LYG-LIV-001 tests whether transplanted liver cells can grow useful liver tissue inside a person's lymph nodes. LyGenesis began dosing participants with end-stage liver disease in 2024.
The company's first cohort review supported continuation. The release did not provide the patient outcome dataset needed to judge clinical benefit.
The product code is LYG-LIV-001; LYG-LIV-02-001 identifies the protocol, and NCT04496479 is the registry entry.
- Prepare donor hepatocytesThe human programme uses cells from another person.
- Engraft in lymph nodesThe proposed liver tissue is ectopic.
- Measure functional supportFollow compatibility, tissue formation and liver function.
The native liver remains present; the diagram does not depict whole-organ replacement. Sources for this account.
The mechanism
Researchers isolate hepatocytes from donated livers and prepare the cells for transplantation. They use endoscopic ultrasound to place the cells into upper abdominal lymph nodes. The programme uses allogeneic cells, which come from another person.
The proposed tissue is ectopic: it grows outside the native liver. The lymph node supplies an environment in which the cells can engraft and expand. The objective is auxiliary tissue that supports liver function while the damaged native liver remains present.
A 2020 swine study examined transplanted hepatocytes after surgically induced liver injury. Researchers found engraftment and organised liver-like tissue within lymph nodes after 30 to 60 days. That work used autologous cells taken from the same animals, whereas the human programme uses donor cells.
Cell survival in a pig experiment answers part of the engineering problem. The human study also has to address donor-cell compatibility, the amount of functional tissue formed and the course of severe chronic liver disease.
Human evidence
The disclosed Phase 2a design is an open-label dose-escalation study with a planned 12 participants in three cohorts of four. Participants are followed for a year to examine safety, tolerability and early efficacy.
The first cohort's review supported escalation, according to the company. No randomised control group is described in that design. Patient-level changes, concurrent care and the expected disease course would therefore need careful examination in any eventual results report.
The liver findings do not establish outcomes for LyGenesis's proposed thymus, pancreas or kidney programmes. Each requires its own experiments.
Studies and experimental evidence
NCT04496479 / LYG-LIV-02-001
- Design
- Open-label Phase 2a dose escalation
- Population or model
- People with end-stage liver disease
- Sample size
- 12 planned; first cohort of 4 reviewed in March 2025
- Comparison
- No randomised comparator in disclosed design
- Duration
- One-year follow-up per participant
- Outcome
- Safety, tolerability and early efficacy
Company reports safety-board recommendation to continue and escalate
Detailed outcome dataset not released in checked announcement
Funding and interests: LyGenesis sponsored
Development of ectopic livers in swine
- Design
- Prospective transplantation experiments
- Population or model
- Swine with induced subacute liver injury
- Sample size
- Multiple experiments; no combined sample stated here
- Comparison
- Native tissue and experimental model comparisons
- Duration
- 30–60 days
- Outcome
- Engraftment and histological organisation
Hepatocytes formed organised ectopic liver tissue
Autologous animal cells; induced injury differs from chronic human disease
Funding and interests: Company-affiliated authors; full paper disclosures apply
Development history
Swine evidence published online
The paper described ectopic liver tissue after hepatocyte transplantation.
First participant reported dosed
LyGenesis announced the start of human dosing.
First cohort passed safety review
Company reported the board's recommendation to continue and escalate.
Unresolved questions
- How much functional liver tissue forms in each participant, and how is it measured?
- Can the ectopic tissue improve clinically relevant outcomes beyond laboratory changes?
- How durable is the transplanted tissue over longer follow-up?
- What immune-management burden accompanies donor hepatocytes?
- What study design would separate the cell therapy's effect from the course of advanced liver disease?
The reported next step was a further cohort after the safety review. Completion was not verified here. The registry history and detailed results for all enrolled participants are needed to establish what followed.
Sources
- Paper · 1 Oct 2020Development of Ectopic Livers by Hepatocyte Transplantation Into Swine Lymph Nodes
Online publication date; animal mechanism and histology.
Checked 4 Oct 2026 - Company disclosure · 2 Apr 2024LyGenesis announces first patient dosed
First human dosing and disclosed trial plan.
Checked 4 Oct 2026 - Company disclosure · 4 Mar 2025Safety board approves trial continuation and escalation
First four participants reviewed; no full efficacy dataset.
Checked 4 Oct 2026 - Trial registry · UndatedStudy record NCT04496479
Trial identifier. Design and development details above are attributed to the dated sponsor disclosures; a current detailed registry status was not established.
Checked 4 Oct 2026
Dr T Smith, organic chemist and science educator. Review date: 4 Oct 2026. Report a correction.