← Back to Search

Hepatocyte Transplantation

Liver Cell Transplant for End-Stage Liver Disease

Phase 2
Recruiting
Research Sponsored by LyGenesis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV RNA
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
Must not have
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 previously treated neoplastic disease with less than a 2-year cancer free period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to transplant liver cells into people with end-stage liver disease. The goal is to see if it is safe, tolerated, and effective.

Who is the study for?
Adults aged 18-70 with end-stage liver disease (ESLD) from various causes and a MELD-Na score of >10 to <25. Must have stable control of portal hypertension, BMI <35, no severe infections or recent cancers, not pregnant or breastfeeding, and willing to avoid alcohol. Those with HBV/HCV must meet specific treatment criteria.
What is being tested?
The trial is testing the safety and effectiveness of transplanting hepatocytes (liver cells) into lymph nodes near the duodenum using an endoscopic ultrasound in patients with ESLD. It's a Phase 2a dose escalation study.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with endoscopic procedures such as infection, bleeding, pain at the injection site, pancreatitis, and adverse reactions to transplanted cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been treated for hepatitis C and have had no virus detected in my blood for 24 weeks.
Select...
I have severe liver disease with a specific severity score between 10 and 25.
Select...
My kidney function is reduced, with an eGFR below 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have alcoholic liver disease and haven't abstained from alcohol for 6 months despite rehab.
Select...
I had cancer before and have been cancer-free for less than 2 years.
Select...
My blood urea nitrogen (BUN) level is 80 mg/dL or higher.
Select...
I am currently hospitalized for a severe infection needing long-term antibiotics.
Select...
I have severe esophageal varices and must continuously use Propanolol.
Select...
My kidney function is normal or only mildly reduced.
Select...
I have a liver tumor, either hepatocellular carcinoma or cholangiocarcinoma.
Select...
I need treatment for cancer that has spread outside my liver.
Select...
My liver disease is severe, classified as Child-Pugh C.
Select...
I have severe fluid buildup in my abdomen not responding to water pills, needing frequent drainage.
Select...
My blood pressure is not higher than 110 mm Hg diastolic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dosage Selection
Efficacy of Engraftment of Hepatocytes in to Lymph Nodes
Safety of Engraftment of Hepatocytes in to Lymph Nodes
Secondary study objectives
Effectiveness of Selected Treatment to Modify the Liver Function Panel
Other study objectives
Change from Baseline in Ascities/Sarcopenia
Change from Baseline in Fatigue
Change from Baseline in Hepatic Function
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LYG-LIV0001Experimental Treatment1 Intervention
Open label group of subjects with end stage liver disease receiving increasing doses of the experimental therapy.

Find a Location

Who is running the clinical trial?

LyGenesis, Inc.Lead Sponsor
Paulo Fontes, MDStudy ChairLyGenesis, Inc.

Media Library

LYG-LIV0001 (Hepatocyte Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT04496479 — Phase 2
Liver Disease Research Study Groups: LYG-LIV0001
Liver Disease Clinical Trial 2023: LYG-LIV0001 Highlights & Side Effects. Trial Name: NCT04496479 — Phase 2
LYG-LIV0001 (Hepatocyte Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04496479 — Phase 2
~4 spots leftby Feb 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top