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:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT02116634
Eligibility Criteria:
Inclusion Criteria:
1. sporadic ALS according to escorial criteria
2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
3. mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
4. normal polysomnography
5. Signed consent form
Exclusion Criteria:
1. pregnancy or lactation,
2. vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
3. Hospitalization due to serious illness in the last two months
4. survival time less than two years
5. Hypersensitivity to any component used in the cell culture
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02116634
Study Brief:
Protocol Section:
NCT02116634