Gene therapy after stem cell transplant shows promise for rare brain disease

NCT ID NCT04693598

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

Summary

This study tests a one-time gene therapy infusion (FBX-101) given after a standard stem cell transplant in 6 children with infantile Krabbe disease, a severe genetic disorder affecting the nervous system. The therapy uses a harmless virus to deliver a working copy of the GALC gene, aiming to improve motor skills like sitting independently. The main goals are safety and checking whether the treatment helps children achieve better movement compared to those who only had a stem cell transplant.

What this could mean

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

Active substance

FBX-101 (a gene therapy using a harmless virus to deliver a working copy of the GALC gene)

What this could lead to

If successful, this could improve motor function and quality of life for children with Krabbe disease, offering a better outcome than stem cell transplant alone.

What could go wrong

This is an early-phase trial with only 6 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.

infantile Krabbe disease Krabbe disease lysosomal storage disease

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Michigan Hospitals - Michigan Medicine

    Ann Arbor, Michigan, 48109, United States