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

Abstract

This trial aims to assess the safety and feasibility of using allogeneic UCBCs in preterm infants with severe brain injury. The primary objectives include evaluating the availability of at least 4/6 HLA-matched allogeneic UCBCs for more than 60% of eligible infants and assessing the safety of UCBCs administration by monitoring adverse events and the absence of graft versus host disease (GVHD).

Secondary objectives involve evaluating the impact of UCBC administration on short and long-term clinical outcomes, such as death, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, sepsis, developmental delay, cerebral palsy, blindness, and deafness. Additionally, the trial aims to assess the effect of UCBCs on immune responses by measuring cytokine levels.

The study will enroll 20 preterm infants with severe brain injury, divided into two strata based on gestational age. The infants will receive one intravenous infusion of 4/6 or higher HLA-matched allogeneic UCBCs obtained from the BMDI Cord Blood Bank at a dose of 50 million cells per kg. The trial will span 3-5 years, including a 24-month post-intervention follow-up period. The recruitment will be limited to Monash Children's Hospital.