Cirrhosis of liver caused by lifestyle related disease(Including NASH)
Conditions
Interventions
One'
s own autologous bone marrow cell transplantation
Sponsors
Heart life hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactDaisuke Shibata
Heart life hospital gastroenterological medicine
Outcome results
None listed