Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes

This is an interventional treatment trial for End Stage Liver Disease focused on measuring Allogeneic, Organogenesis, Hepatocyte, Transplantation, Liver Disease Read More

Inclusion Criteria:

• Adults of either gender and ages 18 to 70 years old
• Subjects must have a diagnosis of end-stage liver disease (ESLD) due to alcohol, chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, autoimmune hepatitis, primary sclerosis cholangitis, primary biliary cirrhosis (cholangitis), cirrhosis as the result of Wilson disease, hemochromatosis, sarcoidosis and alpha 1 antitrypsin deficiency, cryptogenic cirrhosis and nonalcoholic steatohepatitis cirrhosis with a MELD-Na score >10 to <25 at screening.
• Subjects have a Body Mass Index (BMI) <35.
• Subjects with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV RNA.
• Subjects with HBV must be on stable therapy for 6 months and have HBV DNA <500 c/mL.
• Women of childbearing potential (WOCBP) or sexual partners of male subjects who are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 1 month after the last study visit. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
• Subject must have stable control of portal hypertension and upper gastrointestinal bleeding with medical therapy and/or endoscopic therapy.
• If the subject has undergone a transjugular intrahepatic portosystemic shunt (TIPS) procedure for the clinical management of portal hypertension, they must be stable for at least 1 month after the successful TIPS procedure, and not experiencing serious complications from the TIPS procedure itself (e.g., infection and intractable hepatic encephalopathy).
• Subject must have serum BUN <80 mg/dL.
• Subject must have a eGFR <45 mL/min/1.73m2.
• Subject may have had current and/or previous cardiopulmonary diseases precluding standard liver transplantation (e.g., coronary artery disease, portopulmonary hypertension, moderate chronic obstructive pulmonary disease).
• Subject must agrees to avoid alcohol consumption during the study.

Exclusion Criteria:

• Subject has primary hepatic neoplasms (hepatocellular carcinoma and cholangiocarcinoma).
• Subject has active and/or uncontrolled severe infections requiring hospitalization and prolonged antimicrobial therapy.
• Subject has renal failure with BUN >= 80 mg/dL.
• Subject has a eGFR >= 45 mL/min/1.73m2.
• Subject has severe coagulopathy (INR >2, and/or platelet count <50,000/μL).
• Subject has psychiatric and/or social issues that could lead to noncompliance.
• Subject has an extrahepatic neoplastic disease requiring active chemotherapy, immunotherapy, and/or surgical resection.
• Subject has previously treated neoplastic disease with less than a 2-year cancer free period.
• Subject is pregnant or lactating.
• Subject has known hypersensitivity to human serum albumin.
• Subjects with uncontrolled hypertension (defined as a diastolic blood pressure of 110 mm Hg or higher).
• Subject has recurrent/intractable ascites refractory to diuretics and requiring periodic large volume paracentesis.
• Subject has primary alcoholic liver disease and has not demonstrated abstinence for at least 6 months while attending mandatory rehab programs (e.g., AA) and psychotherapy.
• Subject has grade 3 esophageal varcies requiring the continuous use of Propanolol and cannot afford to have this medication withheld and/or discontinued.
• Subject has a Child-Turcotte-Pugh (CTP) Score of C.
• Subject is receiving or plans to receive treatment with another investigational product or device.