This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.
This is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. Infants will be followed for safety and neurodevelopmental outcome up to 18 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Saitama Medical University
Kawagoe, Saitama, Japan
Yodogawa Christian Hospital
Osaka, Japan
Adverse event rates
Adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) will be compared between the cell recipients and historical controls at 30 days of age.
Time frame: first 30 postnatal days
Efficacy
Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be compared between the cell recipients and historical controls.
Time frame: 18 months
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Osaka City General Hospital
Osaka, Japan
Osaka City University
Osaka, Japan