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Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02854579
Recruitment Status : Unknown
Verified July 2016 by Zuo Luan, Navy General Hospital, Beijing.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborators:
Bethune International Peace Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Hunan Children's Hospital
Shangluo Central Hospital
252 Military Hospital
Information provided by (Responsible Party):
Zuo Luan, 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

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Biological: neural progenitor cell Biological: Paracrine factors Biological: progenitor cell and paracrine factors Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Neural progenitor cell
Three doses of Neural progenitor cell (4*10^6) intrathecally at 48-72h, 5d and 10d after birth.+routine therapy
Biological: neural progenitor cell
Neural progenitor cells are derived from the same aborted human fetal forebrain.

Experimental: Paracrine factors
Three doses of concentrated paracrine factors of human mesenchymal stem cell (0.5ml) intrathecally at 12h,24h,48h after birth.+routine therapy
Biological: Paracrine factors
The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
Other Name: paracrine factor of human mesenchymal stem cells

Experimental: 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
Biological: progenitor cell and paracrine factors
Neural progenitor cells will be received after paracrine factors therapy

No Intervention: Routine therapy
neonates only receive routine therapy



Primary Outcome Measures :
  1. Neonatal Behavioral Neurological Assessment [ Time Frame: 14days after birth ]
  2. number of adverse events [ Time Frame: 7days after cell or factor injection ]
    adverse events like fever、infection、seizures、hemorrhage coursed by interventions

  3. Neonatal Behavioral Neurological Assessment [ Time Frame: 28days after birth ]

Secondary Outcome Measures :
  1. Bayley score [ Time Frame: 12 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy

  2. Bayley score [ Time Frame: 18 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy

  3. Peabody development measure scale [ Time Frame: 12 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy

  4. Peabody development measure scale [ Time Frame: 18 months after birth ]
    Gross motor function measure assessment for children diagnosed cerebral palsy

  5. Number of death [ Time Frame: 1 years after birth ]
  6. Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT [ Time Frame: 5 years after birth ]


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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854579


Contacts
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Contact: Zuo Luan, MD 18600317210 hjzyyerke@163.com
Contact: Weipeng Liu, MD 13581797015 hjzyynicu@163.com

Locations
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China, Beijing
Navy General Hospital Recruiting
Beijing, Beijing, China, 100048
Contact: Zuo Luan, MD       hjzyyerke@163.com   
Principal Investigator: Zuo Luan, MD         
Sub-Investigator: Weipeng Liu, MD         
China
Navy General Hospital Recruiting
Beijing, China, 100048
Contact: Zuo Luan, MD    18600310270    hjzyyerke@163.com   
Contact: Weipeng Liu, MD    135581797015    hjzyynicu@163.com   
Principal Investigator: Zuo Luan, MD         
Sub-Investigator: Weipeng Liu, MD         
Sponsors and Collaborators
Navy General Hospital, Beijing
Bethune International Peace Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Hunan Children's Hospital
Shangluo Central Hospital
252 Military Hospital
Investigators
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Study Chair: Zuo Luan, MD Navy General Hosiptal

Publications:
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Responsible Party: Zuo Luan, Principal Investigator, Navy General Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02854579     History of Changes
Other Study ID Numbers: NavyGHB-P-01
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zuo Luan, Navy General Hospital, Beijing:
Hypoxic-Ischemic Encephalopathy
progenitor cell
paracrine factor
adipose mesenchymal stem cell
neonate

Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Hypoxia, Brain
Ischemia
Hypoxia
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases