One-Time gene therapy helps babies with deadly muscle disease sit and breathe on their own

NCT ID NCT03306277

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial tested a one-time gene therapy called Zolgensma in 22 infants under 6 months old with spinal muscular atrophy (SMA) type 1, a severe muscle-weakening disease. The treatment delivers a working copy of the missing SMN gene via an IV infusion. The main goals were to see if babies could sit independently for at least 30 seconds and survive without permanent breathing support.

What this could mean

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

Active substance

Zolgensma (onasemnogene abeparvovec-xioi), a one-time gene replacement therapy given by IV infusion

What this could lead to

If successful, this could provide a one-time treatment that helps infants with SMA type 1 sit independently and avoid the need for permanent breathing support.

What could go wrong

This is a small, single-arm trial with no comparison group, so results may not apply to all patients. Gene therapy carries risks like liver injury or immune reactions, and long-term effects are still unknown.

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.

proximal spinal muscular atrophy spinal muscular atrophy spinal muscular atrophy, type 1

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ann and Robert H Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Columbia University

    New York, New York, 10032, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Duke University

    Durham, North Carolina, 27713, United States

  • Johns Hopkins Pediatric Neurology

    Baltimore, Maryland, 21287, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Hospital

    Orlando, Florida, 32827, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Stanford University

    Stanford, California, 94305, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • University of Wisconsin (Madison)

    Madison, Wisconsin, 53792, United States

  • Washington Unviersity School of Medicine

    St Louis, Missouri, 63110, United States