TBI Clinical Trial - Stem Cells

Starting in January 2006, the The University of Texas Medical School at Houston and Memorial Hermann Children's Hospital are starting a clinical trial which will study the safety and potential of treating children suffering traumatic brain injury with stem cells derived from their own bone marrow.

The clinical trial will be the first ever to apply stem cells to treat traumatic brain injury. It is important to note that no embryonic stem cells will be involved.

This clinical trial is building upon laboratory and animal research that indicated 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. The clinical trial has the approval of the U.S. Food and Drug Administration (FDA).

Since it is a Phase I clinical trial, the first emphasis is the establishment of the procedures safety. A secondary goal is to observe possible therapeutic effects.

Ten head-injury patients from age 5 to 14 who meet criteria will enter the TBI clinical trial. Bone marrow will be extracted from the child's hip and processed to derive two types of progenitor stem cells: mesenchymal stem cells, which differentiate into bone, cartilage and fat cells (research indicates they 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.

All of this is to be accomplished within 48 hours of the injury. The patients will be monitored for possible side effects, and 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.

Since this type of safety trial does not involve enough patients there will be no broad conclusions about the effectiveness of treatment. They can, however, set the stage for larger-scale research.

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Clinical Trials Home

See also:

Memorial Hermann Foundation
Medical News Today
The University of Texas Health Science Center at Houston
National Institute of Child Health and Human Development
National Heart, Lung, and Blood Institute of the National Institutes of Health