Actively Recruiting
A Phase 2a, Open Label, Dose Escalation Study for Safety, Tolerability, and Efficacy of Hepatocyte Transplantation Into Periduodenal Lymph Nodes Among Subjects With End-Stage Liver Disease
Led by LyGenesis, Inc. · Updated on 2025-08-08
12
Participants Needed
2
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of transplanting hepatocytes into lymph nodes for people with end-stage liver disease (ESLD). This Phase 2a open-label dose escalation study aims to find the right dose and assess how well the transplanted cells engraft in subjects with ESLD caused by various liver conditions. The study includes up to 12 participants and is sponsored by LyGenesis, Inc. Participants receive allogenic hepatocytes suspended in a preservation solution, which are transplanted into periduodenal lymph nodes using endoscopic ultrasound. The study uses a dose-escalation approach, gradually increasing the number of lymph nodes treated. Subjects also receive immune-suppressing medications including tacrolimus capsules and a short course of prednisone to support the transplant. During the study, participants are monitored closely for safety and how well the hepatocytes engraft at 12 weeks, along with liver function tests assessed up to 52 weeks. Researchers evaluate dosage selection, safety, and efficacy at week 12, and the treatment's effect on liver function over one year. Participants must comply with study requirements and avoid alcohol during the trial, which lasts over a year including follow-up visits and assessments.
CONDITIONS
Brief Title
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years with end-stage liver disease due to specific liver conditions
- MELD-Na score greater than 10 and less than 25 at screening
- Body mass index (BMI) less than 35
- Treated and cleared hepatitis C virus infection for at least 24 weeks if applicable
- Stable hepatitis B virus therapy with low viral load if applicable
- Women of childbearing potential or partners must use effective contraception during and for 1 month after the study
- Stable control of portal hypertension and upper gastrointestinal bleeding
- Stable condition after TIPS procedure if applicable
- Blood urea nitrogen (BUN) below 80 mg/dL
- Estimated glomerular filtration rate (eGFR) at least 45 mL/min/1.73 m2
- Agree to avoid alcohol during the study
- Willing and able to follow all study requirements
You will not qualify if you...
- Primary liver cancers such as hepatocellular carcinoma or cholangiocarcinoma
- Active or uncontrolled severe infections needing hospitalization
- Severe blood clotting problems (INR over 2 or platelet count below 50,000/µL)
- Psychiatric or social issues that affect compliance
- Other cancers requiring active treatment or recent cancer history under 2 years
- Pregnant or breastfeeding women
- Allergy to human serum albumin
- Uncontrolled high blood pressure
- Recurrent severe fluid buildup in abdomen needing frequent drainage
- Active alcoholic liver disease without 6 months abstinence and rehab
- Severe esophageal varices requiring continuous medication that cannot be stopped
- Child-Turcotte-Pugh Class C liver disease
- Receiving or planning to receive other investigational treatments or devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive allogenic hepatocyte transplantation into periduodenal lymph nodes along with immune suppression medication including tacrolimus and a short course of prednisone.
Multiple visits during the treatment period as prescribed by the investigator
Duration - Up to 40 weeks after treatment
Participants are monitored for safety, engraftment efficacy, and liver function modification after the treatment period.
Periodic visits up to Week 52
Trial Site Locations
Total: 2 locations
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Withdrawn
2
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paulo Fontes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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