Gene therapy breakthrough: one dose may help babies with rare muscle disease

NCT ID NCT03505099

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a single dose of Zolgensma gene therapy in 30 infants diagnosed with spinal muscular atrophy (SMA) before symptoms appeared. The goal was to see if the treatment helps them reach motor milestones like sitting or standing alone. The therapy delivers a working copy of the missing SMN gene to stop muscle weakness from progressing.

What this could mean

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

Active substance

onasemnogene abeparvovec (Zolgensma) gene therapy

What this could lead to

If successful, this one-time gene therapy could help infants with spinal muscular atrophy achieve key motor skills like sitting and standing, potentially preventing severe muscle weakness.

What could go wrong

This is a small, early-phase study (30 infants) and results may not apply to all SMA types. Long-term effects and risks, such as liver toxicity or immune reactions, are still being studied.

Disclaimer Read more

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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Conditions

The condition(s) this trial relates to.

spinal muscular atrophy spinal muscular atrophy, type 1 spinal muscular atrophy, type II

As listed by the trial registrant

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

Contacts and locations

Locations

  • Canada Childrens Hospital of Eastern Ontario

    Ottawa, Ontario, K1H8L1, Canada

  • Centre Hospitalier Régional Hôpital La Citadelle

    Liège, 4000, Belgium

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Medical Center Dallas

    Dallas, Texas, 75235, United States

  • Clinic for Special Children

    Strasburg, Pennsylvania, 17579, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London, WC1N 3JH, United Kingdom

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Hospital

    Orlando, Florida, 32827, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Sydney Children's Hospital

    Randwick, New South Wales, 2145, Australia

  • Tokyo Women's Medical

    Tokyo, Japan

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792, United States