Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
| Condition(s) | End Stage Liver Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease. |
| Who can participate | Inclusion Criteria: 1. Have read, understood, and signed the informed consent form (ICF). 2. Adults of either gender and ages 18 to 70 years old with a diagnosis of ESLD due to alcohol, chronic hepatitis B virus (HBV) and/or 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 and \<25 at screening. 3. Subjects must have a body mass index (BMI) \<35. 4. Subjects with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV ribonucleic acid (RNA). 5. Subjects with HBV must be on stable therap |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | LyGenesis, Inc. |
| Locations | Boston, Massachusetts, United States; Houston, Texas, United States |
| Start date | 2022-03-11 |
| NCT ID | NCT04496479 |
| Official listing | https://clinicaltrials.gov/study/NCT04496479 |