UMIN-CTR Clinical Trial

Basic information
Public title	The safety and efficacy of Autologous adipose tissue derived mesenchymal stem cell on cirrhotic patients
Acronym	aipose tissue derived mesenchymal stem cell therapy for hepatitis and cirrhosis
Scientific Title	The safety and efficacy of Autologous adipose tissue derived mesenchymal stem cell on cirrhotic patients
Scientific Title:Acronym	aipose tissue derived mesenchymal stem cell therapy for hepatitis and cirrhosis
Region	Japan

Condition
Condition	liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency medicine Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, there is increasing basic research of adipose derived mesencymal stem cel therapy for liver cirrhosis. This study is aimed to elucidate the safety and efficacy on liver cirrhosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Liver function(Child-pugh score), respiratory function, general status (performance status), Biochemistry data, Coagulation status)
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	adipose derived mesenchymal stem cell infusion therapy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Cirrhosis is proven by CT and clinical status. 2.Over age of 20 years old. 3.the socre more thtan Child-Pugh score 6 4.Obtained informed consent
Key exclusion criteria	A.alcoholic patients B.sever heart disease C.pregnant patients D.malignant tumor such as HCC E.uncontrolled infectious disease F.impossible to obtain an informed consent G.The patient who primary investigator judged unsuitable
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Akahoshi
Organization	Kaizuka hospital
Division name	Department of surgery
Zip code	812-0053
Address	hakozaki 7-7-27, Higashi-ku, Fukuoka
TEL	0926426223
Email	tomohiko@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Tomohiko Middle name Last name Akahoshi
Organization	Department of disaster and emergency medicine
Division name	Surgery
Zip code	812-8582
Address	hakozaki 7-7-27, Higashi-ku, Fukuoka
TEL	0926426223
Homepage URL
Email	tomohiko@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Kaizuka hospital
Institute
Department

Funding Source
Organization	Self Funding
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	comittee of regenerative medicine, kurume chuo hospital
Address	Komorino 2-3-8, Kurume, Fukuoka, Japan
Tel	0942-35-1000
Email	k-chuo@soleil.ocn.ne.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	貝塚病院（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 16 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	2016 Year 06 Month 15 Day
Date of IRB	2016 Year 06 Month 15 Day
Anticipated trial start date	2017 Year 01 Month 16 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 09 Day
Last modified on	2020 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029436