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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

LYG-LIV0001
Biological/Vaccine
Allogenic hepatocytes suspended in a buffered cell preservation solution with increasing number of lymph nodes being transplanted for the dose escalation. Subjects will also receive immune suppression, including tacrolimus capsules to follow the dose prescribed by the investigator as well as a short course of prednisone.

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: LYG-LIV0001Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Dosage Selection

The primary objective of the dose escalation is to confirm the optimal dose of transplanted hepatocytes to safely achieve adequate allogeneic hepatocyte (AH) engraftment

Time frame

Week 12

Safety of Engraftment of Hepatocytes in to Lymph Nodes

The primary safety objective of the dose escalation is to determine whether AH engraftments into the periduodenal lymph nodes in subjects with end-stage liver disease is safe as determined by the number/severity of adverse events

Time frame

Week 12

Efficacy of Engraftment of Hepatocytes in to Lymph Nodes

The primary efficacy objective of the dose escalation is to determine whether AH engraftments into the periduodenal lymph nodes in subjects with end-stage liver disease is efficacious in addressing some of the signs and symptoms of end-stage liver disease

Time frame

Week 12

Secondary outcomes

Effectiveness of Selected Treatment to Modify the Liver Function Panel

Evaluate the effectiveness of hepatocyte transplants in modifying the liver function panel (total serum bilirubin, ammonia, prothrombin time, international normalized ratio, sodium, blood urea nitrogen, and creatinine) as measured through changes in laboratory biomarkers caused by end-stage liver disease

Time frame

Week 52

Other outcomes

Change from Baseline in Ascities/Sarcopenia

Changes from baseline in ascities/sarcopenia as measured by Computerized Tomography (CT) Scan

Time frame

Week 52

Change from Baseline in Lean Body Mass

Changes from baseline in lean body mass as measured by Skinfold Testing, Bioelectrical Impedance Analysis, or DexaScan

Time frame

Week 52

Change from Baseline in Liver Reserve

Changes from baseline in liver reserve as measured through the Disease Severity Index

Time frame

Week 52

Change from Baseline in Hepatic Function

Changes from baseline in hepatic function as measured through the HepQuant SHUNT Testing (assessing liver function in chronic liver disease)

Time frame

Week 52

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LyGenesis, Inc.

Lead sponsor

Source ClinicalTrials.gov

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