Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

Not Applicable

• Conditions: Hypoxic-Ischemic Encephalopathy
• Interventions: Biological: neural progenitor cell; Biological: progenitor cell and paracrine factors; Biological: Paracrine factors

• Registration Number: NCT02854579
• Lead Sponsor: Navy General Hospital, Beijing

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 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-04-27
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-30
• Last Update Submitted: 2016-07-30
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neural progenitor cell	neural progenitor cell	Three doses of Neural progenitor cell (4\*10\^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy
Progenitor cell and paracrine factors	progenitor cell and paracrine factors	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
Paracrine factors	Paracrine factors	Three doses of concentrated paracrine factors of human mesenchymal stem cell （0.5ml） intrathecally at 12h,24h,48h after birth.+routine therapy

Primary Outcome Measures

Name	Time	Method
Neonatal Behavioral Neurological Assessment	28days after birth
number of adverse events	7days after cell or factor injection	adverse events like fever、infection、seizures、hemorrhage coursed by interventions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, China