A procedure involving stem cells taken from patients’ own bone marrow to treat traumatic brain injury in children is safe, according to the results of a Phase 1 clinical trial.
The trial included 10 children aged 5-14 with severe traumatic brain injuries. Within 48 hours of their injuries, the children received stem cells processed from their own bone marrow.
Six months following the procedures, the children are showing no signs of further damage caused by the use of the stem cells. Though this study only points out that the procedure is safe so far, all of the children from the study had significant improvements.
Stem cell research studies such as this one are producing more and more evidence that stem cell treatments can be safe and effective.
With very few effective treatments for brain injury patients, these studies provide great promise for the future of medicine.
The University of Texas Health Science Center at Houston press release below offers more details about this and other stem cell studies.
UTHealth study: Stem cells may provide treatment for brain injuries
Preliminary results show safety of bone marrow stem cells in traumatic brain injury
Stem cells derived from a patient’s own bone marrow were safely used in pediatric patients with traumatic brain injury (TBI), according to results of a Phase I clinical trial at The University of Texas Health Science Center at Houston (UTHealth). The results were published in this month’s issue of Neurosurgery, the journal of the Congress of Neurological Surgeons.
“Our data demonstrate that the acute harvest of bone marrow and infusion of bone marrow mononuclear cells to acutely treat severe TBI in children is safe,” said Charles S. Cox, Jr., M.D., the study’s lead author and professor of pediatric neurosurgery at the UTHealth Medical School. The clinical trial, which included 10 children aged 5 to 14 with severe TBI, was done in partnership with Children’s Memorial Hermann Hospital, where Cox is director of the pediatric trauma program.
All the children were treated within 48 hours of their injury with their own stem cells, which were collected from their bone marrow, processed and returned to them intravenously. UTHealth’s Department of Neurology is also currently testing the same bone marrow stem cell procedure in adults with acute stroke. In a separate trial, Cox is testing the safety of using a patient’s own cord blood stem cells for traumatic brain injury in children.
As a Phase I trial designed to look at feasibility and safety, the study did not assess efficacy. However, after six months of follow-up, all of the children had significant improvement and seven of the 10 children had a “good outcome,” meaning no or only mild disability.
Children who survive severe TBI are often left with serious complications and disability. Currently, there are no effective treatments to protect or promote repair of the brain in these brain-injured children.
Other UTHealth co-authors of the study include Linda Ewing-Cobbs, Ph.D., professor, Department of Pediatrics; Khader M. Hasan, Ph.D., associate professor, Department of Diagnostic and Interventional Imaging; Mary-Clare Day, R.N., senior research nurse; Fernando Jimenez, M.S., senior research assistant, Department of Pediatric Neurosurgery; Peter A. Walker, M.D., and Shinil K. Shah, M.D., residents, Department of Surgery; and James Baumgartner, M.D., research collaborator, Department of Pediatric Surgery.