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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been treated for hepatitis C and have had no virus detected in my blood for 24 weeks.
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I have severe liver disease with a specific severity score between 10 and 25.
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My kidney function is reduced, with an eGFR below 45.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dosage Selection
Efficacy of Engraftment of Hepatocytes in to Lymph Nodes
Safety of Engraftment of Hepatocytes in to Lymph Nodes
Secondary outcome measures
Effectiveness of Selected Treatment to Modify the Liver Function Panel
Other outcome measures
Change from Baseline in Ascities/Sarcopenia
Change from Baseline in Fatigue
Change from Baseline in Hepatic Function
+4 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have alcoholic liver disease and haven't abstained from alcohol for 6 months despite rehab.I am between 18 and 70 years old.I have heart or lung conditions that prevent me from having standard liver transplant.I had cancer before and have been cancer-free for less than 2 years.I have hepatitis B, am on stable treatment for 6 months, and my HBV DNA is below 500 c/mL.I or my partner will use effective birth control during and for 1 month after the study.My high blood pressure in the liver's veins is under control with medication or procedures.I have severe liver disease with a specific severity score between 10 and 25.My blood urea nitrogen (BUN) level is 80 mg/dL or higher.I am currently hospitalized for a severe infection needing long-term antibiotics.You have mental health or social problems that might make it difficult for you to follow the study guidelines.I have been treated for hepatitis C and have had no virus detected in my blood for 24 weeks.I have severe esophageal varices and must continuously use Propanolol.I had a TIPS procedure for portal hypertension over a month ago and have no serious complications.My kidney function is normal or only mildly reduced.I have a liver tumor, either hepatocellular carcinoma or cholangiocarcinoma.I need treatment for cancer that has spread outside my liver.My liver disease is severe, classified as Child-Pugh C.I have severe fluid buildup in my abdomen not responding to water pills, needing frequent drainage.My blood pressure is not higher than 110 mm Hg diastolic.My kidney function is reduced, with an eGFR below 45.You have a known allergy to human serum albumin.
Research Study Groups:
This trial has the following groups:- Group 1: LYG-LIV0001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does LYG-LIV0001 pose a risk to human health?
"Our team at Power assigned LYG-LIV0001 a score of 2 on the safety scale due to its status as a Phase 2 trial, which means there is some evidence supporting security but none indicating effectiveness."
Answered by AI
Are there any restrictions as to who can partake in this research trial?
"This clinical trial seeks to include 12 patients who suffer from chronic liver failure, ranging in age from 18 through 70."
Answered by AI
Is the cut-off age for eligibility in this study 80 years or younger?
"The lower age limit for this study is 18 and the upper age threshold is 70, in accordance with the trial's entry qualifications."
Answered by AI
Is recruitment for this clinical trial currently underway?
"According to the records hosted on clinicaltrials.gov, this particular medical trial is not enrolling patients at present. The study was initially posted in March 11th 2022 and its information was most recently updated on May 24th 2022. Despite this trial's closure for recruitment, there are still 275 other studies inviting participants."
Answered by AI
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