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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT03280056
Eligibility Criteria:
Inclusion Criteria:
* ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
* Having onset of ALS disease symptoms, including limb weakness within 24 months at the Screening Visit.
* ALSFRS-R ≥ 25 at the screening Visit.
* Upright slow vital capacity (SVC) measure ≥ 65% of predicted for gender, height, and age at the screening Visit.
* Rapid progressors
* Participants taking a stable dose of Riluzole are permitted in the study
* Citizen or permanent resident of the United States or Canadian citizen able to travel to a US site for all follow-up study visits
Exclusion Criteria:
* Prior stem cell therapy of any kind
* History of autoimmune or other serious disease (including malignancy and immune deficiency) that may confound study results
* Current use of immunosuppressant medication or anticoagulants (per Investigator discretion)
* Exposure to any other experimental agent or participation in an ALS clinical trial within 30 days prior to Screening Visit
* Use of RADICAVA (edaravone injection) within 30 days of screening or intent to use edaravone at any time during the course of the study including the follow up period
* Use of non-invasive ventilation (BIPAP), diaphragm pacing system or invasive ventilation (tracheostomy)
* Feeding tube
* Pregnant women or women currently breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03280056
Study Brief:
Protocol Section:
NCT03280056