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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009122
Receipt No. 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

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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
Email 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
Email yoshios@m-kanazawa.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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