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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT01719159
Eligibility Criteria:
Inclusion Criteria:
* Between the age of 18 and 65 years of age (nonfertile women or fertile women with effective contraceptive methods)
* Progressive MS since at least three years
* Some kind of documented progression of neurological symptoms during the previous two years.
* Expanded Disability Status Scale (EDSS) 4,0 - 7.0 (inclusive) (basically spared arm functions)
* Conventional therapy not indicated, contraindicated or failed
* Judged as compliant with the protocol
Exclusion Criteria:
* Eligible for any of the conventional MS therapies
* Relapsing remitting multiple sclerosis (RRMS)
* Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture
* Cognitive defect making informed consent unreliable
* Any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist
* Severe, uncontrolled heart disease
* Pregnant or lactating women
* Patients having contraindication for or otherwise not compliant with MRI investigations
* Documented vulnerability to infections
* Simultaneous treatment with other immunosuppressive drugs
* Documented allergy or intolerance to Rituximab
* Severe psychiatric condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01719159
Study Brief:
Protocol Section:
NCT01719159