Decompensated cirrhosis (Child-Pugh classification B) Decompensated cirrhosis
Conditions
Interventions
Harvesting liver tissue, and intraportal vein transplantation
Sponsors
Eguchi Susumu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included. 1) Males and females aged 20 to 80 years at the time of obtaining consent 2) Patients who have been diagnosed with cirrhosis by any of the following: - Patients with pathologically confirmed cirrhosis by liver biopsy - Patients with liver stiffness of 12.5 kPa or more on fibroscan at screening and fibrosis stage F4 (cirrhosis) 3) Patients with Child-Pugh scores in the range of 7 to 9 points (Child-Pugh classification B) at two points separated by more than 90 days 4) Patients with any of the following decompensated cirrhosis 1.Patients with decompensated cirrhosis caused by HCV or HBV - Patients with HCV decompensated cirrhosis who have hepatitis C and have achieved SVR for more than 12 months at the time of registration - Patients with HBV decompensated cirrhosis who are serum HBV-DNA positive or HBs antigen positive and have been receiving nucleotide analogues for more than 12 months 2. Patients with decompensated cirrhosis diagnosed with MASH 3. Patients with alcohol-related decompensated cirrhosis who have maintained complete alcohol abstinence for at least 6 months prior to providing informed consent 5) Patients with ECOG performance status of 2 or less 6) Patients who have given voluntary written consent to participate in this study 7) Patients for whom treatment through liver transplantation is difficult due to any of the following: - Patients who are unable to register for deceased donor liver transplantation due to age restrictions - Patients who have no available living donor candidates for living donor liver transplantation - Patients who are deemed ineligible for liver transplantation for medical or social reasons
Exclusion criteria
Exclusion criteria: Patients who meet the following conditions at the time of enrollment will not be enrolled in this clinical study. 1) Patients with alcohol-related liver disease who have consumed alcohol within 6 months prior to obtaining informed consent 2) Patients with portal vein thrombosis on contrast CT scan 3) Patients with a tendency to bleed, or patients who cannot discontinue anticoagulants 4) Patients with esophageal varices diagnosed as requiring treatment by endoscopic examination at screening 5) Patients with prominent collateral circulation (shunt formation) visible on imaging 6) Patients with liver cirrhosis caused by autoimmune diseases 7) Patients with moderate or greater amounts of ascites 8) Patients with or a history of primary liver cancer, or patients with hypovascular nodules showing low signal intensity in the hepatocellular phase on EOB-MRI examination at screening 9) Patients with current malignant neoplasms 10) Patients with eGFR of 30 mL/min/1.73m*2 or less on blood test at screening 11) Patients with total bilirubin (T-Bil) value of 5.0 mg/dL or more 12) Patients with confirmed infection with human immunodeficiency virus (HIV) or adult T-cell leukemia virus (HTLV-1) 13) Patients who have undergone solid organ transplantation, cell transplantation, or bone marrow transplantation. 14) Pregnant or breastfeeding women, women of childbearing potential who have had a positive pregnancy test, and patients who are unable to agree to use contraception from the time of obtaining consent until the end of observation. 15) Patients with psychiatric disorders that are deemed to affect obtaining consent. 16) Patients who are otherwise deemed inappropriate for participation in this study by the person in charge or the doctor in charge of regenerative medicine, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events and device malfunctions occurring from the time of laparoscopic partial hepatectomy for liver tissue procurement through 1 month after CLP-001 transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Adverse events and device malfunctions occurring from the time of laparoscopic partial hepatectomy for liver tissue procurement through 12 month after CLP-001 transplantation. Efficacy Change in Child-Pugh score Proportion of patients with improvement in Child-Pugh score Proportion of patients with improvement in Child-Pugh class Change in ALBI grade Exploratory Endpoints Efficacy for overall severity of cirrhosis MELD score Efficacy for hepatic fibrosis Serum fibrosis markers: P-3-P, Hyaluronic acid, Type 4 Collagen 7S, M2BPGi, Pro-C3 Liver stiffness measurement: ultrasound elastography Fibrosis index: Fib-4 Efficacy for hepatic inflammation Clinical laboratory parameters: ALP, ALT, AST Efficacy for liver function Clinical laboratory parameters: Albumin (ALB), Prothrombin Time (PT), Total Bilirubin (T-Bil), Ammonia, Cholinesterase, Antithrombin 3 Efficacy for clinical manifestations of cirrhosis Neuropsychiatric assessment: hepatic encephalopathy Abdominal ultrasound: ascites Body weight | — |
Countries
Japan
Contacts
Public ContactMayumi Ohira
Nagasaki University Hospital
Outcome results
None listed