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One-Time gene therapy could change fabry disease treatment

NCT ID NCT04046224

First seen Apr 23, 2026 · Last updated Jun 23, 2026 · Updated 11 times

Summary

This trial tested a new gene therapy called ST-920 for Fabry disease, a rare genetic condition. The therapy uses a harmless virus to deliver a working gene that helps the body produce an enzyme it's missing. 36 adults with Fabry disease received a single intravenous dose and were monitored for a year to check safety and tolerability. The goal is to see if this one-time treatment can provide long-term benefits.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Lysosomal and Rare Disorders Research and Treatment Center (LDRTC)

    Fairfax, Virginia, 22030, United States

  • M.A.G.I.C. Clinic Ltd.

    Calgary, Alberta, T2E 7Z4, Canada

  • Mt. Sinai School of Medicine

    New York, New York, 10029, United States

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Royal Free Hospital

    London, United Kingdom

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • University Hospital of Würzburg

    Würzburg, Germany

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Germany

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • University of South Florida

    Tampa, Florida, 33620, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

ST-920 (a gene therapy using a modified virus to deliver a working copy of the alpha-galactosidase A gene)

What this could lead to

If successful, this could provide a long-term treatment option for Fabry disease, potentially reducing or eliminating the need for regular enzyme replacement therapy.

What could go wrong

This is an early-phase trial (Phase 1/2) with only 36 participants, so safety and effectiveness are not yet proven. Gene therapies can have unexpected side effects, and long-term benefits are uncertain.

Conditions

The condition(s) this trial relates to.

Fabry disease lysosomal storage disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.