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Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

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ClinicalTrials.gov Identifier: NCT02256618
Recruitment Status : Unknown
Verified October 2014 by Neonatal Encephalopathy Consortium, Japan.
Recruitment status was:  Recruiting
First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Collaborators:
Osaka City University
Yodogawa Christian Hospital
Kurashiki Central Hospital
Nagoya University
Osaka City General Hospital
Saitama Medical University
National Cerebral and Cardiovascular Center
National Center for Child Health and Development, Japan
Tokyo University
Tokyo Women's Medical University
Information provided by (Responsible Party):
Neonatal Encephalopathy Consortium, Japan

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.

Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Hypoxic-ischemic Encephalopathy Other: Autologous umbilical cord blood cells Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility and Safety Study of Autologous Umbilical Cord Blood Cell Therapy in Infants With Neonatal Encephalopathy
Study Start Date : August 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Cell therapy
Infants who are born at the study sites, have moderate to severe encephalopathy, and have cord blood available for infusion
Other: Autologous umbilical cord blood cells
Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused




Primary Outcome Measures :
  1. Adverse event rates [ Time Frame: first 30 postnatal days ]
    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 :
  1. Efficacy [ Time Frame: 18 months ]
    Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be compared between the cell recipients and historical controls.



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. ≥36 weeks gestation
  2. 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
  3. Moderate to severe encephalopathy (Sarnat II to III)
  4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
  5. Up to 24 hours of age
  6. Autologous umbilical cord blood available to infuse within 3 days after birth
  7. A person with parental authority must have consented for the study.

Exclusion Criteria:

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

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): NCT02256618


Contacts
Contact: Makoto Nabetani, MD, PhD +81-6-6322-2250 a103111@ych.or.jp
Contact: Masahiro Tsuji, MD, PhD +81-6-6833-5012 ext 2362 tsuji.masahiro.ri@ncvc.go.jp

Locations
Japan
Nagoya University Hospital Recruiting
Nagoya, Aichi, Japan, 466-8560
Principal Investigator: Masahiro Hayakawa, MD, PhD         
Sub-Investigator: Yoshiaki Sato, MD, PhD         
Kurashiki Central Hospital Recruiting
Kurashiki, Okayama, Japan, 710-8602
Principal Investigator: Shinichi Watabe, MD         
Saitama Medical University Recruiting
Kawagoe, Saitama, Japan, 350-0495
Principal Investigator: Masanori Tamura, MD, PhD         
Yodogawa Christian Hospital Recruiting
Osaka, Japan, 533-0032
Principal Investigator: Makoto Nabetani, MD, PhD         
Osaka City General Hospital Recruiting
Osaka, Japan, 534-0021
Principal Investigator: Hiroyuki Ichiba, MD, PhD         
Osaka City University Recruiting
Osaka, Japan, 545-8585
Contact: Haruo Shintaku, MD, PhD    +81-6-6645-3816    shintakuh@med.osaka-cu.ac.jp   
Principal Investigator: Haruo Shintaku, MD, PhD         
Sub-Investigator: Takashi Hamazaki, MD, PhD         
Sponsors and Collaborators
Neonatal Encephalopathy Consortium, Japan
Osaka City University
Yodogawa Christian Hospital
Kurashiki Central Hospital
Nagoya University
Osaka City General Hospital
Saitama Medical University
National Cerebral and Cardiovascular Center
National Center for Child Health and Development, Japan
Tokyo University
Tokyo Women's Medical University
Investigators
Study Director: Haruo Shintaku, MD, PhD Osaka City University

Publications:
Responsible Party: Neonatal Encephalopathy Consortium, Japan
ClinicalTrials.gov Identifier: NCT02256618     History of Changes
Other Study ID Numbers: UMIN000014903
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014

Keywords provided by Neonatal Encephalopathy Consortium, Japan:
neonatal encephalopathy
hypoxic-ischemic encephalopathy
newborn infants
neonates
umbilical cord blood cells

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain