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 |
A safety and efficacy study of autologous bone marrow cell transplantation for cirrhosis of liver caused by lifestyle related disease
ABMi therapy for liver cirrhosis(lifestyle related disease )
A safety and efficacy study of autologous bone marrow cell transplantation for cirrhosis of liver caused by lifestyle related disease
ABMi therapy for liver cirrhosis(lifestyle related disease )
Japan |
Cirrhosis of liver caused by lifestyle related disease(Including NASH)
Hepato-biliary-pancreatic medicine |
Others
NO
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.
Safety,Efficacy
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.
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
One's own autologous bone marrow cell transplantation
20 | years-old | <= |
70 | years-old | >= |
Male and Female
(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.
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
10
1st name | |
Middle name | |
Last name | Hiroshi Sakugawa |
Heart life hospital
Department of internal medicine
208 ijyu nakagusuku nakagami Okinawa Japan
098-895-3255
h.sakugawa@heartlife.or.jp
1st name | |
Middle name | |
Last name | Daisuke Shibata |
Heart life hospital
gastroenterological medicine
208 ijyu nakagusuku nakagami Okinawa Japan
098-895-3255
daisakimei@yahoo.co.jp
Heart life hospital
Okinawa prefecture
Local Government
NO
社会医療法人かりゆし会 ハートライフ病院(沖縄県)
2014 | Year | 10 | Month | 01 | Day |
Unpublished
No longer recruiting
2012 | Year | 09 | Month | 28 | Day |
2013 | Year | 01 | Month | 25 | Day |
2016 | Year | 01 | Month | 29 | Day |
2014 | Year | 09 | Month | 25 | Day |
2016 | Year | 10 | Month | 01 | Day |
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 |