LYG-LIV-001 ectopic liver by LyGenesis: status and timeline

LYG-LIV-001 ectopic liver

Give people with failing livers extra liver function without a transplant. Up to half of end-stage patients cannot get a new liver; growing ectopic liver in lymph nodes could help them and stretch each donated organ to dozens of people.

PilotStage 3 of 5

Phase 2a dose escalation: cohort 1 (4 patients) cleared; higher doses across more lymph nodes next.

Updated 10d agoChecked 11 Oct0 updates this week

Milestones

Next · Cohort 2: 150M cells across 3 lymph nodes

Ectopic liver rescues pigs and dogs with liver failureDoneComplete.
First patient dosed in Phase 2a (Houston Methodist)Apr 2024Complete.
DSMB clears cohort 1 (4 patients) to dose-escalateMar 2025Complete.
Cohort 2: 150M cells across 3 lymph nodesNowCurrent milestone.
Cohort 3: 250M cells across up to 5 lymph nodesNot yet reached.

Most important updates

Current obstacles

Efficacy still unproven in peopleOnly first-cohort safety has been reported; whether ectopic liver grows and measurably improves function in humans awaits higher-dose cohorts.
Supply of donor cellsFresh cells depend on unmatched livers becoming available; the company is building cell cryopreservation to bank and ship them.

Physics limits

Lymph nodes are smallOne node holds a limited number of cells, so the top dose spreads 250M cells over up to five nodes; small animals grew ectopic liver up to 70% of native volume, but human nodes may differ.

How it works

4 parts

Cells from unused livers

Donor livers that missed a match

Hepatocytes (the liver's working cells) are isolated to clinical grade from donated livers that missed a transplant match. They are not genetically engineered.

Injection into nodes

Endoscope through the stomach wall

A doctor guides a needle by ultrasound through an endoscope into lymph nodes beside the duodenum, near the liver, in a roughly 10-minute outpatient procedure.

Growth signals

The sick liver tells the new one to grow

Nodes near the liver are bathed in growth signals released by the diseased organ, which drive the injected cells to multiply into ectopic liver tissue.

Support, not replace

A 10–20% boost may be enough

The new tissue does not replace the native liver; the company estimates that adding 10–20% of liver function could relieve many symptoms and buy time.

Spec sheet

Spec	LYG-LIV-001 ectopic liver
Phase 2a enrollment (planned)	12 patients, cohorts of 4^R (reported)
Cohort 1 dose	50M hepatocytes, 1 lymph node^R (reported)
Top planned dose	250M hepatocytes, up to 5 nodes^R (reported)
Procedure	Endoscopic ultrasound, ~10 min, light sedation^R (reported)
Patients per donated liver	50+ (company estimate)^R (reported)
Follow-up per patient	1 year^R (reported)

^R reported by the company

Update log

3 updates

About LyGenesis

The team behind LYG-LIV-001 ectopic liver

LyGenesis

Ectopic liver in lymph nodes, organ regeneration

Pittsburgh biotech that grows new organ tissue inside a patient's own lymph nodes. Its lead therapy injects donor liver cells into lymph nodes to grow a second, small liver in people with end-stage liver disease.

Uses lymph nodes as living bioreactors: donor cells injected there grow into working ectopic liver, without major surgery.
Phase 2a in end-stage liver disease at Houston Methodist; first cohort cleared for dose escalation in March 2025.
Same idea in preclinical work for thymus (immune aging), pancreatic islets and kidney.

lygenesis.com (opens lygenesis.com)Company profile →

Headquarters: United States
Status: Private
Valuation: private
Works in: LongevityReplacement & regenerationBiotech
Coverage: 1 program · 3 updateslatest 10d agochecked 11 Oct
Partners: Houston Methodist (opens biospace.com)iTolerance
Investors: JuvenescencePrime Movers Lab
People: Michael HuffordCo-founder and Chief Executive OfficerEric LagasseChief Scientific Officer

Spec

LYG-LIV-001 ectopic liver

Phase 2a enrollment (planned)

12 patients, cohorts of 4^R (reported)

Cohort 1 dose

50M hepatocytes, 1 lymph node^R (reported)

Top planned dose

250M hepatocytes, up to 5 nodes^R (reported)

Procedure

Endoscopic ultrasound, ~10 min, light sedation^R (reported)

Patients per donated liver

50+ (company estimate)^R (reported)

Follow-up per patient

1 year^R (reported)

LYG-LIV-001 ectopic liver

Milestones

Most important updates

Current obstacles

Physics limits

How it works

Donor livers that missed a match

Endoscope through the stomach wall

The sick liver tells the new one to grow

A 10–20% boost may be enough

Spec sheet

Update log

Thu 1 Oct

Tue 4 Mar 2025

Tue 2 Apr 2024

About LyGenesis

Current obstacles

Physics limits

How it works

Donor livers that missed a match

Endoscope through the stomach wall

The sick liver tells the new one to grow

A 10–20% boost may be enough

Spec sheet

Update log

Thu 1 Oct

Tue 4 Mar 2025

Tue 2 Apr 2024

About LyGenesis