A new clinical trial has just begun to study two different forms of stem cell therapies for children who have cerebral palsy (CP). This is a first-of-kind study and is being held at the University of Texas Health Science Center at Houston (UTHealth) Medical School. The purpose of this study is to compare the effectiveness and safety of banked cord blood to bone marrow stem cells. This will be a double-blinded, placebo-controlled study.
The study is led by Charles S. Cox, Jr., M.D., distinguished professor of Pediatric Surgery at UTHealth Medical School and director of the Pediatric Trauma Program at Children’s Memorial Hermann Hospital. The co-principal investigator is Sean I. Savitz, M.D., professor, and Frank M. Yatsu, M.D., chair in Neurology in the UTHealth Department of Neurology.
The current study makes use of Cox’s earlier research on stem cell therapy for children and adults who have been admitted to Children’s Memorial Hermann and Memorial Hermann-Texas Medical Center after they experienced a traumatic brain injury (TBI).
Thirty children between the ages of 2 and 10 who have cerebral palsy will be enrolled in the trial. Fifteen of these children have their own cord blood banked at Cord Blood Registry (CBR) and the other fifteen do not have banked cord blood. Five children in each group will be randomized to a placebo control group.
This trial requires that families must travel to Houston for therapy and follow-up visits at 6, 12 and 24 months. Parents will not be informed if their child has received placebo or stem cells until the 12-month follow-up exam. At that time, parents who children who didn’t receive stem cells have the option to have their children receive stem cell therapy with bone marrow or cord blood banked with CBR. The study has been approved by the FDA.
For more information on this cerebral palsy study at UTHealth, click the icon below to visit the visit the clinical trial.gov website: