UMIN-CTR Clinical Trial

Basic information
Public title	Research of cell culture perichondrium for clinical use
Acronym	Research of cell culture perichondrium for clinical use
Scientific Title	Research of cell culture perichondrium for clinical use
Scientific Title:Acronym	Research of cell culture perichondrium for clinical use
Region	Japan

Condition
Condition	Congenital malformations craniomaxillofacial
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the optimal conditions for culturing stem-progenitor cells in autologous serum human cartilage toward the clinical application
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proliferative capacity and chondrogenic differentiation potential when cultured in serum autologous stem / progenitor cells human auricular cartilage
Key secondary outcomes

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	Prevention
Type of intervention	Other
Interventions/Control_1	Blood collection and harvesting of auricular cartilage
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	1 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Those who agreed to collect the blood of self in patients having congenital craniomaxillofacial deformities such as microtia, surgery with resection of the cartilage of the self
Key exclusion criteria	Patients with blood disorders and/or anemia observed in patients with preoperative screening has been pointed out already
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jiro Maegawa
Organization	Yokohama city university hospital
Division name	Dept. of plastic and reconstructive surgery
Zip code
Address	Fukuura3-9, Kanazawa-ku, Yokohama, Kanagawa, JAPAN
TEL	045-787-2709
Email	prs_ycu@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuichiro Yabuki
Organization	Yokhama city university
Division name	Dept. of Plastic and Reconstructive surgery
Zip code
Address	Fukuura3-9, Kanazawa-ku, Yokohama, Kanagawa, JAPAN
TEL	045-787-2709
Homepage URL
Email	yu1rou@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 11 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
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	2018 Year 04 Month 01 Day
Date of IRB	2014 Year 07 Month 06 Day
Anticipated trial start date	2016 Year 06 Month 30 Day
Last follow-up date	2017 Year 07 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2020 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010738