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What? Clinical trial evaluating the effects of a cord blood infusion in children with cerebral palsy.
Where? Participants receive care at the Medical College of Georgia.
Why? To evaluate the safety and effectiveness of infusing a child's own (autologous) cord blood in children in children with cerebral palsy.
How? One unit of cord blood that has been treated to remove red blood cells and enriched with mononuclear cells (a type of immune cell) is infused into the child using an IV.
When? This 1year study is currently accepting patients. Patients will be required to travel to the Medical College of Georgia in Augusta, GA for the procedure and for follow-up evaluation over the treatment period.
Who may participate? Patients must meet the following criteria:
- Children 2 to 12 years old
- 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 a Cord Blood Registry that meets all selection and testing criteria
- Willing to comply with all study procedures
- Child must be seizure free or has seizures adequately controlled. If there is a suspicion of seizures an EEG should be done prior to inclusion
- The cord blood sample has to have more than 20 million nucleated cells (immune cells) for each kilogram of the child's body weight
- Child who has a medical issue that would interfere with drawing blood
- Child with obstructive hydrocephalus
- Child with a progressive neurological disease
- Child with a significant defect in the development of the brain, such as schinzencephaly or agenesis, or corpus callosum
- Child that has a known chromosomal anomaly
- Child has a major congenital anomaly
- Child has 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 ⁰C, vomiting, diarrhea, wheezing, or crackles
- Use of immunosuppressive drugs
- Evidence of know genetic disorder
- Impaired hepatic or renal function
Dr. James E. Carroll
Medical College of Georgia
Department of Neurology
1120 Fifteenth Street
Augusta, Georgia 30912