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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT02943850
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed diagnosis of ALS (Lab-supported Probable, Probable or Definite EI Escorial Criteria)
2. Duration of symptoms ≤ 36 months
3. Progressive weakness in lower extremities, with EMG supported evidence of denervation in both lower extremities.
4. Forced Vital Capacity \>60% of predicted normal in supine.
5. Male/Female; Age: 18 and older
6. Able to provide Informed Consent
7. Be geographically accessible to the study site and able to travel to study site for required visits
8. Have caregiver to assist in the transportation and care required by participation in the study
9. Not taking riluzole or on a stable dose for ≥ 30 days
10. For women of child bearing capacity, negative pregnancy test prior to surgery
11. Medically able to undergo thoracolumbar laminectomy or laminoplasty as determined by the site PI and Neurosurgeon
12. Medically able to tolerate the immunosuppression regimen as determined by the site PI
Exclusion Criteria:
1. Using invasive ventilatory assistance
2. Diagnosis of another active or unstable medical illness that may interfere with study participation at discretion of PI
3. Presence of any of the following conditions:
1. Current drug or alcohol abuse
2. Any known immunodeficiency syndrome
3. Unstable medical condition
4. Unstable psychiatric illness including psychosis and untreated major depression within 90 days of screening
4. Persons of child bearing capacity not willing to practice birth control
5. Receiving any investigational device/biologic/drug in past 30 days or any previous exposure to stem cell therapy
6. Any condition in the lower extremities which precludes serial strength testing
7. Any condition that the Neurosurgeon feels may pose complications for the surgery
8. Any condition or ALS disease phenotype that the site PI feels may interfere with participation in the study or in the interpretation of study endpoints
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02943850
Study Brief:
Protocol Section:
NCT02943850