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Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

Primary Purpose

Hypoxic-Ischemic Encephalopathy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

neural progenitor cell

Paracrine factors

progenitor cell and paracrine factors

About this trial

This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring Hypoxic-Ischemic Encephalopathy, progenitor cell, paracrine factor, adipose mesenchymal stem cell, neonate

Eligibility Criteria

1 Day - 14 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Navy General HospitalRecruiting
Navy General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Neural progenitor cell

Paracrine factors

Progenitor cell and paracrine factors

Routine therapy

Arm Description

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

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

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

neonates only receive routine therapy

Outcomes

Primary Outcome Measures

Neonatal Behavioral Neurological Assessment

number of adverse events

adverse events like fever、infection、seizures、hemorrhage coursed by interventions

Neonatal Behavioral Neurological Assessment

Secondary Outcome Measures

Bayley score

Gross motor function measure assessment for children diagnosed cerebral palsy

Bayley score

Gross motor function measure assessment for children diagnosed cerebral palsy

Peabody development measure scale

Gross motor function measure assessment for children diagnosed cerebral palsy

Peabody development measure scale

Gross motor function measure assessment for children diagnosed cerebral palsy

Number of death

Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT

Full Information

NCT ID

NCT02854579

First Posted

April 27, 2014

Last Updated

July 30, 2016

Sponsor

Navy General Hospital, Beijing

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

1. Study Identification

Unique Protocol Identification Number

NCT02854579

Brief Title

Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Navy General Hospital, Beijing

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxic-Ischemic Encephalopathy

Keywords

Hypoxic-Ischemic Encephalopathy, progenitor cell, paracrine factor, adipose mesenchymal stem cell, neonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neural progenitor cell

Arm Type

Experimental

Arm Description

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

Arm Title

Paracrine factors

Arm Type

Experimental

Arm Description

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

Arm Title

Progenitor cell and paracrine factors

Arm Type

Experimental

Arm Description

Arm Title

Routine therapy

Arm Type

No Intervention

Arm Description

neonates only receive routine therapy

Intervention Type

Biological

Intervention Name(s)

neural progenitor cell

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Paracrine factors

Other Intervention Name(s)

paracrine factor of human mesenchymal stem cells

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

progenitor cell and paracrine factors

Intervention Description

Neural progenitor cells will be received after paracrine factors therapy

Primary Outcome Measure Information:

Title

Neonatal Behavioral Neurological Assessment

Time Frame

14days after birth

Title

number of adverse events

Description

adverse events like fever、infection、seizures、hemorrhage coursed by interventions

Time Frame

7days after cell or factor injection

Title

Neonatal Behavioral Neurological Assessment

Time Frame

28days after birth

Secondary Outcome Measure Information:

Title

Bayley score

Description

Gross motor function measure assessment for children diagnosed cerebral palsy

Time Frame

12 months after birth

Title

Bayley score

Description

Gross motor function measure assessment for children diagnosed cerebral palsy

Time Frame

18 months after birth

Title

Peabody development measure scale

Description

Gross motor function measure assessment for children diagnosed cerebral palsy

Time Frame

12 months after birth

Title

Peabody development measure scale

Description

Gross motor function measure assessment for children diagnosed cerebral palsy

Time Frame

18 months after birth

Title

Number of death

Time Frame

1 years after birth

Title

Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT

Time Frame

5 years after birth

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zuo Luan, MD

Phone

18600317210

hjzyyerke@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Weipeng Liu, MD

Phone

13581797015

hjzyynicu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zuo Luan, MD

Organizational Affiliation

Navy General Hosiptal

Official's Role

Study Chair

Facility Information:

Facility Name

Navy General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100048

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zuo Luan, MD

hjzyyerke@163.com

First Name & Middle Initial & Last Name & Degree

Zuo Luan, MD

First Name & Middle Initial & Last Name & Degree

Weipeng Liu, MD

Facility Name

Navy General Hospital

City

Beijing

ZIP/Postal Code

100048

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zuo Luan, MD

Phone

18600310270

hjzyyerke@163.com

First Name & Middle Initial & Last Name & Degree

Weipeng Liu, MD

Phone

135581797015

hjzyynicu@163.com

First Name & Middle Initial & Last Name & Degree

Zuo Luan, MD

First Name & Middle Initial & Last Name & Degree

Weipeng Liu, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22507684

Citation

Luan Z, Liu W, Qu S, Du K, He S, Wang Z, Yang Y, Wang C, Gong X. Effects of neural progenitor cell transplantation in children with severe cerebral palsy. Cell Transplant. 2012;21 Suppl 1:S91-8. doi: 10.3727/096368912X633806.

Results Reference

background

PubMed Identifier

32813884

Citation

Bruschettini M, Romantsik O, Moreira A, Ley D, Thebaud B. Stem cell-based interventions for the prevention of morbidity and mortality following hypoxic-ischaemic encephalopathy in newborn infants. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD013202. doi: 10.1002/14651858.CD013202.pub2.

Results Reference

derived

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Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

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