A Phase 1/2 interventional study of multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides) and T cell vaccination in Multiple Sclerosis, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-10-07.
Sponsored by Hadassah Medical Organization · Phase 1/2, Interventional, and Treatment
This is a double blind phase I-II clinical trial with multiple autologous T cell vaccinations using T cell lines reactive to 9 different myelin peptides of MBP, MOG and PLP, in patients with relapsing progressive Multiple Sclerosis.
This trial is a phase I/II double-blind controlled clinical trial designed to evaluate the safety and clinical efficacy of multiple autologous T-cell vaccinations (on days 1, 30, 90 and 180) in progressive MS patients which showed severe progression/deterioration in the functional status (at least, one degree in the EDSS scale) during the last year, or at least one severe relapse. The patients will be from our MS clinic and will be randomized (by computer) into two groups according to: age, disease duration, disease severity and progression rate. One group (2/3 of the patients) will receive the active treatment, i.e. TCV, and the other group (1/3 of the patients) will receive sham treatment (injection of sterile normal saline). The treating nurse, the treating physician, the examining neurologist (the one who will perform the neurological evaluation) and the patient will be blinded for the treatment.
OBJECTIVES AND SIGNIFICANCE OF THE TRIAL
A. To develop a new cell therapeutic modality for treating MS patients using attenuated autologous anti-MBP, anti-PLP and anti-MOG autoreactive T-cells as vaccines. The immune response induced by this vaccination will be directed specifically against the T-cells attacking the patient's nerve system (specifically the myelin sheath).
B. To study and characterize these autoreactive T-cells in MS patients. The number and function of such cells in the course of the relapse of the disease, as well as during the periods of remissions, will be studied.
C. To study the clinical efficacy of T-cell vaccination with attenuated anti-MBP and anti-MOG autologous T-cells on MS. The parameters to be examined will include: change in the disability status (by the EDSS disability scale, as well as by ambulation index and several other functional tests), the change in the relapse rate and in the timed 10-meters walking test, the PASAT test and the 9-hole peg test. MRI parameters will represent additional endpoints and will include: the changes in the total burden of the disease and in the quantity of irreversible damage (cortical atrophy and axonal loss). In addition, the effects of this treatment on the immune responses (i.e. number and proportion of activated lymphocytes, number and proportion of anti-myelin reactive lymphocytes in the peripheral blood and IgG antibody levels in the cerebrospinal fluid) will be evaluated in the treated MS patients.
The significance and importance of the study are outlined as follows:
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
multiple T cell vaccinations against nine myelin peptides at days 1, 30, 90, 180
Biological: T cell vaccination
saline injections subcutaneously at the same 4 time points with active treatment
Biological: multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides)
multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides at days 1, 30,90,180
Also known as: multiple subcutenous injections of saline at days 1, 30,90,180.
Multiple injections of autologous T cell lines reactive to 9 myelin peptides.
EDSS changes
Follow up in changes in the EDSS score
Time frame: one year
Relapse rate of MS
recording of the relapses of MS during the year of the study and the prior to the study
Time frame: one year follow up
PASAT test
recording of the performance in the PASAT test during the one year of the study
Time frame: one year
Nine hole PEG test
recording of the performance in the Nine hole PEG test test during the one year of the study
Time frame: one year
timed ten meter walking
recording of the performance in the timed ten meter walking test during the one year of the study
Time frame: one year
Quantitative MRI evaluation
the burden of T2 lesions load, of the hypo-intense T1 lesions, of the Gadolinium enhancing lesions and of the brain atrophy will be evaluated at the end of the study and compared to the baseline values
Time frame: one year
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization