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Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

Primary Purpose

Neonatal Encephalopathy, Hypoxic-ischemic Encephalopathy

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Autologous umbilical cord blood cells

About this trial

This is an interventional treatment trial for Neonatal Encephalopathy focused on measuring neonatal encephalopathy, hypoxic-ischemic encephalopathy, newborn infants, neonates, umbilical cord blood cells

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Infants are eligible if they meet all the following inclusion criteria except 4.

≥36 weeks gestation
Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH <7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
Moderate to severe encephalopathy (Sarnat II to III)
A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
Up to 24 hours of age
Autologous umbilical cord blood available to infuse within 3 days after birth
A person with parental authority must have consented for the study.

Exclusion Criteria:

Known major congenital anomalies, such as chromosomal anomalies, heart diseases
Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
Severe growth restriction, with birth-weight less than 1800 g
Severe infectious disease, such as sepsis
Hyperkalemia
Outborn infants (Infants born at hospitals other than the study sites)
Volume of collected cord blood <40 ml
Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

Sites / Locations

Nagoya University Hospital
Kurashiki Central Hospital
Saitama Medical University
Yodogawa Christian Hospital
Osaka City General Hospital
Osaka City University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cell therapy

Arm Description

Infants who are born at the study sites, have moderate to severe encephalopathy, and have cord blood available for infusion

Outcomes

Primary Outcome Measures

Adverse event rates

Adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) will be compared between the cell recipients and historical controls at 30 days of age.

Secondary Outcome Measures

Efficacy

Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be compared between the cell recipients and historical controls.

Full Information

NCT ID

NCT02256618

First Posted

October 1, 2014

Last Updated

October 28, 2019

Sponsor

Neonatal Encephalopathy Consortium, Japan

Collaborators

Osaka City University, Yodogawa Christian Hospital, Kurashiki Central Hospital, Nagoya University, Osaka City General Hospital, Saitama Medical University, National Cerebral and Cardiovascular Center, Japan, National Center for Child Health and Development, Japan, Tokyo University, Tokyo Women's Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02256618

Brief Title

Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

Official Title

A Pilot Feasibility and Safety Study of Autologous Umbilical Cord Blood Cell Therapy in Infants With Neonatal Encephalopathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neonatal Encephalopathy Consortium, Japan

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.

Detailed Description

This is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. Infants will be followed for safety and neurodevelopmental outcome up to 18 months.

6. Conditions and Keywords

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

Neonatal Encephalopathy, Hypoxic-ischemic Encephalopathy

Keywords

neonatal encephalopathy, hypoxic-ischemic encephalopathy, newborn infants, neonates, umbilical cord blood cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cell therapy

Arm Type

Experimental

Arm Description

Infants who are born at the study sites, have moderate to severe encephalopathy, and have cord blood available for infusion

Intervention Type

Other

Intervention Name(s)

Autologous umbilical cord blood cells

Intervention Description

Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused

Primary Outcome Measure Information:

Title

Adverse event rates

Description

Adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) will be compared between the cell recipients and historical controls at 30 days of age.

Time Frame

first 30 postnatal days

Secondary Outcome Measure Information:

Title

Efficacy

Description

Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be compared between the cell recipients and historical controls.

Time Frame

18 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

24 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infants are eligible if they meet all the following inclusion criteria except 4. ≥36 weeks gestation Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH <7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth Moderate to severe encephalopathy (Sarnat II to III) A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored Up to 24 hours of age Autologous umbilical cord blood available to infuse within 3 days after birth A person with parental authority must have consented for the study. Exclusion Criteria: Known major congenital anomalies, such as chromosomal anomalies, heart diseases Major intracranial hemorrhage identified by brain ultrasonography or computed tomography Severe growth restriction, with birth-weight less than 1800 g Severe infectious disease, such as sepsis Hyperkalemia Outborn infants (Infants born at hospitals other than the study sites) Volume of collected cord blood <40 ml Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haruo Shintaku, MD, PhD

Organizational Affiliation

Osaka City University

Official's Role

Study Director

Facility Information:

Facility Name

Nagoya University Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Kurashiki Central Hospital

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8602

Country

Japan

Facility Name

Saitama Medical University

City

Kawagoe

State/Province

Saitama

ZIP/Postal Code

350-0495

Country

Japan

Facility Name

Yodogawa Christian Hospital

City

Osaka

ZIP/Postal Code

533-0032

Country

Japan

Facility Name

Osaka City General Hospital

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Osaka City University

City

Osaka

ZIP/Postal Code

545-8585

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24444827

Citation

Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18.

Results Reference

background

PubMed Identifier

25034178

Citation

Ohshima M, Taguchi A, Tsuda H, Sato Y, Yamahara K, Harada-Shiba M, Miyazato M, Ikeda T, Iida H, Tsuji M. Intraperitoneal and intravenous deliveries are not comparable in terms of drug efficacy and cell distribution in neonatal mice with hypoxia-ischemia. Brain Dev. 2015 Apr;37(4):376-86. doi: 10.1016/j.braindev.2014.06.010. Epub 2014 Jul 14.

Results Reference

background

PubMed Identifier

15286799

Citation

Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.

Results Reference

background

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Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

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