UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A safety and efficacy study of autologous bone marrow cell transplantation for cirrhosis of liver caused by lifestyle related disease
Title of the study (Brief title)	ABMi therapy for liver cirrhosis(lifestyle related disease )
Region	Japan

Condition
Condition	Cirrhosis of liver caused by lifestyle related disease(Including NASH)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze and evaluate liver functions if autologous bone marrow cell transplantation can safely restore them for cirrhosis of liver caused by lifestyle related disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the following outcomes at the point of 24 weeks after the transplantation.For Child-Pugh Score: -2 reduction or more as improvement, change range within 1 as no change, +2 increase or more as worsening, respectively from the score before the transplantation. Also evaluate statistical significance between pre-transplantation and 24 weeks after. For serum albumin and fibrosis markers: 10% changes before and after as improvement or worsening. Also evaluate statistical significance between pre-transplantation and 24 weeks after. For image evaluation: Three degrees of ascites (non. mild, moderate dose and over) as in Child-Pugh Score with improvement as one or more degree improvement. For self-reporting subjective symptoms: Compare bottom-line scores of each sub-categorical scale in SF health score card. About improvement and no change: Because cirrhosis is a progressive condition treatment,efficacy is defined by improvement and no change in the above outcomes.
Key secondary outcomes	The duration of the treatment effectiveness. Using the same evaluation modules as of the primary outcomes, investigate and assess the chronological effectivity after the primal 24 weeks up to 48 weeks to evaluate the duration of the treatment efficacy

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	One's own autologous bone marrow cell transplantation
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Cirrhosis of liver caused by lifestyle related disease(Alcoholic cirrhosis or NASH) (2)Between 20 and 70 of age (3)Have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B (5)Able to consent and willing to participate in this study Note: The diagnosis of the alcoholic cirrhosis keep the diagnostic criteria(hepatic34:888-896:1993)of the JSH, and the diagnosis of the NASH cirrhosis also do the diagnostic criteria(hepatic48:2007)of the JSH. 1) Ethanol intakes are less than 20g/day. 2) Other causes to cause a liver damage are not clear. 3) The state of the fatty liver caused by obesity, especially visceral fat obesity, metabolic syndrome, and the diabetes complications.
Key exclusion criteria	1) Hepatocellular carcinoma (HCC), except for cases having been treated completely without history of recurrence 2) Maligi1ant tumor other than HCC 3) Total bilirubin under 3mg/dL 4) Hemoglobin under 8g/dl or Platelets under 50000/ul at the registration 5) Esophageal or gastric varices with a risk of bursting, except for cases only with cured history of such conditions 6) Renal dysfunction with 2mg/dl or higher serum creatinine 7) Less than six months after abstaining from alcoholic in alcoholic cirrhosis. 8) Cases that cannot obtain the informed consent to autologous blood transfusion 9) Pregnancy 10)Performance Status 3 or 4 11) Not fit for general anesthesia 12) Other conditions that doctor considered not suitable for this study
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroshi Sakugawa
Organization	Heart life hospital
Division name	Department of internal medicine
Address	208 ijyu nakagusuku nakagami Okinawa Japan
TEL	098-895-3255
Email	h.sakugawa@heartlife.or.jp

Public contact
Name of contact person	Daisuke Shibata
Organization	Heart life hospital
Division name	gastroenterological medicine
Address	208 ijyu nakagusuku nakagami Okinawa Japan
TEL	098-895-3255
Homepage URL
Email	daisakimei@yahoo.co.jp

Sponsor
Institute	Heart life hospital
Institute
Department

Funding Source
Organization	Okinawa prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	社会医療法人かりゆし会　ハートライフ病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 09 Month 28 Day
Anticipated trial start date	2013 Year 01 Month 25 Day
Last follow-up date	2016 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 25 Day
Last modified on	2016 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017731