UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015554 |
|---|---|
| Receipt number | R000018007 |
| Scientific Title | A study on the effects of culture supernatant of human somatic stem cells on diabetes mellitus |
| Date of disclosure of the study information | 2014/10/28 |
| Last modified on | 2019/05/03 20:21:45 |
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Basic information
Public title
A study on the effects of culture supernatant of human somatic stem cells on diabetes mellitus
Acronym
The effects of culture supernatant of human stem cells on diabetes mellitus
Scientific Title
A study on the effects of culture supernatant of human somatic stem cells on diabetes mellitus
Scientific Title:Acronym
The effects of culture supernatant of human stem cells on diabetes mellitus
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and efficacy of culture supernatant of human somatic stem cells on diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety: Adverse events and laboratory tests
Key secondary outcomes
Efficacy: Clinical symptoms and laboratory tests
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous or intranasal administration of culture supernatant of human somatic stem cells
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
Patients with diabetes mellitus under treatment
Treatment has not been changed in the previous month and it is anticipated that the treatment will not be changed in the next month
Patients with abnormal HbA1c
Key exclusion criteria
Patients with malignant diseases
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Megumu |
| Middle name | |
| Last name | Kanno |
Organization
Southern TOHOKU General Hospital
Division name
Cardiovascular Center
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima, 963-8563, Japan
TEL
024-934-5322
m.kanno@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Terunuma |
Organization
Southern TOHOKU Research Institute for Neuroscience
Division name
Clinical research center for regeneration factor
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima, 963-8563, Japan
TEL
024-934-5322
Homepage URL
terunuma.h@gmail.com
Sponsor or person
Institute
Southern TOHOKU General Hospital
Institute
Department
Personal name
Funding Source
Organization
Quarrymen Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Southern Tohoku General Hospital IRB
Address
7-115 Hachiyamada, Koriyama, Fukushima
Tel
024-934-5322
yousuke.mizuno@mt.strins.or.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
総合南東北病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 28 | 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
| 2013 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 28 | Day |
Last modified on
| 2019 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
