This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.
The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.
Study Type
OBSERVATIONAL
Enrollment
18
The neonates receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12-24, 36-48, and 60-72 hours after the birth.
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Yodogawa Christian Hospital
Osaka, Japan
Changes in serum levels of cytokines and trophic factors
Time frame: From birth up to 10 days of age
Association with neuroimaging and neurodevelopmental functional outcome
Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be assessed whether they are associated with serum levels of cytokines and trophic factors during the early neonatal period.
Time frame: 18 months
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Osaka City General Hospital
Osaka, Japan
Osaka City University Hospital
Osaka, Japan