Gene therapy for gaucher disease: 5-year safety check begins

NCT ID NCT06545136

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

Summary

This study follows 75 people with Gaucher disease type 1 who previously received FLT201 gene therapy. Researchers will monitor them for 5 years to see if the treatment remains safe and if its effects last. The goal is to understand whether a single dose can provide long-term disease control.

What this could mean

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

Active substance

FLT201 (a gene therapy using a harmless virus to deliver a working GBA gene)

What this could lead to

If successful, this could show that a single dose of FLT201 safely controls Gaucher disease for years, reducing or eliminating the need for regular enzyme infusions.

What could go wrong

This is an early-phase follow-up study, so it is small and not designed to prove effectiveness. There may be unknown long-term side effects, and some patients may still need standard treatments.

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.

Gaucher disease Gaucher disease type I

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hospital Quironsalud Zaragoza

    Zaragoza, Spain

  • Hospital de Clinicas de Porto Alegre (HCPA)

    Porto Alegre, Brazil

  • Lysosomal Rare Disorders Research and Treatment Center

    Fairfax, Virginia, 22030-6066, United States

  • Salford Royal Hospital

    Salford, United Kingdom