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

e ages of 5 and 14 who meet criteria set for enrollment. After initial treatment and evaluation, a pediatric surgeon will approach the injured child's parents to explain the trial and request permission to enroll the child in the study.

If permission is granted, bone marrow will be extracted from the child's hip and then processed to derive two types of progenitor stem cells: mesenchymal stem cells, which differentiate into bone, cartilage and fat cells, and research indicates can also differentiate into neurons; and hematopoietic stem cells, which form all the cells needed for blood.

Preclinical research indicates that the mesenchymal stem cells play the major role in producing new neurons and support cells.

The Center for Cell and Gene Therapy at Baylor College of Medicine will process the bone marrow into the stem cell preparation and return it to Memorial Hermann Children's Hospital, where it will be given intravenously to the injured child.

All of this will be accomplished within 48 hours of the injury, Cox said. The children will be carefully monitored throughout for possible side effects. They will be evaluated for brain function one month and six months after the procedure to see if it is improved compared with historical data on the brain function of children of similar age who suffered a similar injury.

Safety trials involve too few patients to draw broad conclusions about the effectiveness of treatment. But they can set the stage for larger-scale research.

"All the preclinical data suggest this is a safe procedure with substantial information suggesting a possible treatment effect," Cox said.

Because the children are receiving their own cells, an immunological response to the treatment is unlikely.

Even marginal improvement could mean a great deal to someone who suffers a brain injury. "It could be the difference between being able to recognize your loved ones and not being able t
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Source:University of Texas Health Science Center at Houston


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