UMIN-CTR Clinical Trial

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
Email	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
Email	fujiedam@kochi-u.ac.jp

Sponsor
Institute	Department of Pediatrics Kochi Medical School Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027230