Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

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

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

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.

Inclusion Criteria:

1. gestational age ≥ 34weeks, body weight ≥ 2kg.
2. 1 minute apgar score ≤3, and 5 minutes apgar score ≤5, OR umbilical arterial blood gas potential of hydrogen<7.0, OR 30 minutes base excess≤-12 mmol/L, OR need for ventilation 5 minutes after birth.
3. All infants must have signs of encephalopathy (such as convulsion, coma, dystonia, abnormal primitive reflex and irregular respiration) within 6 hours of age or continued abnormal EEG for more than 24h.

Exclusion Criteria:

1. Does not meet the inclusion criteria
2. Suffer from other serious organic disease or congenital, hereditary metabolic diseases
3. Intracranial active infection, or neuromuscular damage outside central nervous system
4. potential of hydrogen / electrolyte disorders without improvement or stability
5. Coagulation disorders associated with bleeding tendency
6. Immune function is not perfect
7. Patients or his guardian refuse consent.
8. Patients or his guardian don't accept the follow-up schedule.