Status:
COMPLETED
T Cell Vaccination in Patients With Progressive Multiple Sclerosis
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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 progre...
Eligibility Criteria
Inclusion
- Clinically definite MS (according to Poser's criteria) of the relapsing-progressive type (RPMS).
- Age: 18-60.
- EDSS: 3.0 to 7.0.
- Disease duration: \> 1 year.
- 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.
- MRI of the brain with at least 5 lesions in the white matter (T2 imaging).
- Failure to benefit from other existing treatments according to the guidelines of the Israeli Ministry of Health.
Exclusion
- Patients with other systemic active disease.
- 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.
- Patients who previously received cellular immunotherapy or who are participating in other experimental protocols.
- Pregnancy; Pregnant women or women who do not use efficacious contraception (oral contraception, or intra-uterine device).
- Patients with an additional autoimmune condition unrelated to MS or significant allergy.
- 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.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01448252
Start Date
May 1 2002
End Date
March 1 2009
Last Update
October 7 2011
Active Locations (1)
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1
Dept of Neurology,Hadassah ein-Kerem
Jerusalem, Israel, 91120