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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01815632
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of clinically-definite MS as defined by the McDonald criteria
* Aged 18 - 65 years.
* EDSS of 4.0 to 6 inclusive
* Disease duration \>5 years
* Disease progression (increase in physical disability, not due to major relapse) in preceding year
* Signed, written informed consent
* Willing and able to comply with study visits according to protocol for the full study period
Exclusion Criteria:
* Pregnancy, breastfeeding or lactation
* History of autologous/allogenic bone marrow transplantation or peripheral blood stem cell transplant
* Bone marrow insufficiency
* History of lymphoproliferative disease or previous total lymphoid irradiation
* Immune deficiency
* Current or recent (\<5 years) malignancy
* Chronic or frequent drug-resistant bacterial infections or presence of active infection requiring antimicrobial treatment
* Frequent and/or serious viral infection
* Systemic or invasive fungal disease within 2 years of entry to study
* Significant renal, hepatic, cardiac or respiratory dysfunction
* Contraindication to anaesthesia
* Bleeding or clotting diathesis
* Current or recent (within preceding 12 months) immunomodulatory therapy other than corticosteroid therapy
* Treatment with corticosteroids within the preceding three months
* Significant relapse within preceding 6 months
* Predominantly relapsing-remitting disease over preceding 12 months
* Radiation exposure in the past year other than chest / dental x-rays
* Previous claustrophobia
* The presence of any implanted metal or other contraindication to MRI
* Participation in another experimental study or treatment within the preceding 24 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01815632
Study Brief:
Protocol Section:
NCT01815632