MSFibroblast

Treatment tested

• Tolerogenic Fibroblasts

Other measures (5)

Inclusion Criteria: 1. Patients willing to sign an informed consent and capable of understanding the features of this clinical trial. 2. Willing to keep a weekly diary and undergo observation for four months 3. Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Possner criteria for clinically defined MS. 4. EDSS scores of 2·0 to 5·5 points assessed at least three months after the last acute attack of MS. Exclusion Criteria: 1. Patients with evidence of active proliferative retinopathy. 2. Patients with poorly controlled diabetes mellitus (HbA1C > 8.5%). 3. Patients with renal insufficiency (Creatinine > 2.5) or failure. 4. Infection as evidenced by WBC count of >15,000 k/cumm and/or temperature >38C. 5. History of organ transplant. 6. History of previous or active malignancy, except for localized cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix 7. History of sickle cell anemia 8. Cardiovascular conditions: 1. Exercise limiting angina ( Canadian Cardiovascular Society Class greater or equal to 3 2. Congestive heart failure (New York Heart Association class greater or equal to 3 3. Unstable angina 4. Acute ST elevation myocardial infarction (MI) within one month 5. Transient ischemic attack or stroke within one month 6. Severe valvular disease

Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases. This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS). Our hypothesis is that the tolerogenic fibroblasts will be well-tolerated and meet our primary objective. In addition, The investigators are optimistic that they will see signs of efficacy based on the following: Neurological assessment of the MS functional composite assessment which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.