EOSTeM (NEOnatal STroke Mesenchymal Stem Cell) Trial: Assessing the Safety of Mesenchymal Stem Cells for Babies with Stroke

Phase 1

Withdrawn

Conditions: Term/near term neonatal stroke
Neurological - Other neurological disorders
Stroke - Ischaemic
Reproductive Health and Childbirth - Complications of newborn

Registration Number: ACTRN12624000145505

Lead Sponsor: Sydney Children's Hospital Network

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: All

Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the immediate safety of MSCs for neonatal stroke assessed via the occurrence of AEs and SAEs. All safety events will be captured, with some prespecified and graded based on severity. These include infusion reactions, infection, local site reactions and changes to vital signs and respiratory support. Data are collected from medical records and continuous physiological monitoring within neonatal intensive care. [ During each infusion and up to 48 hours after the last infusion. Formal reporting of vitals will be taken immediately prior to the infusion, every 5 minutes during the infusion, 15 minutes after the infusion and then every 4 hourly or as clinically indicated. ]

Secondary Outcome Measures