The University of Texas Health Science Center at Houston (UTHealth) has begun enrollment for the first Phase I safety study approved by the U.S. Food and Drug Administration to investigate the use of a child’s own umbilical cord blood stem cells for traumatic brain injury in children.
The study is being performed in conjunction with Children’s Memorial Hermann Hospital, UTHealth’s primary children’s teaching hospital.
The study is led by principal investigator Charles S. Cox, a professor of pediatric surgery and pediatrics at the University of Texas Medical School at Houston.
It will enroll 10 children ages 18 months to 17 years who have umbilical cord blood banked with Cord Blood Registry (CBR) and have suffered moderate to severe traumatic brain injury (TBI).
The study is not designed for acute care and will only enroll participants within 6-18 months of their injury.
Although the neurologic outcome for nearly all types of brain injury (with the exception of abuse) is better for children than adults, trauma is the leading cause of death in children, and the majority of the deaths are attributed to head injury.
“Using cord blood is a critical link in the next step of UTHealth’s programmatic approach to researching stem cell therapies for brain injury,” Cox said. “Implementing this novel therapy has required strong partnerships with Children’s Memorial Hermann Hospital and the CBR Center for Regenerative Medicine, and is possible through a critical infrastructure investment by the state of Texas and private philanthropy.”
A recently completed Phase I study at UTHealth (publication in press), which investigated a bone-marrow stem cell therapy in children with acute traumatic brain injury, revealed positive safety results, Cox said.
The FDA-authorized protocol is specific to the standardized processing and storage protocol of CBR, making it the only family stem cell bank providing patients for the study.
UTHealth is also investigating stem cell therapy for acute stroke patients in an NIH-sponsored, Phase I study by Sean Savitz, M.D., associate professor in the Department of Neurology; and for acute myocardial infarction (heart attack) patients in a Phase II study led by Ali E. Denktas, M.D., assistant professor in the Department of Internal Medicine.
Contact: To enroll in the study, parents or caregivers of patients who have suffered a traumatic brain injury should contact CBR (http://www.cordblood.com/UTHealth) and after consent is obtained, the information will be relayed to the UTHealth research group. If all qualifications are met, the patient will travel to Children’s Memorial Hermann Hospital. The cells will be processed and intravenously infused. Patients will be followed at six months, one year and two years.