Trial | NCT02854579  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
Study Started
Jan 31
2013
Primary Completion
Jul 31
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Aug 03
2016
Estimate

Biological neural progenitor cell

Neural progenitor cells are derived from the same aborted human fetal forebrain.

Biological Paracrine factors

The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times

  • Other names: paracrine factor of human mesenchymal stem cells

Biological progenitor cell and paracrine factors

Neural progenitor cells will be received after paracrine factors therapy

Neural progenitor cell Experimental

Three doses of Neural progenitor cell (4*10^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy

Paracrine factors Experimental

Three doses of concentrated paracrine factors of human mesenchymal stem cell （0.5ml） intrathecally at 12h,24h,48h after birth.+routine therapy

Progenitor cell and paracrine factors Experimental

Three doses of concentrated paracrine factors 0.5ml intrathecally at 12h,24h,48h after birth.And three doses of neural progenitor cell (4*10^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy

Routine therapy No Intervention

neonates only receive routine therapy

Criteria 

Inclusion Criteria:

gestational age ≥ 34weeks, body weight ≥ 2kg.
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.
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:

Does not meet the inclusion criteria
Suffer from other serious organic disease or congenital, hereditary metabolic diseases
Intracranial active infection, or neuromuscular damage outside central nervous system
potential of hydrogen / electrolyte disorders without improvement or stability
Coagulation disorders associated with bleeding tendency
Immune function is not perfect
Patients or his guardian refuse consent.
Patients or his guardian don't accept the follow-up schedule.
No Results Posted