Cirrhosis caused by hepatitis C virus Type C cirrhosis
Conditions
Interventions
Protocol treatment is to consist of the following two groups.
Cell Infusion group: Cell Infusion treatment is to be provided within one week of administration, and the final evaluation is to be carri
Sponsors
Takami Taro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Cirrhosis caused by hepatitis C virus (2)Cases of patients with a Child-Pugh score of 7 or higher (Child-Pugh B) at two time points separated by 90 days or longer, and those for whom it is not expected that symptoms will improve with current internal medicine therapy. (3)Cases of patients aged 20 to 75 years, inclusive (4)Cases from whom it is possible to obtain informed consent, and from whom consent to participate in the study is obtained
Exclusion criteria
Exclusion criteria: (1)Cases of cirrhosis due to causes other than hepatitis C virus, or cases of hepatitis due to unknown causes (2)Cases complicated with malignant neoplasms, or cases with a past history of them (3)Cases of patients who have esophageal varices or gastric varices with a risk of rupture (4)Cases of patients conjugated with renal dysfunction with serum creatinine values of 2 mg/ dL or greater (5)Cases of patients whose hemoglobin level is less than 8 g/dL, platelet count less than 50,000 /uL, or PT less than 40% (6)Cases with total bilirubin of 3.0mg/dL or higher (7)Cases with performance status of 3 or 4 (8)Cases of patients from whom consent cannot be obtained for allogeneic blood transfusion (9)Cases for whom infection with syphilis, hepatitis B virus, HIV, adult T-cell leukemia virus, parvovirus B19 cannot be ruled out (10)Pregnant women (11)Cases of patients for whom the investigator determined that general anesthesia is inappropriate (12)Cases with severe allergies to contrast agents, or those with a past history of severe allergies to contrast agents (13)Cases of patients for whom the Investigator determined that participation is inappropriate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of cases in whom the Child-Pugh score improved by one point or more by the time of Week 24 following infusion for the Cell Infusion group, and at the time of Week 24 after registration for the Standard Treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following indices are to be the secondary endpoints at the time of Week 24 after cell infusion for the Cell Infusion group, and at Week 24 after registration for the Standard Treatment group. (1)Change in efficacy maintenance rate (definition of efficacy maintenance: no deterioration in Child-Pugh score) (2)Changes in albumin values (3)Changes in serum fibrosis marker values (4)Changes in the volume of ascitic fluid*1 (5)Changes in the improvement rate and the disappearance rate*2 of lower limb edema (6)Changes in subjective symptoms (7)Adverse events | — |
Countries
Japan
Contacts
Public ContactYoshio Marumoto
Yamaguchi University Hospital Center of Clinical Research
Outcome results
None listed