NCT02854579

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Navy General Hospital, Beijing · Academic / Other
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
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
BIOLOGICAL	progenitor cell and paracrine factors	Neural progenitor cells will be received after paracrine factors therapy

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2016-08-03
• Last updated: 2016-08-03

Locations

2 sites across 1 country: China