Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
LyGenesis, Inc.
Study ID
NCT04496479
Phase
PHASE2
Status
Recruiting
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Conditions

  • End Stage Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • LYG-LIV0001 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Mar 11, 2022
Status verified
Aug 2025
Primary completion
Aug 20, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LYG-LIV0001
    Open label group of subjects with end stage liver disease receiving increasing doses of the experimental therapy.

Primary Outcome Measure

Dosage Selection [ Time Frame: Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111-
Houston Methodist HospitalHoustonTexas77030
Constance Mobley, MD

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By research site
Tufts Medical Center· Boston, MAHouston Methodist Hospital· Houston, TX

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