How the immune system reacts to muscle gene therapy using AAV

Mechanism of immune response to muscle-directed AAV gene transfer

NIH-funded research Indiana University Indianapolis · NIH-11325270

They are figuring out how people's immune systems respond when AAV-based gene therapy is given to muscles, especially for conditions like Duchenne muscular dystrophy.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionIndiana University Indianapolis NIH-funded
Lab location1 site (Indianapolis, United States)
Project IDNIH-11325270 on NIH RePORTER

What this research studies

This project looks at how your immune system reacts when AAV gene therapy is given to muscles for conditions like Duchenne muscular dystrophy. Researchers will examine immune cells, antibodies, complement activation, and T cell responses using lab experiments and animal models that mimic human disease, including dogs with DMD. They will study why neutralizing antibodies form, why re-dosing often fails, and immune responses to gene-editing tools such as Cas9. The team plans to use these results to guide safer and more durable muscle-directed gene therapies.

Who could benefit from this research

Good fit: People with Duchenne muscular dystrophy or other severe muscle-wasting conditions who are considering, have received, or could donate samples for AAV-based gene therapies are the most relevant candidates.

Not a fit: People without muscle disease or those seeking immediate treatment are unlikely to gain direct clinical benefit from this mainly preclinical/translational research.

Why it matters

Potential benefit: If successful, this work could make AAV muscle gene therapies safer and longer-lasting and help enable repeat dosing when needed.

How similar studies have performed: Prior AAV gene-delivery efforts have achieved therapeutic gene expression in some cases, but immune responses such as neutralizing antibodies, T cell reactions, and complement activation have limited effectiveness and re-dosing, so this area is promising but still faces important challenges.

Where this research is happening

Indianapolis, 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.
Conditions Acid Maltase Deficiency DiseaseAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome Virus
Last reviewed 2026-06-13 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.