ClinicalTrials.gov NCT00668343. This interventional study provides Class I evidence stating that adding simvastatin 40 mg/day to IFNb 1a 30 microg a week in patients with relapsing-remitting multiple sclerosis may reduce the relapse rate (moderate effect size r = 0.29) (p = 0.01) compared with treatment with IFNb 1a alone.
Despite updating knowledge and a growing number of medications for multiple sclerosis (MS), no definite
treatment is available yet for patients suffering from progressive forms of the disease. Autologous bone marrow derived
mesenchymal stem cell (BM-MSC) transplantation is a promising method proposed as a therapy for MS. Although the
safety of these cells has been confirmed in hematological, cardiac and inflammatory diseases, its efficacy in MS treatment
is still under study.
Patients with progressive MS (expanded disability status scale score: 4.0 –6.50) unresponsive to conventional treatments
were recruited for this study.
Twenty-five patients [f/m: 19/6, mean age: 34.7±7] received a single intrathecal injection of ex-vivo expanded MSCs
(mean dose: 29.5×106 cells). We observed their therapeutic response for 12 months. Associated short-term adverse events
of injection consisted of transient low-grade fever, nausea /vomiting, weakness in the lower limbs and headache. No major
delayed adverse effect was reported. 3 patients left the study for personal reasons. The mean (SD) expanded disability
status scale (EDSS) score of 22 patients changed from 6.1 (0.6) to 6.3 (0.4). Clinical course of the disease (measured by
EDSS) improved in 4, deteriorated in 6 and had no change in 12 patients. In MRI evaluation, 15 patients showed no
change, whereas 6 patients showed new T2 or gadolinium enhanced lesions (1 lost to follow-up).
It seems that MSC therapy can improve/stabilize the course of the disease in progressive MS in the first year after injection
with no serious adverse effects. Repeating the study with a larger sample size, booster injections and longer follow-up
using a controlled study design is advised.
Changes of EDs and mean seizure frequency caused by HD-tDCS were not statistically significant for the whole group; however, this method could improve the patients' working memory scores.
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