Gene therapy could replace risky transplants for kids with hurler syndrome

NCT ID NCT06149403

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests a new gene therapy called OTL-203 against the standard stem cell transplant for children with Hurler syndrome, a rare genetic disorder. The therapy uses the child's own blood stem cells, modified to produce the missing enzyme, aiming to improve survival and reduce complications. 41 participants are enrolled, and the study compares event-free survival between the two treatments.

What this could mean

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

Active substance

OTL-203 (gene therapy using a patient's own stem cells modified to produce the missing IDUA enzyme)

What this could lead to

If successful, OTL-203 could become a safer and more effective alternative to standard stem cell transplant for children with Hurler syndrome, potentially reducing complications and improving outcomes.

What could go wrong

This is an early Phase 3 trial with only 41 participants, so results may not apply to all patients. Gene therapy carries risks like immune reactions or the treatment not working as expected.

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.

Hurler syndrome mucopolysaccharidosis Mucopolysaccharidosis I

As listed by the trial registrant

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

Contacts and locations

Locations

  • Manchester University NHS Foundation Trust Blood and Marrow Transplant Programme, Royal Manchester Children's Hospital

    Manchester, M13 9WL, United Kingdom

  • Ospedale San Raffaele

    Milan, 20131, Italy

  • Princess Maxima Center

    Utrecht, 3584 CS, Netherlands

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • University of Minnesota, Pediatrics

    Minneapolis, Minnesota, 55455, United States