metabolic disorder;
•4.Presence of an infection of the central nervous system;
•5.Requiring or likely to require Extracorporeal Membrane Oxygenation (ECMO; contraindicated for cell therapy) life support;
•6.Know positive test for HIV 1, HIV 2, hepatitis B virus, hepatitis C virus, or any other infection which in the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study;
•7.Venous thromboembolism currently receiving/requiring anti-coagulation;
•8.No realistic prospect of survival (e.g. severe brain injury), at the discretion of the attending physician.

发起方

Sydney Children's Hospital Network