Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis
Multiple Sclerosis (MS)
About this trial
This is an interventional treatment trial for Multiple Sclerosis (MS) focused on measuring Multiple Sclerosis (MS), Stem Cells
Eligibility Criteria
Inclusion Criteria:
- Consenting patients fulfilling the Poser's clinical criteria for definite MS
- Age: 18-65, males and females
- Duration of disease: >3 years
- Progressive form of MS: PPMS, SPMS (with/without relapses)
- EDSS score of 3.5 - 6.5
- Failure to currently available, registered - first and second line immunomodulatory treatments (at least one).
- Evidence for new activity of MS during the 3 months before the injection of MSC.
Exclusion Criteria:
- Patients who were treated with cytotoxic medications during the last 3 months prior to the inclusion.
- Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
- Patients with active infections
- Patients with severe cognitive decline or inability to understand and sign the informed consent
- Patients who received any cellular treatment in the past
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
IT- Treated
IV - Treated
Placebo
Injection to IT (Group 1). After 6 months, 8 patients (group 1A) will be treated with MSC once again in IT, and 8 additional patients (group 1B) will receive a placebo.
Injection to IV (Group 2). After 6 months, 8 patients (group 2A) will be treated with MSC once again in IV, and 8 additional patients (group 2B) will receive a placebo.
Placebo at the first injection (group 3). After 6 months, 8 patients (group 3A) will be treated with MSC in IT, and 8 additional patients (group 3B) will be treated with MSC in IV.