Clinical Trial: Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Neonatal Encephalopathy Consortium, Japan
Current Primary Outcome: Changes in serum levels of cytokines and trophic factors [ Time Frame: From birth up to 10 days of age ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Association with neuroimaging and neurodevelopmental functional outcome [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: Neonatal Encephalopathy Consortium, Japan
Dates:
Date Received: May 26, 2015
Date Started: April 2015
Date Completion: February 2018
Last Updated: May 26, 2015
Last Verified: May 2015