UMIN-CTR Clinical Trial

Basic information
Public title	Basic Researches for the development of regenerative medicine about human adipose-derived regenerative cells (ADRCs)
Acronym	Basic Researches about ADRCs
Scientific Title	Basic Researches for the development of regenerative medicine about human adipose-derived regenerative cells (ADRCs)
Scientific Title:Acronym	Basic Researches about ADRCs
Region	Japan

Condition
Condition	Stress Urinary Incontinence
Classification by specialty	Surgery in general Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze the characterization of autologous Adipose Derived Regenerative Cells (ADRCs). To explore the method for cell culture and preservation.
Basic objectives2	Others
Basic objectives -Others	Exploring the mechanism
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1)Cell count of ADRCs 2)Characterization of ADRCs by flow cytometry 3)Cytokine production of ADRCs 4)CFU assay of ADRCs 5)Differentiation into smooth muscle of ADRCs 6)Cytokine production of Urine 7)Relationship between 1)-6) and clinical study results.
Key secondary outcomes	1)Influence on soft agar colony formation assay of ADRCs 2)Effect on tumor cells of ADRCs 3)Exploring the method for cell culture and preservation of ADRCs

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with participation in following clinical study in Nagoya University Hospital -UMIN000006116 -UMIN000017901 and NCT02529865 2)Patients who are able to collect additional 100g fat 3)Male: age of 20 or above Female: age of 40 or above 4)Patients who are willing and able to give signed consent
Key exclusion criteria	1)Patients who are not able to participate in following clinical study in Nagoya University Hospital -UMIN000006116 -UMIN000017901 and NCT02529865 2)Any other patients whom the study investigator deemed ineligible to this study
Target sample size	56

Research contact person
Last name of lead principal investigator	1st name Masaaki Middle name Last name Mizuno
Organization	Nagoya University Hospital
Division name	Center for Advanced Medicine and Clinical Research
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2942
Email	mmizuno@med.nagoya-u.ac.jp

Public contact
1st name of contact person	1st name Shinobu Middle name Last name Shimizu
Organization	Nagoya University Hospital
Division name	Center for Advanced Medicine and Clinical Research
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2942
Homepage URL
Email	s-shimizu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Review Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-2479
Email	ethics@med.nagoya-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	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 09 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	19
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	2014 Year 10 Month 17 Day
Date of IRB	2014 Year 12 Month 10 Day
Anticipated trial start date	2015 Year 07 Month 30 Day
Last follow-up date	2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To analyze the characterization of autologous Adipose Derived Regenerative Cells (ADRCs).

Management information
Registered date	2016 Year 05 Month 09 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025641