Clinical Trial: Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Safety and Efficacy Study of Neural Progenitor Cell Transplantation and Paracrine Factors From Human Mesenchymal Stem Cells to Treat Newborn With Hypoxic-ischemic Encephalopathy<

Brief Summary: The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy

Detailed Summary: Neonates diagnosed moderate/severe Hypoxic-Ischemic Encephalopathy after birth will receive routine therapy and be randomized to four arms for allogenic neural progenitor cells transplantation，paracrine factors of human mesenchymal stem cells intrathecal injection，combination of cell and factor or only routine therapy. Patients will be followed for neurodevelopmental outcome at 12 and 18 months in Pediatrics of Navy General Hospital. Magnetic Resonance Imaging, electroencephalogram, Bailey scores, Peabody development measure scale and Gross motor function measure assessment will be obtained in the following research.Results will be analyzed and described in study reports.
Sponsor: Navy General Hospital, Beijing

Current Primary Outcome:

  • Neonatal Behavioral Neurological Assessment [ Time Frame: 14days after birth ]
  • number of adverse events [ Time Frame: 7days after cell or factor injection ]
    adverse events like fever、infection、seizures、hemorrhage coursed by interventions
  • Neonatal Behavioral Neurological Assessment [ Time Frame: 28days after birth ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bayley score [ Time Frame: 12 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy
  • Bayley score [ Time Frame: 18 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy
  • Peabody development measure scale [ Time Frame: 12 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy
  • Peabody development measure scale [ Time Frame: 18 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy
  • Number of death [ Time Frame: 1 years after birth ]
  • Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT [ Time Frame: 5 years after birth ]


Original Secondary Outcome: Same as current

Information By: Navy General Hospital, Beijing

Dates:
Date Received: April 27, 2014
Date Started: January 2013
Date Completion: December 2017
Last Updated: July 30, 2016
Last Verified: July 2016