UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for the effectiveness and safety for Autologous Bone Marrow Cell infusion (ABMi) therapy for HCV infected liver cirrhosis patient.
Title of the study (Brief title)	ABMi therapy for liver cirrhosis (HCV)
Region	Japan

Condition
Condition	HCV infection, Liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of Autologous Bone Marrow Cell infusion therapy for HCV related liver cirrhosis patients compared with standard medical treatment (Child-Pugh Score)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of Child-Pugh score at 24 weeks after ABMi therapy and control
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Autologous Bone Marrow Cell infusion
Interventions/Control_2	Standard medical treatment
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Liver cirrhosis related with HCV infection (2) Liver cirrhosis with Child-Pugh Score (over 7) in Child-Pugh B persist for 90 more days, refractory to standard medical treatment (3) >=20 years old and <=75 years old (4) Patient must have signed the consent form
Key exclusion criteria	(1) Liver cirrhosis induced by other factor without HCV infection and unknown reasons (2) have a malignant neoplasm, or a history of malignant neoplasm (Including HCC) (3) have risk of Esophageal or/and gastric varices (4) Renal dysfunction with 2mg/dL or higher serum creatinine (5) hemoglobin under 8g/dL or Platelets under 50/mL or Prothrombin activity under 40% (6) Total bilirubin 3.0mg/dL or more (7) Performance Status 3 or 4 (8) Cases that cannot obtain the informed consent to autologous blood transfusion (9) undeniable possibility for HBV infection, HIV infection, ATL infection, human parvovirus B19 infection (10) Pregnancy (11) not fit for general anesthesia (12) have a severe allergic reaction to contrast dye or a history of a severe allergic reaction to contrast dye (13) other conditions that doctor considered not suitable for the study
Target sample size	34

Research contact person
Name of lead principal investigator	Isao Sakaida
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterology & Hepatology
Address	Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL	0836-22-2241
Email	sakaida@yamaguchi-u.ac.jp

Public contact
Name of contact person	Shuji Terai
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterology & Hepatology
Address	Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL	0836-22-2241
Homepage URL
Email	terais@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 06 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 14 Day
Last follow-up date
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	2013 Year 09 Month 04 Day
Last modified on	2018 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013624