By National Institute of Neurological Disorders and Stroke
Approximately 50,000 infants per year (961 per week) are born at less than 28 weeks of gestation in the US. Cerebral palsy, deafness, blindness, and/or mental retardation are present in up to 50% of surviving extremely preterm infants at school age. Perinatal care costs for these infants exceed US$18 billion every year. The burden of extreme prematurity to each patient and to society is further magnified by the years of productive life lost. New therapies are needed to improve these outcomes.
Recombinant human erythropoietin (Epo) is a promising novel neuroprotective agent. Epo decreases neuronal programmed cell death resulting from brain injury; it has anti-inflammatory effects, increases neurogenesis, and protects oligodendrocytes from injury.
We hypothesize that neonatal Epo treatment of ELGANs will decrease the combined outcome of death or severe NDI from 40% to 30% (primary outcome), or the combined outcome of death plus moderate or severe NDI from 60% to 40% (secondary outcome) measured at 24-26 months corrected age.
Nearly 5000 samples of umbilical cord blood have been stored in Royan Institute’s public bank and 60,000 samples in its private bank, said Morteza Zarrabi, director general of the institute.
“This year (started March 21), we were successful in using umbilical cord blood for the treatment of patients diagnosed with cerebral palsy,” IRNA quoted him as saying.
Until now, seven samples in public banks and six samples in private banks have been successfully used in transplant surgeries, he said, adding that “one of the cases involved treatment of a cancer patient who is in good health now.”
Samples stored in public banks have been donated by families and can be used for all patients with specific diseases and disabilities. In private banks samples are stored just for the donor family and therefore a fee is charged. The cost of collection and genetic testing of each sample is about $645 and the annual charge for storage is $33.
Stroke occurs when blood flow is interrupted to part of the brain, leading to the destruction of brain cells. The risk of a stroke in children is greatest in the first year of life, and peaks during the perinatal period, roughly the weeks before and immediately after birth. Now, families who have saved their children’s cord blood with Cord Blood Registry® have access to a new use for the stem cells. A new clinical trial at the Florida Hospital for Children will investigate using a child’s own cord blood stem cells as treatment after a pediatric stroke.
Recruitment is underway to enroll 10 children between the ages of 6 weeks and 6 years who have experienced a stroke in utero or immediately after birth, and who have a CBR-processed cord blood unit which was collected at birth. Subjects will first receive a baseline neurologic evaluation which includes brain imaging, evaluation of epilepsy, nerve impulses, and bladder control issues, which will help assess the overall severity of the stroke’s impact prior to treatment. After this evaluation is complete, eligible patients will receive a single autologous stem cell infusion, with follow-up testing to occur after six and 12 months.