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 ]

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.


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