UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015251
Receipt number R000017731
Scientific Title A safety and efficacy study of autologous bone marrow cell transplantation for cirrhosis of liver caused by lifestyle related disease
Date of disclosure of the study information 2014/10/01
Last modified on 2016/10/01 14:49:23

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Basic information

Public title

A safety and efficacy study of autologous bone marrow cell transplantation for cirrhosis of liver caused by lifestyle related disease

Acronym

ABMi therapy for liver cirrhosis(lifestyle related disease )

Scientific Title

A safety and efficacy study of autologous bone marrow cell transplantation for cirrhosis of liver caused by lifestyle related disease

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroshi Sakugawa

Organization

Heart life hospital

Division name

Department of internal medicine

Zip code


Address

208 ijyu nakagusuku nakagami Okinawa Japan

TEL

098-895-3255

Email

h.sakugawa@heartlife.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Shibata

Organization

Heart life hospital

Division name

gastroenterological medicine

Zip code


Address

208 ijyu nakagusuku nakagami Okinawa Japan

TEL

098-895-3255

Homepage URL


Email

daisakimei@yahoo.co.jp


Sponsor or person

Institute

Heart life hospital

Institute

Department

Personal name



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)



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

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


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

No longer recruiting

Date of protocol fixation

2012 Year 09 Month 28 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017731


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name