Gene therapy hope for rare brain disease in children

NCT ID NCT04283227

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a single infusion of OTL-200 gene therapy in 6 people with late juvenile metachromatic leukodystrophy (MLD), a rare genetic disease that damages the brain and nerves. The therapy uses the patient's own blood stem cells, modified to produce a missing enzyme. Researchers will follow participants for 8 years to see if the treatment is safe and can slow the disease.

What this could mean

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

Active substance

OTL-200 gene therapy

What this could lead to

If successful, this could provide a one-time treatment that slows or stops the progression of late juvenile MLD, a severe and rare brain disease.

What could go wrong

This is a very small early-phase trial with only 6 participants, so results may not apply to everyone. Gene therapies can have unexpected side effects, and long-term benefits are not yet proven.

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.

lysosomal storage disease metachromatic leukodystrophy metachromatic leukodystrophy, juvenile form

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ospedale San Raffaele - Telethon Institute for Gene Therapy (OSR-TIGET)

    Milan, 20132, Italy