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Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

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ClinicalTrials.gov Identifier: NCT02455830
Recruitment Status : Unknown
Verified May 2015 by Neonatal Encephalopathy Consortium, Japan.
Recruitment status was:  Recruiting
First Posted : May 28, 2015
Last Update Posted : May 28, 2015
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 observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.

Condition or disease Intervention/treatment
Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy) Biological: Autologous cord blood cell therapy

Detailed Description:
The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.

Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy
Study Start Date : April 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : February 2018

Group/Cohort Intervention/treatment
Cell-treated
Infants with encephalopathy who receive autologous umbilical cord blood cell therapy along with therapeutic hypothermia.
Biological: Autologous cord blood cell therapy
The neonates receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12-24, 36-48, and 60-72 hours after the birth.

Cooled only
Infants with encephalopathy who receive therapeutic hypothermia only.



Primary Outcome Measures :
  1. Changes in serum levels of cytokines and trophic factors [ Time Frame: From birth up to 10 days of age ]

Secondary Outcome Measures :
  1. Association with neuroimaging and neurodevelopmental functional outcome [ Time Frame: 18 months ]
    Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be assessed whether they are associated with serum levels of cytokines and trophic factors during the early neonatal period.



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with encephalopathy who meet the inclusion criteria of therapeutic hypothermia, either those who receive the cell therapy or those who do not.
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. 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. Infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia 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): NCT02455830


Contacts
Contact: Yoshiaki Sato, MD, PhD +81-52-741-2111 yoshiaki@med.nagoya-u.ac.jp
Contact: Masahiro Tsuji, MD, PhD +81-6-6833-5012 tsuji.masahiro.ri@ncvc.go.jp

Locations
Japan
Nagoya University Hospital Recruiting
Nagoya, Aichi, Japan, 466-8560
Contact: Yoshiaki Sato, MD, PhD    +81-52-744-2294    yoshiaki@med.nagoya-u.ac.jp   
Principal Investigator: Masahiro Hayakawa, MD, PhD         
Sub-Investigator: Yoshiaki Sato, MD, PhD         
Kurashiki Central Hospital Recruiting
Kurashiki, Okayama, Japan, 710-8602
Contact: Mariko Sawada, MD    +81-86-422-0210    ms12307@kchnet.or.jp   
Principal Investigator: Shinichi Watabe, MD         
Sub-Investigator: Mariko Sawada, MD         
Saitama Medical Center Recruiting
Kawagoe, Saitama, Japan, 350-0495
Contact: Masanori Tamura, MD, PhD    +81-49-228-3400    mstamura@saitama-med.ac.jp   
Principal Investigator: Masanori Tamura, MD, PhD         
Yodogawa Christian Hospital Recruiting
Osaka, Japan, 533-0032
Contact: Makoto Nabetani, MD, PhD    +81-6-6322-2250    a103111@ych.or.jp   
Principal Investigator: Makoto Nabetani, MD, PhD         
Osaka City General Hospital Recruiting
Osaka, Japan, 534-0021
Contact: Hiroyuki Ichiba, MD, PhD    +81-6-6929-1221    h-ichiba@med.osaka-cu.ac.jp   
Principal Investigator: Hiroyuki Ichiba, MD, PhD         
Osaka City University Hospital 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 Graduate School of Medicine

Responsible Party: Neonatal Encephalopathy Consortium, Japan
ClinicalTrials.gov Identifier: NCT02455830     History of Changes
Other Study ID Numbers: UMIN000014903-Cytokines
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Neonatal Encephalopathy Consortium, Japan:
Neonatal encephalopathy
Hypoxic-ischemic encephalopathy
Newborn infants
Cytokines
Trophic factors

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