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NCT00220428 Clinical Trial

T-Cell Vaccination in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

Official title:
The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00220428
Other study ID # SHEBA-98-1754-AA-CTIL
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received September 14, 2005
Last updated January 23, 2007
Start date July 1998
Est. completion date December 2007

Study information
Verified date January 2007
Source Sheba Medical Center
Contact Anat Achiron, MD PhD
Phone 972-3-5303932
Email ACHIRON@POST.TAU.AC.IL
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.

Description:

Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones.

Clinical immunologic and neuroradiologic evaluation.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

- Definite MS (post criteria)

- Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years.

- Disease duration > 1 year

- Expanded Disability Status Scale (EDSS) between 0-6

- Brain magnetic resonance imaging (MRI) compatible with MS

- Not involved in any other clinical trials

- No other systemic disease

Exclusion Criteria:

- Does not comply with the above

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Biological:
• T-Cell Vaccination

Locations
Country Name City State
Israel Multiple Sclerosis Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary safety assessment of T-cell vaccination in nonresponding MS patients
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