UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022251
Receipt number R000025641
Scientific Title Basic Researches for the development of regenerative medicine about human adipose-derived regenerative cells (ADRCs)
Date of disclosure of the study information 2016/05/09
Last modified on 2019/05/13 08:49:37

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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

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

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 or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025641


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name