Umbilical cord blood mononuclear cells for hypoxic neurologic injury in infants with congenital diaphragmatic hernia (CDH)
Congenital diaphragmatic hernia (CDH) affects 1 in 2500 children born in the US, with severe CDH (>50% of all live born infants with CDH) carrying a death rate greater than 50% along with an increased chance of neurodevelopmental delay (brain injury). There is no current treatment that can preserve brain function in these children who have otherwise normal brain function. Emerging evidence indicates that cells from the umbilical cord, functioning to reduce inflammation and improve function, have multiple mechanisms of action in various diseases. The purpose of this study is to investigate the use of autologous (your own) umbilical cord blood (UCB) mononuclear cells to improve brain function among infants with high-risk CDH. The primary objectives of this study are to determine if the treatment is safe for infants with CDH, and to examine if autologous UCB cellular therapy improves neurological/neurodevelopmental outcomes. For questions about this study, please contact the Principal Investigator, Matthew Harting, MD, at email@example.com or at 713-500-7300. Additional information about this study can be found on the clinicaltrials.gov website at https://clinicaltrials.gov/ct2/show/NCT03526588.