UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009122 |
|---|---|
| Receipt number | R000010562 |
| Scientific Title | Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells |
| Date of disclosure of the study information | 2012/10/17 |
| Last modified on | 2016/12/03 09:25:11 |
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Basic information
Public title
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
Acronym
Liver Regeneration Therapy by Autologous Adipose Tissue Derived Stromal Cells
Scientific Title
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
Scientific Title:Acronym
Liver Regeneration Therapy by Autologous Adipose Tissue Derived Stromal Cells
Region
| Japan |
Condition
Condition
Liver Cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of administration of autologous adipose tissue derived stromal cells
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
assessment of safety in the context of adverse events defined in the implementation protocol
Key secondary outcomes
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
| Other |
Interventions/Control_1
intrahepatic arterial administration of autologous adipose tissue derived stromal cells (3.3 x 10^5 cells/Kg or 6.6 x 10^5 cells/Kg)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Criteria defined in the implementation protocol
Key exclusion criteria
Criteria defined in the implementation protocol
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University
Division name
Department of Gastroenterology
Zip code
Address
13-1 Takara-machi, Kanazawa, JAPAN
TEL
076-265-2000
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Sakai |
Organization
Kanazawa University
Division name
Department of Gastroenterology
Zip code
Address
13-1 Takara-machi, Kanazawa, JAPAN
TEL
076-265-2235
Homepage URL
yoshios@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01062750
Org. issuing International ID_1
the U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 17 | 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
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 22 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 07 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010562
