Stem cells following haemorrhagic or ischaemic fetal stroke (STELLAR)

Phase 1

• Conditions: Fetal stroke; Stroke - Haemorrhagic; Stroke - Ischaemic; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12622000662763
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-05
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Infants with brain injury associated with fetal stroke after confirmation of brain injury on postnatal imaging (Cranial ultrasound, MRI brain) soon after birth. Whilst there is no gestational age cut off, it is expected most infants will be born at or near term gestation.

Exclusion Criteria

Infants who are likely to have redirection of care (palliation) for any reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of autologous cord blood collection and cell retrieval following antenatal diagnosis of fetal stroke, as proven by at least 20 mls of cord blood collected after cord clamping at birth (cord collection by research team)[At the end of cord blood collection and processing (first 48 hours)];Safety of umbilical cord blood derived cells (UCBC) administration as determined by absence of any adverse events (AE) necessitating cessation of cell infusion (e.g. anaphylaxis or major change in cardio-respiratory status), or any AE attributable to cell administration within first 48 hours of infusion (e.g. bacterial infection).<br>These will be assessed by close monitoring and collection of data on a case report from by research team.[48 hours post cell infusion(s)]

Secondary Outcome Measures

Name	Time	Method
eurodevelopmental assessments at 3-4 months (GMA, HINE)[3-4 months of (corrected) age];Neurodevelopmental assessments at 1 year (HINE, GMFM-66 scale)[1 year (corrected) age ];Neurodevelopmental assessments at 2 year (BSID-IV, hearing, vision, physical assessment). [2 years corrected age]