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Safety and Effectiveness of Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children
The purpose of this study is to test the safety and effectiveness of a cord blood infusion in children who have motor disability due to cerebral palsy (CP). The subjects will be children whose parents have saved their infant's cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion.
A Placebo-Controlled, Observer-Blinded, Crossover Study to Evaluate the Safety and Effectiveness of a Single, Autologous, Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children (Clinical Trial Identifier: NCT01072370)
STUDY DESIGN & DATES
Phase I & II, Randomized, Double-Blind
Study Start Date: Jan 2010
Estimated Study Completion Date: Feb 2014
Estimated Primary Completion Date: Feb 2013 (Final data collection date for primary outcome measure)
Kimberly R Gray, BBA, CCRP
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
ELIGIBILITY: INCLUSION CRITERIA
Must be more than 1 year of age and less than 12 years of age at the time of screening for inclusion in the study.
Clinical evidence of a non-progressive motor disability due to brain dysfunction. The subjects will not have the ability to sit independently by one year of age or the ability to walk by 18 months of age.
Have stored umbilical cord blood with CBR that meets all selection and testing criteria
Willing to comply with all study procedures
The nucleated cells available in the cord blood sample stored at CBR must exceed 1 X 107 cells per kg body weight. (Note: Because cord blood collection has been in process for about 16 years but widely for far less than that period, the age of most subjects likely will be considerably less than 12 years of age. Due to the amount due of cord blood available for most subjects, the body weight of subjects usually will not exceed 25 kg).
The patients must be seizure-free or seizures adequately controlled. If there is a suspicion of seizures and EEG should be done prior to inclusion.
ELIGIBILITY: EXCLUSION CRITERIA
Complicating medical issues that would interfere with blood drawing, such as venous access so limited that success is unlikely
Presence of obstructive hydrocephalus
Presence of progressive neurological disease
Presence of significant defect of brain development, such as schizencephaly or agenesis of corpus callosum
Presence of known chromosomal anomaly
Presence of major congenital anomaly
Severe intrauterine growth restriction (birth weight less than 1800 grams)
Cord blood viability <60%
Positive infectious disease markers from mother's blood or cord blood at the time of collection
Evidence of illness on planned infusion date (such as but not limited to fever >38.5, vomiting, diarrhea, wheezing, or crackles)
Use of immunosuppressive drugs
Evidence of known genetic disorder
Impaired hepatic or renal function