FDA Approves Clinical Study Involving Stem Cells for Cerebral Palsy in Children
Cerebral palsy is a serious condition affecting up to 3 children in 1,000. It is caused by a injury of the brain or inadequate oxygenation of the brain before, during or after birth in the first years of life. The condition can affect movement, cognitive skills, vision and hearing. At the time of writing there is no cure for cerebral palsy but the FDA has approved the first clinical study to determine the potential benefits of stem cells for children with cerebral palsy.
The study will be conducted by at Medical College of Georgia and will research the potential benefits of stem cell therapy for children will cerebral palsy. 40 children from 2 to 12 years will participate in the trial after being neurologically examined. Children that can participate in the study must meet the following conditions: inability to sit without assistance by 12 months of age or inability to walk by 18 months of age, not having seizures or having seizures that can be controlled. One half of the participants will receive a stem cell infusion from their own cord blood, while the other 20 children will receive a placebo. Both groups will be examined by physicians not knowing which children received stem cell infusion and placebo after three months. Then the children that received a placebo will be given the infusion. All will be re-examined after three and six months later.
The purpose of the study is not use of stem cells as a potential cure for cerebral palsy but the evaluation of the potential benefits of stem cell therapy for children who have cerebral palsy. The results of the animal studies are encouraging as well as the therapy involving core blood that has been used for two decades. However, the research that will be conducted at Medical College of Georgia is going to be the first controlled clinical study involving stem cells.
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