UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014903 |
|---|---|
| Receipt number | R000017162 |
| Scientific Title | 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 | 2019/10/28 17:26:51 |
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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
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
a103111@ych.or.jp
Sponsor or person
Institute
Neonatal Encephalopathy Consortium, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017162
