Safety and feasibility of regenerative therapy using autologous cord blood cells in neonates with hypoxic ischemic encephalopathy

Background:
A major cause of cerebral palsy is considered to be a hypoxic ischemic encephalopathy in newborn infants with moderate or severe asphyxia. To date, therapeutic hypothermia has been the only effective treatment for hypoxic ischemic encephalopathy to prevent the development of cerebral palsy. However, even if infants are treated with therapeutic hypothermia, nearly half of them die or left with moderate to severe neurological impairments as yet. A recent regenerative medicine indicated benefits of autologous umbilical cord blood stem cell transplantation combined with therapeutic hypothermia for hypoxic ischemic encephalopathy (Cotten et al. JP 2014). Umbilical cord blood stem cells which combines the action of suppressing early inflammation and the action of promoting regeneration is expected as a remarkable excellent therapeutic method as a treatment for hypoxic ischemic encephalopathy.
Methods:
Umbilical cord blood stem cells was collected aseptically and prepared by using SEPAX which need more than 40ml of umbilical cord blood. Infants admitted to the NICU of 6 hospitals in our research group will be eligible if they are ≥36 weeks’ gestational age and birth weight ≥1800 g with hypoxic ischemic encephalopathy and meet the cooling criteria.
Results:
Autologous umbilical cord blood stem cells therapy for neonatal hypoxic ischemic encephalopathy in addition to therapeutic hypothermia was performed in 6 newborn patients. All of them have discharged NICU without support of ventilator and survived from 18 months to 4 years.
Conclusions:
Autologous umbilical cord blood stem cells for newborn hypoxic ischemic encephalopathy is safe and feasible, and warrants a larger and controlled phase II study.