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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT03268603
Eligibility Criteria:
Inclusion Criteria:
* All patients will have ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the World Federation of Neurology criteria for the diagnosis of ALS.
* Examination and neurophysiological testing confirm a pure motor syndrome compatible with the diagnosis of ALS. All other possible causes of weakness have been excluded by extensive investigations.
* Age greater than 18 years, if female, must be post-menopausal, had a hysterectomy, or agree to two forms of birth control.
* Permanent resident or citizen of the United States.
* Geographic accessibility to the study site and willingness and ability to comply with follow-up.
* History of a chronic onset of a progressive motor weakness of less than two years duration.
* Subjects must be taking a stable dose of riluzole for at least 30 days prior to enrolment or not be on riluzole, and not have been on it for at least 30 days prior to enrolment (riluzole-naïve subjects are permitted in the study).
* Subjects must be taking a stable dose of oral Radicava® (edaravone) for at least 30 days prior to enrolment or not be on oral Radicava® (edaravone), and not have been on it for at least 30 days prior to enrolment (edaravone-naïve subjects are permitted in the study).
* Able to comply with protocol requirements, including MRI testing.
* Can provide written informed consent.
Exclusion Criteria:
* Use of Radicava® (edaravone) within 30 days of screening or intent to use Radicava® at any time during the course of the study including the follow up period.
* Any clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
* Pulmonary Slow Vital Capacity (SVC) less than 65% of predicted for age, gender, and body type.
* Autoimmunity, including Crohn's disease or rheumatoid arthritis
* Current use of immunosuppressant medication or use of such medication within 4 weeks of Screening visit (Visit 1).
* Malignancy 5 years prior to enrollment, including melanoma,with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline).
* Active systemic or local infection near the lumbar puncture site.
* Inability to lie flat for the duration of intrathecal cell transplantation, or inability to tolerate study procedures for any other reason.
* Other active systemic disease as defined by laboratory abnormalities delineated in Appendix IV.
* Use of herbal medications, nutritional supplements or other unapproved drugs or investigational medicinal products being used or studied for the treatment of ALS.
* Unwilling to forgo initiating the use of any new supplements during participation in the study.
* Enrolled in an investigational drug trial within 30 days of baseline visit
* Prior stem cell therapy for a neurological disease
* Kokmen Short Test of Mental Status score \<32
* Presence of a tracheostomy
* Ventilator dependent
* Pregnancy
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Chronic low back pain requiring invasive procedures (i.e. epidural injections or lumbar spine surgery)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03268603
Study Brief:
Protocol Section:
NCT03268603