Gene therapy to replace the missing GALT enzyme in classic galactosemia

Gene Therapy in a GALT-null Rat Model of Classic Galactosemia

['FUNDING_OTHER'] · EMORY UNIVERSITY · NIH-11179344

Testing a one-time gene therapy that delivers a working GALT enzyme to try to prevent the long-term problems of classic galactosemia in people born without the enzyme.

Quick facts

Phase['FUNDING_OTHER']
Study typeNih_funding
SexAll
SponsorEMORY UNIVERSITY (nih funded)
Locations1 site (ATLANTA, UNITED STATES)
Trial IDNIH-11179344 on ClinicalTrials.gov

What this research studies

This project uses a viral carrier (AAV9) to deliver a working copy of the GALT gene into a rat model that lacks the enzyme, to see if restoring GALT prevents the kinds of speech, learning, movement, growth, and reproductive problems that people with classic galactosemia often face. Researchers will give the gene therapy to GALT-null rats and follow them over time to measure levels of galactose and its metabolites (galactose-1P and galactitol) and look for improvements in growth and neurological and reproductive outcomes. The work is preclinical and done at Emory University using established animal models to learn whether this approach could work safely and broadly. Findings will inform whether a similar gene therapy could move toward human clinical trials in the future.

Who could benefit from this research

Good fit: Ideal future candidates would be people with classic galactosemia caused by GALT deficiency, especially infants identified by newborn screening who might benefit most from early correction of the enzyme defect.

Not a fit: People whose condition is not caused by GALT deficiency, those with irreversible late-stage damage, or individuals with unrelated health problems may not benefit from this specific therapy.

Why it matters

Potential benefit: If successful, this approach could lead to a one-time treatment that reduces harmful galactose metabolites and prevents lifelong cognitive, motor, growth, and reproductive complications of classic galactosemia.

How similar studies have performed: AAV-based gene therapies have shown success for other inherited metabolic diseases in animals and some human trials, but applying AAV9 GALT replacement specifically to galactosemia is novel and mostly untested in humans.

Where this research is happening

ATLANTA, 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 →

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.