Using a Baby’s Cord Blood to Repair its Brain
Wed, 05/28/2014 - 2:01pm
Lack of blood flow and oxygen delivery to a baby during labor and delivery can result in brain damage. This condition, referred to as hypoxic-ischemic encephalopathy (HIE), is treated by whole body cooling, which reduces the risk of complications by 25 to 35 percent. C. Michael Cotten, associate professor of pediatrics at Duke, is working with colleagues to develop an adjuvant therapy to further reduce the risk of complications for these fragile babies.
In a recent paper published in The Journal of Pediatrics, Cotten and his team report on the feasibility of using a baby’s own cord blood cells to aid the injured brain in repairing itself.
Through funding from a DTRI Pilot Award in 2009, Cotten received funding and assistance in navigating the regulatory process of obtaining an investigative new drug approval from the Food and Drug Administration. Starting in January 2009, the team enrolled 23 babies into a Phase I trial. The number of these newborns that died or had measurable neurologic problems at one year of age following the treatment of whole body cooling and cord blood cells was 41 percent. Babies who were cooled but did not receive cord blood cells had a 60 to 65 percent rate of death or survival with abnormal one year outcomes.
This feasibility study was small and was not a true randomized, blinded clinical trial. Cotten is now collaborating with other healthcare networks to develop a randomized trial aiming to enroll 250 to 400 newborns.
Cotten stresses the importance of a true collaboration at each site between the labor and delivery clinical staff, neonatologists, and blood cell laboratories, as well as neurodevelopmental specialists in order to be successful.
“This type of study takes commitment and enthusiasm from all areas and shows the true potential inter-disciplinary teams can contribute to research,” he said. “When you find this ideal collaboration, it speeds up the process of translating ideas from theories into proven, practical patient treatments.”
An abstract of the paper, “Feasibility of Autologous Cord Blood Cells for Infants with Hypoxic-Ischemic Encephalopathy” is available online.