NCT04496479

Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: LyGenesis, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.

Detailed description

This safety, tolerability, and efficacy study includes an open-label dose-escalation phase for up to 12 subjects with end-stage liver disease (ESLD).

Conditions

• End Stage Liver Disease

Interventions

Type	Name	Description
BIOLOGICAL	LYG-LIV0001	Allogenic hepatocytes suspended in a buffered cell preservation solution with increasing number of lymph nodes being transplanted for the dose escalation. Subjects will also receive immune suppression, including tacrolimus capsules to follow the dose prescribed by the investigator as well as a short course of prednisone.

Timeline

• Start date: 2022-03-11
• Primary completion: 2027-08-20
• Completion: 2027-12-30
• First posted: 2020-08-03
• Last updated: 2025-08-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study