T Cell Vaccination in Patients With Progressive Multiple Sclerosis
Autologous T Cell Vaccination With Line Specific for 9 Myelin Peptides in Patients With Progressive / Relapsing Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- T cell vaccination
Placebo
- multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides)
What it measured
Main measures
EDSS changes
one year
Disability progressionRelapse rate of MS
one year follow up
RelapsesPASAT test
one year
Thinking and memoryNine hole PEG test
one year
timed ten meter walking
one year
Walking and mobility
Other measures (1)
Quantitative MRI evaluation
one year
MRI lesionsBrain volume loss
Who could take part
Relapsing and progressive · 18 to 60 · EDSS 3.0 to 7.0
Show the full criteria
Inclusion criteria
1. Clinically definite MS (according to Poser's criteria) of the relapsing-progressive type (RPMS). 2. Age: 18-60. 3. EDSS: 3.0 to 7.0. 4. Disease duration: > 1 year. 5. Evidence of disease progression of 1 degree in the EDSS scale, or at least two severe relapses (requiring hospitalization and treatment) during the year prior to inclusion. 6. MRI of the brain with at least 5 lesions in the white matter (T2 imaging). 7. Failure to benefit from other existing treatments according to the guidelines of the Israeli Ministry of Health.
Exclusion criteria
1. Patients with other systemic active disease. 2. Patients who had been treated with immunosuppressive drugs during the 3-6 months depending on the cytotoxicity of the medication used prior to the inclusion. 3. Patients who previously received cellular immunotherapy or who are participating in other experimental protocols. 4. Pregnancy; Pregnant women or women who do not use efficacious contraception (oral contraception, or intra-uterine device). 5. Patients with an additional autoimmune condition unrelated to MS or significant allergy. 6. Patients who cannot fully understand the treatment protocol or are unable to sign the informed consent, or in whom the clinician believes that a follow-up period of at least 12 months will not be possible.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
May 2002
Main results due
Sept 2008
Finished
Mar 2009