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Recruitment status
Unique ID issued by UMIN UMIN000025582
Receipt No. R000029436
Scientific Title The safety and efficacy of Autologous adipose tissue derived mesenchymal stem cell on cirrhotic patients
Date of disclosure of the study information 2017/01/16
Last modified on 2017/01/09

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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
Middle name
Last name Akahoshi Tomohiko
Organization Kaizuka hospital
Division name Department of surgery
Zip code
Address hakozaki 7-7-27, Higashi-ku, Fukuoka
TEL 092-632-3333
Email tomohiko@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akahoshi Tomohiko
Organization Kaizuka hospital
Division name Surgery
Zip code
Address hakozaki 7-7-27, Higashi-ku, Fukuoka
TEL 092-632-6223
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
Address
Tel
Email

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
Date of protocol fixation
2016 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 16 Day
Last follow-up date
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
2017 Year 01 Month 09 Day


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

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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