Allogenic Hepatocyte Transplantation for End-Stage Liver Disease
This study is testing a treatment called LYG-LIV0001 for people with end-stage liver disease. LYG-LIV0001 involves transplanting healthy liver cells (allogenic hepatocytes) into lymph nodes, which are small glands that are part of your immune system. Participants will also receive medicine to prevent their body from rejecting the new cells. The study is looking at how safe this treatment is, if the transplanted cells successfully grow in the lymph nodes, and what the best dose is. To join, you must be between 18 and 70 years old and have end-stage liver disease caused by conditions like alcohol use, hepatitis B or C, or autoimmune hepatitis. The study is currently unclear on its recruitment status and plans to enroll up to 12 participants.
- Study design
- This is a Phase 2a study that is open-label, meaning both you and the study team will know what treatment you are receiving. It is a dose-escalation study, meaning different participants will receive different doses of the treatment. Up to 12 participants are planned to be enrolled.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes for safety, engraftment, and dosage selection will be measured at Week 12 after the treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
At a glance
Conditions
NCT04496479
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Houston Methodist Hospital
Houston, Texasno site contact published
Recruiting
Tufts Medical Center
Boston, Massachusettsno site contact published
Withdrawn
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Paulo Fontes, MD · STUDY_CHAIR · LyGenesis, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Dosage SelectionWeek 12
The primary objective of the dose escalation is to confirm the optimal dose of transplanted hepatocytes to safely achieve adequate allogeneic hepatocyte (AH) engraftment
- Safety of Engraftment of Hepatocytes in to Lymph NodesWeek 12
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
- Efficacy of Engraftment of Hepatocytes in to Lymph NodesWeek 12
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