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
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
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
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
