A ground-breaking clinical trial??underway at The University of Texas Health Science Center at Houston (UTHealth) is an innovative step in a growing number of studies exploring the potential of stem cell-based therapies to help initiate repair and induce healing of damaged brain tissue. The study is being performed in partnership with Children's Memorial Hermann Hospital, UTHealth's major children's teaching hospital.
The trial will involve children who have sustained traumatic brain injuries and who have access to their own umbilical cord blood stem cells, which were banked at birth. Children who meet the trial qualifications will travel to Children's Memorial Hermann Hospital to receive an IV infusion of their cord blood stem cells. They will then be followed at six months, one year and two years.
"The reason we have become interested in cord blood cells is because of the possibility of autologous therapy, meaning using your own cells. And the preclinical models have demonstrated some really fascinating neurological preservation effects to really support these Phase 1 trials," says Charles S. Cox, M.D., Children's Fund Distinguished Professor of Pediatric Surgery and Pediatrics at the UTHealth Medical School, director of the Pediatric Trauma Program at Children's Memorial Hermann Hosptial, and principle investigator of the trial. "There's anecdotal experience in other types of neurological injuries that reassures us in terms of the safety of the approach and there are some anecdotal hints at it being beneficial in certain types of brain injury."
The Phase I safety study will enroll 10 children ages 18 months to 17 years who have suffered moderate to severe traumatic brain injury (TBI) and are within 6 to 18 months of their injury.
A Closer Look at Brain Injuries
Brain injuries result from numerous causes including traumatic injuries from a physical force or non-traumatic injures such as a lack of blood supply to the brain. Most brain injuries fall into one of three categories:
?? Traumatic Brain Injury (TBI): occurs when a sudden trauma causes damage to the brain,
??????such as the head colliding with an object or an object piercing the skull and damaging the
??????brain tissue.(1)
?? Non-Traumatic or Acquired Brain Injury: is damage to the brain resulting from insults such
??????as a lack of oxygen, glucose or blood to the brain or exposure to a toxin. With a non-traumatic
??????injury, damage is usually spread throughout the brain, whereas TBI may be localized to one
??????area.(2)
- Perinatal Brain Injury: a non-traumatic brain injury sustained during the perinatal period which is typically defined as the five months prior to birth through one month after birth. These brain injuries may result from lack of oxygen or blood to the brain, perinatal stroke, infection, brain malformation, genetic disorders and many other conditions. Infants may develop permanent neurological impairment such cerebral palsy, epilepsy, learning disabilities or behavioral disorders.(3,4)
??Current Protocol for Brain Injury Cases
Today there is no therapy that can repair damage to the brain tissue. Current protocol focuses first on stabilizing the individual in order to minimize the damage and prevent further injury and second, on managing symptoms of the injury. Moderately to severely injured patients receive rehabilitation treatment tailored to the individual's neurological impairment in areas such as physical therapy, occupational therapy, speech/language therapy, psychology, psychiatry, and social support.(1)
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