Safety and Feasibility of Allogeneic Cord Blood-Derived Cell Therapy in Preterm Infants with Severe Brain Injury (ALLO Trial)

Not Applicable

• Conditions: Severe Brain Injury; Severe Intraventricular Haemorrhage; Diffuse Cystic Periventricular Leucomalacia; Neurological - Other neurological disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12623001352695
• Lead Sponsor: Monash Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-21
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Preterm infants born before 28 completed weeks of gestation (up to 27+6 weeks, ALLO-1 trial) OR born between 28 and 36+6 weeks of gestation (ALLO-2 trial) AND
2. Severe brain injury detected on neonatal neuroimaging any time after birth. A severe brain injury will be considered as grade 3 (intraventricular haemorrhage with ventricular distension) or 4 (parenchymal haemorrhagic infarct) IVH and diffuse cystic (grade 3) periventricular leucomalacia.

Exclusion Criteria

1. Infants with known major congenital anomalies
2. Infants whose care is being redirected to comfort care.

Cell therapy will only be administered when preterm infants are clinically stable, which is deemed by the treating physician. Also, infants should not be receiving antimicrobial therapy for confirmed or presumed late-onset neonatal sepsis at the time of cell infusion as their course may be unpredictable and may confound adverse events falsely attributing to the cell therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified