1-Aim: Multiple sclerosis (MS) is an autoimmune disease characterize by demyelinating plaque in the central nervous system. The disease has no cure and no recognized definite cause yet. Impaired CD4+CD25+FoxP3+ Treg cells are the possible cause. The available therapies are mostly immunosuppressive disease modifying agents. Rapamycin is an immunosuppressive agent with and tolerable side effects. The aim of the present clinical trial is to evaluate the therapeutic effects of rapamycin on the patients with MS.
2-Design: simple sampling method is used for patients. Eight patients were selected.
3- In this study, 8 patients with MS will be treated with rapamycin (2 mg/day) for six months and before and after the therapy the following parameters will be studied.
Number of CD4+CD25+FoxP3+ Treg, FoxP3 expression rate
Th1,2 and 17 cytokine levels, Number and size of the plaques
Relapsing- Remitting MS, MRI records that proved the existence of demyelination, 0-6 expanded disability status scale (EDSS), lack of response to β interferon or glatiramer acetate, stopping β interferon or glatiramer acetate one month before the experimentation .
Primary progressive MS, history of immunosuppressive therapy, side effects of the drug, steroid therapy in the last one month, any sign of infection and cancer, cardiovascular and hematological disorders, high serum cholesterol and using medication for it, history of hepatic cirrhosis or other liver diseases that require treatment, history of C and B hepatitis, active CMV infection, renal diseases which require treatment, active lung diseases, diabetes, hyperthyroidism, infection with HIV, tuberculosis, history of alcohol misuse during last 6 months, phobia from MRI (Claustrophobia) and pregnant and lactating women
Six months of administration of rapamycin 2 mg per day
6- Main variables:
Number of CD4+CD25+FoxP3+ Treg, FoxP3 expression rate, Number and size of the plaques