UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
Title of the study (Brief title)	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	Shuichi Kaneko
Organization	Kanazawa University
Division name	Department of Gastroenterology
Address	13-1 Takara-machi, Kanazawa, JAPAN
TEL	076-265-2000
Email	skaneko@m-kanazawa.jp

Public contact
Name of contact person	Yoshio Sakai
Organization	Kanazawa University
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010562