UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035546 |
|---|---|
| Receipt number | R000039436 |
| Scientific Title | The differentiation of insulin producing cell from adipose tissue derived stromal cells |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/01/15 17:13:32 |
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Basic information
Public title
The differentiation of insulin producing cell from adipose tissue derived stromal cells
Acronym
The differentiation of insulin producing cell from adipose tissue derived stromal cells
Scientific Title
The differentiation of insulin producing cell from adipose tissue derived stromal cells
Scientific Title:Acronym
The differentiation of insulin producing cell from adipose tissue derived stromal cells
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Induce differentiation into insulin-producing cells and verify its mechanism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional evaluation of insulin-producing cells
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
The adipose-derived stromal cells isolated from human adipose tissue (subcutaneous fat tissue) are induced to differentiate into insulin-producing cells, and functional evaluation between the two groups is performed.
Interventions/Control_2
The adipose-derived stromal cells isolated from human adipose tissue (visceral fat tissue) are induced to differentiate into insulin-producing cells, and functional evaluation between the two groups is performed.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent abdominal surgery are included in current study.
Key exclusion criteria
Patients who can not obtain informed consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
Tokushima University
Division name
Digestive surgery
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7139
yumao9isi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuma Wada |
Organization
Tokushima University
Division name
Digestive surgery
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7139
Homepage URL
yumao9isi@gmail.com
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 15 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039436
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
