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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014903
Receipt No. R000017162
Official scientific title of the study A pilot feasibility and safety study of autologous umbilical cord blood cell therapy in infants with neonatal encephalopathy
Date of disclosure of the study information 2014/08/26
Last modified on 2015/08/20

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Basic information
Official scientific title of the study A pilot feasibility and safety study of autologous umbilical cord blood cell therapy in infants with neonatal encephalopathy
Title of the study (Brief title) 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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Haruo Shintaku
Organization Osaka City University Graduate School of Medicine
Division name Department of Pediatrics
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 Makoto Nabetani
Organization Yodogawa Christian Hospital
Division name Hospice-Children's Hospice Hospital
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 06 Month 10 Day
Anticipated trial start date
2014 Year 08 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 08 Month 20 Day
Last modified on
2015 Year 08 Month 20 Day


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


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