Why AAV gene therapy gets turned off in human liver cells

Dissecting AAV silencing in humanized mice

['FUNDING_R01'] · DUKE UNIVERSITY · NIH-11258501

This project looks for ways to stop AAV-based gene treatments from being switched off in human liver cells so people with liver genetic disorders might get longer-lasting benefit.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorDUKE UNIVERSITY (nih funded)
Locations1 site (DURHAM, UNITED STATES)
Trial IDNIH-11258501 on ClinicalTrials.gov

What this research studies

Researchers use mice that carry human liver cells so they can watch how AAV-delivered genes behave in real human hepatocytes inside a living body. They will study a cellular silencing system called the Human Silencing Hub (HUSH) to learn how it may turn off AAV transgenes, including experiments using liver cells from patients with methylmalonic acidemia as a proof-of-concept. Finally, the team will test different AAV vector designs and drugs to try to prevent or reverse silencing and restore gene expression.

Who could benefit from this research

Good fit: Ideal candidates would be people with genetic liver disorders (for example methylmalonic acidemia) who can provide liver-derived samples or otherwise collaborate with the research team.

Not a fit: People whose conditions are unrelated to liver-directed gene therapy or who cannot provide samples are unlikely to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, this work could make liver-directed AAV gene therapies work longer and more reliably for people with genetic liver diseases.

How similar studies have performed: AAV liver gene therapies have shown success in some disorders, but transgene silencing is a known hurdle and targeting the HUSH pathway represents a newer, less-tested approach.

Where this research is happening

DURHAM, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Conditions: Acid Maltase Deficiency Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.