Cord blood therapy in premature babies: a safety and feasibility study

Abstract

Preterm brain injury continues to be an important complication of preterm birth, especially in extremely premature and extremely low birth weight infants. Umbilical cord blood derived stem cells (UCBCs) are being increasingly evaluated for their neuroprotective and neuroreparative properties. There remains a paucity of information on the feasibility and safety of autologous UCBC transplantation in extremely premature infants.

Methods: A single centre safety and feasibility study in preterm babies born before 28 weeks gestation. Cord blood will be collected after birth and, if sufficient blood is obtained, UCBC will be harvested from the cord blood, characterised and stored. After excluding infants who have already suffered severe preterm brain injury, preterm infants will be infused with autologous UCBC via the intravenous route at a dose of between 25-50 million UCBCs/kg body weight. A minimum of 20 infants will be administered autologous UCBCs. Primary outcomes will include feasibility and safety. Feasibility will be determined by access to sufficient cord blood at collection and UCBCs following processing. Safety will be determined by lack of adverse events directly related to autologous UCBC administration in the first few days after administration. Secondary outcomes studied will include neonatal, and neurodevelopmental morbidities till 2 years of life.