: This is a request to continue a Phase I-II T-cell vaccine trial for the treatment of Secondary Progressive Multiple Sclerosis (SPMS). In this trial, 84 patients have been randomized, and are receiving injections of vaccine or placebo. Enrollment and vaccine production was completed in early September 2002. This single-center, randomized, double-blind, placebo-controlled phase II clinical trial was designed to test the safety and efficacy of autoglous T-cell vaccination for the treatment of SPMS. Forty-two patients have been assigned to either placebo or T-cell vaccine treatment arms; all receive a total of 11 injections of vaccine or placebo over a 24-month period, with a 12-month follow-up phase after the last injection. The study is designed to evaluate efficacy using MRI parameters as a primary outcome measure, EDSS and MSFC as secondary endpoints, and analysis of immunological function as a tertiary endpoint. Baseline data will be compared with data collected, longitudinally, at regular intervals throughout the treatment and follow-up phases of the trial. Specific hypotheses to be tested include: 1) MRI evidence of disease activity will either be reduced, or remain stable in patients assigned to the vaccine arm, compared with those assigned to placebo; 2) clinical measures of disease activity will stabilize or improve in vaccine, but not placebo recipients; and 3) MRI and clinical improvements in vaccine recipients will be accompanied by vaccine-specific regulatory immune responses.
| Lund, Brett T; Ashikian, Nazely; Ta, Huy Q et al. (2004) Increased CXCL8 (IL-8) expression in Multiple Sclerosis. J Neuroimmunol 155:161-71 |
