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 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT06841068
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-60 years.
* Diagnosed with primary or secondary progressive MS according to the 2017 revised McDonald criteria.
* Expanded Disability Status Scale (EDSS) of 3.0 to 8.0 with at least one functional scale that is not vision or sensory or brainstem or cognitive or bowel/bladder that is scoring 3.0 or greater.
* Clinically stable as determined by their neurologist for the past 6 months.
* On no disease-modifying therapy (DMT) for at least 6 months, or on the same DMT for at least 6 months before study entry.
* Can give informed consent.
* Women of child-bearing age must practice adequate contraception techniques in the eye of the investigator and continue to do so during the study period.
* Must be a good candidate, known for compliance for example, in the opinion of the investigators.
Exclusion Criteria:
* Participation in another clinical trial within the last 30 days.
* Severe allergic reactions to any component of the study treatments.
* Significant comorbidities.
* Active infections or malignancies.
* History of a malignancy within the past two years except for skin cancer that has been excised and controlled with only surgical treatment, not requiring chemotherapy or radiotherapy.
* Any medical condition that the investigator deems as unsuitable with therapy.
* Prior organ, tissue, or stem cell transplant or cell therapy within 3 years of study entry
* A diagnosis of a progressive neurological disorder other than multiple sclerosis.
* Inability to have an MRI scan.
* Inability to have a lumbar puncture, for example severe bleeding diathesis.
* Pregnant or breastfeeding or intention to become pregnant during the study.
* The results of the following laboratory results deemed suitable by the investigators: CBC with diff, CMP, INR, aPTT, Hepatitis C serology, HIV serology, RPR.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06841068
Study Brief:
Protocol Section:
NCT06841068