The aim is to compare Autologous Blood Stem cells Transplantation (ASCT) versus the immunosuppressive drug Mitoxantrone
The primary aim of the present study is to directly compare the efficacy in terms of activity of the disease, measured by the appearance of new T2 lesions at MRI., and the safety of the two respective treatments, ASCT versus the immunosuppressive drug mitoxantrone, in patients affected by severe forms of MS such as the relapsing remitting or secondary progressive with or without relapses. The study will last at least 6 years (2.5 years for the inclusion of patients and 3.5 years of follow-up) and will foresee the enrolment of 30 patients.
For patients to participate, the following inclusion criteria must be fulfilled:
- 1. Age between 18 and 50 years
- 2. EDSS between 3.5 and 6.5 at screening evaluation
- 3. Secondary progressive form of MS, with a worsening documented by EDSS during the last year, with or without enhancing areas at MRI
- 4. Relapsing-remitting forms of MS which accumulate disability between relapses (relapsing-progressive) with a worsening documented by EDSS during the last year, with enhancing areas at MRI
- 5. Relapsing-remitting forms of MS who do not accumulate disability but who have at least two relapses per year, with enhancing areas at MRI
- 6. Absence of mental and cognitive deficits which can interfere with the capability of providing the informed consent
- 7. Negative pregnancy test
Patient treated with immunomodulating therapies and then with Mitoxantrone will be considered if the cumulative dosage of Mitoxantrone will not exceed 24mg/m2.