Clin2
NCT05747261Possibly a fitRecruiting

Single-dose gene therapy for children with spinal muscular atrophy

Spinal Muscular Atrophy (SMA)

Part of Brain & nervous system clinical trials.

This trial tests a one-time gene therapy given through a vein to add a working SMN gene in children with spinal muscular atrophy (SMA). It mainly looks at safety first, and also checks early signs that treatment helps the disease.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
40 people
Ages
Up to 8 months
Study type
Interventional

Who can take part

  • Child must be under 240 days old when the parent/guardian signs consent
  • Child must have confirmed 5q-SMA with specific SMN1 and SMN2 gene results (2 or 3 SMN2 copies)
  • If symptoms are present, they must have started very early (by 180 days after birth)
  • Parent/guardian must be able to understand study information and follow study procedures
  • Child must not need long daily breathing support (16+ hours/day) or a tracheostomy
  • Child must have low enough pre-existing AAV9 antibodies (tested at screening)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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