UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024852 |
|---|---|
| Receipt number | R000027230 |
| Scientific Title | Autologous umbilical cord blood (UCB) infusion registaration for cerebral palsy or cerebral damage in Kochi |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2021/05/22 13:29:33 |
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Basic information
Public title
Autologous umbilical cord blood (UCB) infusion registaration for cerebral palsy or cerebral damage in Kochi
Acronym
CBReCK
Scientific Title
Autologous umbilical cord blood (UCB) infusion registaration for cerebral palsy or cerebral damage in Kochi
Scientific Title:Acronym
CBReCK
Region
| Japan |
Condition
Condition
Cerebral palsy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety in autologous UBC infusion for cerebral palsy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation of safety
Key secondary outcomes
Evaluation of beneficial change for developemental and motor disorders
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
autologous umbilical cord blood (UCB)
Single venous injection of UCB with 100ml of saline solution over 1 hr
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
| Not applicable |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases meet two requirements as follows:
1. Cases under 7 year-old-age
1)Cerebral palsy, or
2)Moderate or severe type of hypoxic ishchemic encephalopathy, or
3)Periventricular leukomalacia
2.Cases with stored autologous UCB
Cord blood mononuclear cell counts is over 1.2E+06 cells and its viability is over 60 percentage.
Key exclusion criteria
cases meet one of 7 requiremente as follows:
1)Gene anomaly
2)Malignancy
3)Mother with positive for B and C type hepatitis, or HIV, or HTLV-1, or sphilis
4)Steroid allergy
5)UCB with positive for bacterias
6)Cases decided to be inappropriate by doctors
7)Cases without consent
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Mikiya |
| Middle name | |
| Last name | Fujieda |
Organization
Kochi Medical School Hospital
Division name
Department of Pediatrics
Zip code
783-8505
Address
185-1 Kohasu Ok-cho Nankoku Kochi 785-8505 Japan
TEL
088-880-2355
fujiedam@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Mikiya |
| Middle name | |
| Last name | Fujieda |
Organization
Kochi Medical School Hospital
Division name
Department of Pediatrics
Zip code
783-8505
Address
185-1 Kohasu Ok-cho Nankoku Kochi 785-8505 Japan
TEL
088-880-2355
Homepage URL
fujiedam@kochi-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics
Kochi Medical School Hospital
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Deoartment of Pediatrics, Kochi Medical School, Kochi University
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
Tel
088-880-2355
fujiedam@kochi-u.ac.jp
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
高知大学医学部附属病院(高知県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 01 | 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
6
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 21 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 21 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 15 | Day |
Last modified on
| 2021 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027230
