Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
ConditionEnd Stage Liver Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLyGenesis, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Have read, understood, and signed the informed consent form (ICF).
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.
Subjects must have a body mass index (BMI) <35.
Subjects with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV ribonucleic acid (RNA).
Disqualifiers
Has primary hepatic neoplasms (hepatocellular carcinoma and cholangiocarcinoma).
Has active and/or uncontrolled severe infections requiring hospitalization and prolonged antimicrobial therapy.
Has severe coagulopathy (international normalized ratio [INR] >2, and/or platelet count <50,000/μL).
Has psychiatric and/or social issues that could lead to noncompliance.
Trial design
Treatments tested in this trial
- LYG-LIV0001
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov