Clinical Trial Using Stem Cells

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

This clinical trial is the first to apply stem cells to treat traumatic brain injury. No embryonic stem cells will be involved.

The clinical trial will build upon 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. The clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and the university's Committee for the Protection of Human Subjects (CPHS).

A Phase I clinical trial, the first emphasis will be to establish the safety of the procedure, with a secondary goal of observing possible therapeutic effects.

Ten head-injury patients from age 5 to 14 who meet criteria will be set for enrollment. After an initial treatment and evaluation, a pediatric surgeon will explain the trial to the child's parents and seek their permission to enroll the child in the study.

Once 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 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.

These types of safety trials do not involve enough patients to make broad conclusions about the effectiveness of treatment. However, they can set the stage for larger-scale research.

The project is funded by the Memorial Hermann Foundation, internal research funds from The Office of the President at The University of Texas Health Science Center at Houston, and the National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute of the National Institutes of Health.

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