Cerebral Palsy Clinical Trials

Cerebral palsy, caused by a brain injury or lack of oxygen in the brain before birth or during the first few years of life, can impair movement, learning, hearing, vision, and cognitive skills. According to the Centers for Disease Control and Prevention, it is estimated that roughly 1 in every 323 children in the United States has been diagnosed with cerebral palsy.

Georgia Regents University

Researchers at Georgia Regents University, in partnership with Cord Blood Registry, are conducting a landmark FDA-regulated clinical trial to evaluate the use of a cord blood stem cell infusion for the treatment of cerebral palsy in children.

Dr. James Carroll, the principal investigator of the study, notes that "autologous stem cell transplantation, in which the transplant recipient is also the donor, is the safest form of stem cell transplantation because it carries virtually no threat of immune system rejection.”

How does the study work?

Recruiting efforts are underway to enroll 40 children, between the ages of 1 and 12, diagnosed with cerebral palsy. Any level of cerebral palsy severity will be allowed. The subjects will be children whose parents have saved their infant’s cord blood, who have clinical evidence of a non-progressive motor disability, and whose parents intend to have a cord blood infusion.

To ensure consistency in cord blood stem cell quality, CBR is the only family stem cell bank providing units from clients for the study. Study participants must have been unable to sit independently by 12 months or unable to walk by 18 months and must be seizure-free or have seizures that are adequately controlled.

University of Texas Health Science Center at Houston

Researchers at The University of Texas Health Science Center at Houston, in collaboration with Cord Blood Registry, are commencing an innovative FDA-regulated clinical trial to investigate two forms of stem cell therapy in children diagnosed with cerebral palsy. The study aims to compare the safety and efficacy of an intravenous infusion of banked cord blood stem cells to freshly harvested bone marrow stem cells.

Dr. Charles Cox, the principal investigator of the study, notes that "there is preclinical data indicating that the ongoing neuroinflammatory response is a driver of further injury in CP so the hope is to reduce this neuroinflammation." "Our goal is to break the cycle of inflammation and injury," adds Cox.

How does the study work?

Recruiting efforts are underway to enroll 30 children, between the ages of 2 and 10, diagnosed with cerebral palsy: 15 with a CBR processed and stored cord blood unit who may be administered an autologous stem cell infusion and 15 children who may undergo a bone marrow harvest and autologous stem cell infusion. To evaluate improvement in functional status among participants, five children in each group will be randomized to a placebo control group during the baseline/treatment visit.

Parents will not be informed if their child received stem cells or were given a placebo until the 1-year follow-up examination. At that time, parents whose children were administered the placebo may elect to have their child receive the stem cell treatment, either through bone marrow harvest or cord blood. In order to be eligible to participate in the cord blood arm of the trial, families must have a qualified CBR processed unit that was collected at birth.

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