decompensated liver cirrhosis
Conditions
Interventions
Sponsors
Taro Takami
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with decompensated liver cirrhosis with a Child-Pugh score of 7 or higher (Child-Pugh B) at two points separated by at least 90 days, in whom further improvement is not expected with current medical treatment. (2) Patients aged 20 to 75 years. (3) Patients from whom written consent for participation in this clinical study was obtained.
Exclusion criteria
Exclusion criteria: (1) Patients with a current history of malignant neoplasm with the exception of carcinoma in situ. (2) Patients with gastroesophageal varices at risk of rupture. (3) History of alcohol abuse within the last 6 months prior to acquiring a consent to study. (4) Patients with total bilirubin of 5.0mg/dL or higher (5) Patients with a hemoglobin <8 g/dL, a platelet count <50,000/uL, or a prothrombin time <40%. (6) Patients with renal insufficiency and a serum creatinine greater than or equal to 2 mg/dL. (7) Patients with a performance status of 3 or 4. (8) Patients who refuse to consent to allogeneic blood transfusion. (9) Patients for whom infection with syphilis, HIV, adult T-cell leukemia virus, parvovirus B19 cannot be ruled out (10) Women who are pregnant. (11) Patients for whom angiography cannot be carried out. (12) Patients with a current or previous severe allergic reaction to anesthesia. (13) Patients with a current or previous severe allergic reaction to a contrast agent. (14) Patients with a current or previous severe allergic reaction to beef, cow milk. (15) Patients who had an experience with other cell therapy or other clinical study of cell therapy. (16) Participated in a concurrent interventional study with the last intervention occurring within 6 months prior to acquiring a consent to study. (17) Any patient deemed unsuitable for study inclusion by their attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events with hepatic arterial infusion of cultured autologous bone marrow cells | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Child-Pugh score (2) Serum albumin levels (3) Serum fibrosis markers (4) Liver stiffness (5) Portal blood flow | — |
Countries
Japan
Contacts
Public ContactYoshio Marumoto
Yamaguchi University Hospital
Outcome results
None listed