UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004105 |
|---|---|
| Receipt number | R000004903 |
| Scientific Title | Clinical application of pancreatic islet transplantation from deceased donor |
| Date of disclosure of the study information | 2010/08/26 |
| Last modified on | 2010/08/26 15:43:48 |
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Basic information
Public title
Clinical application of pancreatic islet transplantation from deceased donor
Acronym
Clinical application of pancreatic islet transplantation from deceased donor
Scientific Title
Clinical application of pancreatic islet transplantation from deceased donor
Scientific Title:Acronym
Clinical application of pancreatic islet transplantation from deceased donor
Region
| Japan |
Condition
Condition
Diabetes typa 1
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the safety and the efficacy of islet transplantation treatment as a final purpose that freedom from insulin for type 1 diabetic recipient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the decrease of insulin
the stability of blood glucose
Key secondary outcomes
Amount of long-term development of diabetic complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We have to check the blood test and rejection occurrence several times for 5 years after islet transplantation.
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
| 5 | years-old | < |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients have
1. the necessity of insulin treatment because of the notable decrease of endogenous insulin
2. difficulty of blood glucose controlin spite of diabetes treatment
3. the age below 75 years old
4. enough informed concent about pancreas and islet transplantation including their family
5. the diabetes for more than 5 years
Key exclusion criteria
Patients have
a) the severe cardiac and/or liver disease
b) the alcohol poisoning
c) the malignant tumor
d) severe obesity
e) unteated retinopathy
f) other unsuitable reasons for transplantation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
Tokushima University Hospital
Division name
Department of Digestive and Transplantation Surgery
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-7137
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Ikemoto |
Organization
Tokushima University Hospital
Division name
Department of Digestive and Transplantation Surgery
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-7139
Homepage URL
Sponsor or person
Institute
Department of Digestive and Transplantation Surgery, Tokushima University Hospital
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
| 2010 | Year | 08 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | 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
| 2010 | Year | 08 | Month | 26 | Day |
Last modified on
| 2010 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004903
