UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A safety and efficacy study of autologous bone marrow cell transplantation for HIV positive patients with cirrhosis
Title of the study (Brief title)	ABMi liver regeneration project
Region	Japan

Condition
Condition	HIV infection, AIDS, Cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analyze and evaluate if autologous bone marrow transplantation can safely restore liver functions for HIV infected patients who have cirrhosis.
Basic objectives2	Others
Basic objectives -Others	Investigate how long the efficacy of the treatment will last.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcomes are treatment safety and efficacy 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". Evaluate statistical significance of albumin and Transient Elastography between the pre-transplantation and the 24 weeks after. For image evaluation, three degrees of ascites [none, mild, severe] 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. Because cirrhosis is a progressive condition, treatment efficacy is defined by "improvement" and "no change" from the above.
Key secondary outcomes	The key secondary outcomes is 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	Autologous bone marrow 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	Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine and: 1) between 20 and 70 of age 2) have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B 3) able to consent and willing to participate in the study 4) under good control for HIV
Key exclusion criteria	Cases applicable to ANY condition of the following: 1) Hepatocellular carcinoma (HCC), except for cases having been treated completely without history of recurrence 2) Malignant tumor other than HCC 3) Alcoholic liver disease (ALD) 4) Hemoglobin under 8g/dL or Platelets under 20/ml at the registration 5) Esophageal or gastric varices with a risk of bursting, except for cases only with cured history of such conditions 6) Cases that cannot obtain the informed consent to autologous blood transfusion 7) Pregnancy 8) Renal dysfunction with 2mg/dL or higher serum creatinine 9) Performance Status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations) 10) not fit for general anesthesia 11) other conditions that doctor considered not suitable for the study
Target sample size	10

Research contact person
Name of lead principal investigator	Shinichi Oka
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Address	1-21-1 Toyama, Shinjuku, Tokyo JAPAN
TEL	03-5273-5193
Email	oka@acc.ncgm.go.jp

Public contact
Name of contact person	Kunihisa Tsukada
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Address	1-21-1 Toyama, Shinjuku, Tokyo JAPAN
TEL	03-3202-7181(5369)
Homepage URL
Email	ktsukada@acc.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01309594
Org. issuing International ID_1	NIH
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立国際医療研究センター病院（東京都）、山口大学医学部附属病院（山口県）、奈良県立医科大学附属病院（奈良県）、国立病院機構岡山医療センター病院（岡山県）、東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2011 Year 03 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 04 Day
Anticipated trial start date	2011 Year 03 Month 01 Day
Last follow-up date	2016 Year 03 Month 01 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded

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

Management information
Registered date	2011 Year 03 Month 02 Day
Last modified on	2017 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006141