UMIN-CTR Clinical Trial

Basic information
Public title	A pilot feasibility and safety study of autologous umbilical cord blood cell therapy in infants with neonatal encephalopathy
Acronym	Autologous cord blood cell therapy for neonatal encephalopathy
Scientific Title	A pilot feasibility and safety study of autologous umbilical cord blood cell therapy in infants with neonatal encephalopathy
Scientific Title:Acronym	Autologous cord blood cell therapy for neonatal encephalopathy
Region	Japan

Condition
Condition	Neonatal encephalopathy (Neonatal hypoxic-ischemic encephalopathy)
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in infants with neonatal encephalopathy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Intravenous infusions (up to 3 infusions) of autologous volume reduced cord blood cells in the first 72 hours after birth
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	0 days-old <=
Age-upper limit	1 days-old >=
Gender	Male and Female
Key inclusion criteria	Infants are eligible if they meet all the following inclusion criteria except 4). 1) At least 36 weeks gestation 2) Either a 10-minute Apgar score 5 or less, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH <7.0 or base deficit 16 mmol/L or more 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.
Key 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
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Middle name Last name Haruo Shintaku
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Pediatrics
Zip code
Address	1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL	06-6645-3816
Email	shintakuh@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Nabetani
Organization	Yodogawa Christian Hospital
Division name	Hospice-Children's Hospice Hospital
Zip code
Address	6-9-3 Higashi-nakajima, Higashi-yodogawa-ku, Osaka 533-0033 Japan
TEL	06-6322-2250
Homepage URL
Email	a103111@ych.or.jp

Sponsor
Institute	Neonatal Encephalopathy Consortium, Japan
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Saitama Medical Center Nagoya University Hospital Osaka City General Hospital Osaka City University Hospital Yodogawa Christian Hospital Kurashiki Central Hospital National Cerebral and Cardiovascular Center National Center for Child Health and Development The Institute of Medical Science, The University of Tokyo Yodogawa Christian Hospital Kurashiki Central Hospital National Cerebral and Cardiovascular Center National Center for Child Health and Development The Institute of Medical Science, The University of Tokyo The University of Tokyo Tokyo Women's Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	埼玉医科大学総合医療センター 名古屋大学医学部附属病院 大阪市立総合医療センター 大阪市立大学医学部附属病院 淀川キリスト教病院 倉敷中央病院

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 06 Month 10 Day
Date of IRB	2014 Year 08 Month 06 Day
Anticipated trial start date	2014 Year 08 Month 26 Day
Last follow-up date	2019 Year 07 Month 26 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 07 Month 26 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 20 Day
Last modified on	2019 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017162