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BackgroundT-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled.AimTo evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial.MethodologyTwenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10–30×106 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis.ResultsAt one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (−0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly.ConclusionsThis is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted.Trial RegistrationClinicalTrials.gov NCT01448252

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In the light of recent observations reporting that B-lymphocytic leukemia (B-CLL) cells may express a variety of myelomonocytic antigens, 28 patients with B-CLL and B-leukemic lymphocytic lymphoma were studied for the presence of these antigens using monoclonal antibodies to detect CD13, CD33, CD15 and CD14. Analysis of immunofluorescence (IF) was carried out by two procedures; one which employed the standard conventional method of gating used in our laboratory for flow cytometry, while the other procedure increased the sensitivity of the analysis, by moving the marker for IF to the left, so as to widen the gate to include more cells with low IF. Using the conventional methodology, the mean proportion of cells considered positive was less than 3% for any of the 4 markers studied. In only a few patients were 5% or more of the B-CLL cells positive for some of the markers studied (3 patients with 6.2-11.3% CD13+; 2 with 6.0-9.6% CD14+, and one with 11.8% CD15+ cells). No case had more than 2.5% + CD33+ cells. The second procedure with a wider gate to enhance sensitivity for less positive cells, increased the number of positive cells for any of the markers in only 4 patients. These results are contradictory to others reported recently, and some of the possible causes for this discrepancy are discussed. It is suggested that more useful data may be obtained if the level of staining intensity and patterns of positive staining are documented in the future.

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