Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT07265232
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to give written informed consent for participation in the study.
2. Genetic confirmation of SMA (biallelic deletion or mutation of SMN1).
3. SMA clinical phenotype and condition, that in the opinion of the treating physician, treatment with Vesemnogene will likely be beneficial.
4. Absence of contraindications for spinal tap procedure or administration of intrathecal therapy.
5. Total AAV antibody titres \< 1:20 as determined by ELISA assay.
6. Normal liver function (AST/ALT \< 3XULN, Bilirubin \<3.0 mg/dL).
7. Unable to access or failure to respond to currently available curative treatments for SMA.
Exclusion Criteria:
None
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT07265232
Study Brief:
Protocol Section:
NCT07265232