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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022601
Receipt No. R000026052
Scientific Title Open-label and uncontrolled clinical trial by multicenter for liver regenerative therapy for liver cirrhosis using autologous subcutaneous adipose tissue-derived regenerative(stem) cells to assess efficacy and safety
Date of disclosure of the study information 2016/07/01
Last modified on 2019/06/13

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Basic information
Public title Open-label and uncontrolled clinical trial by multicenter for liver regenerative therapy for liver cirrhosis using autologous subcutaneous adipose tissue-derived regenerative(stem) cells to assess efficacy and safety
Acronym Clinical trial of liver regenerative therapy using autologous adipose tissue-derived regenerative cells
Scientific Title Open-label and uncontrolled clinical trial by multicenter for liver regenerative therapy for liver cirrhosis using autologous subcutaneous adipose tissue-derived regenerative(stem) cells to assess efficacy and safety
Scientific Title:Acronym Clinical trial of liver regenerative therapy using autologous adipose tissue-derived regenerative cells
Region
Japan

Condition
Condition liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of efficacy and safety of autologous adipose tissue-derived regenerative (stem) cell therapy delivered to the liver via hepatic artery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes serum albumin concentration, prothrombin activity, harmful event, malfunction
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 regenerative (stem) cells (3.3x10^5 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 clinical trial implementation protocol
Key exclusion criteria Criteria defined in the clinical trial implementation protocol
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Kaneko
Organization Kanazawa University
Division name College of Medical, Pharmaceutical and Health Sciences
Zip code 9208641
Address 13-1 Takara-machi, Kanazawa, JAPAN
TEL 076-265-2235
Email skaneko@m-kanazawa.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Sakai
Organization Kanazawa University
Division name College of Medical, Pharmaceutical and Health Sciences
Zip code 9208641
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 AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka Medical University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Innovative Clinical Research Center, Kanazawa University
Address 13-1 Takara-machi, Kanazawa
Tel 076-265-2090
Email irb@adm.kanazawa-u.ac.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 金沢大学附属病院、大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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
registration initiated
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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 10 Day
Date of IRB
2016 Year 04 Month 18 Day
Anticipated trial start date
2017 Year 10 Month 12 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
2019 Year 12 Month 30 Day
Date trial data considered complete
2020 Year 02 Month 28 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 04 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026052

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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