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Clinical trial to test stem cell approach for children with brain injury

A unique clinical trial will gauge the safety and potential of treating children suffering traumatic brain injury with stem cells derived from their own bone marrow starting early next year at The University of Texas Medical School at Houston and Memorial Hermann Children's Hospital.

The clinical trial is the first to apply stem cells to treat traumatic brain injury. It does not involve embryonic stem cells.

"There is no reparative treatment for traumatic brain injury," said principal investigator Charles Cox, M.D., The Children's Fund, Inc. Distinguished Professor in Pediatric Surgery and Trauma at the medical school. "All we can do now is try to prevent secondary damage by relieving pressure on the brain caused by the initial injury."

Unlike bone, muscle and other organs, the brain does not repair itself effectively. Traumatic brain injury victims can regain some function through rehabilitation. Studies show between 15 and 25 percent of children suffering severe traumatic brain injury die, and survivors of even moderate injury often are devastated for life.

Approved by the U.S. Food and Drug Administration and the university's Committee for the Protection of Human Subjects (CPHS), the clinical trial builds on laboratory and animal research indicating that bone-marrow derived stem cells can migrate to an injured area of the brain, differentiate into new neurons and support cells, and induce brain repair.

"This would be an absolutely novel treatment, the first ever with potential to repair a traumatically damaged brain," said James Baumgartner, M.D., associate professor of pediatric neurosurgery and co-principal investigator on the project.

As a Phase I clinical trial, the project's first emphasis is to establish the safety of the procedure, with a secondary goal of observing possible therapeutic effects.

Cox and Baumgartner have permission to recruit 10 head injury patients to the study between th
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Source:University of Texas Health Science Center at Houston


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