Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

Hypoxic-Ischemic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854579
• Other study ID #: NavyGHB-P-01
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2014
• Last updated: July 30, 2016
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Navy General Hospital, Beijing
• Contact: Zuo Luan, MD
• Phone: 18600317210
• Email: hjzyyerke[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

Biological:
• neural progenitor cell
Neural progenitor cells are derived from the same aborted human fetal forebrain.
• Paracrine factors
The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
• progenitor cell and paracrine factors
Neural progenitor cells will be received after paracrine factors therapy

Locations

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing
China	Navy General Hospital	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing	252 Military Hospital, Bethune International Peace Hospital, Daping Hospital of Third Military Medical University, Hunan Children's Hospital, Shangluo Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Behavioral Neurological Assessment		14days after birth	No
Primary	number of adverse events	adverse events like fever?infection?seizures?hemorrhage coursed by interventions	7days after cell or factor injection	Yes
Primary	Neonatal Behavioral Neurological Assessment		28days after birth	No
Secondary	Bayley score	Gross motor function measure assessment for children diagnosed cerebral palsy	12 months after birth	No
Secondary	Bayley score	Gross motor function measure assessment for children diagnosed cerebral palsy	18 months after birth	No
Secondary	Peabody development measure scale	Gross motor function measure assessment for children diagnosed cerebral palsy	12 months after birth	No
Secondary	Peabody development measure scale	Gross motor function measure assessment for children diagnosed cerebral palsy	18 months after birth	No
Secondary	Number of death		1 years after birth	No
Secondary	Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT		5 years after birth	Yes