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Evaluation of Safety and Efficacy of Gene Therapy Drug in the Treatment of Spinal Muscular Atrophy (SMA) Type 2 Patients

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of May 2025 to Apr 22, 2025 · Site details revised at 5 of 5 sitesv7 Show 2 more changesShow less
    • Primary completion date changed from estimate of May 2025 to Apr 22, 2025
    • Site details revised at 5 of 5 sites
  2. Eligibility criteria expanded, about 7 wordsv6 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2023 to Aug 1, 2023 · Site details revised at 5 of 5 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2023 to Aug 1, 2023
    • Site details revised at 5 of 5 sites
  5. 2 versions Re-verified since Jun 12, 2023, no change to tracked fieldsv2-v3
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study will evaluate safety and efficacy of intrathecal delivery of GC101 gene therapy drug as a treatment of spinal muscular atrophy Type 2 (SMA 2) patients.
Trial Details
NCT Number NCT05901987
Lead Sponsor GeneCradle Inc
Conditions SMA II
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov