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T-Cell Vaccination in Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT00220428
Recruitment Status : Unknown
Verified January 2007 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : January 24, 2007
Sponsor:
Information provided by:
Sheba Medical Center

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: T-Cell Vaccination Phase 1 Phase 2

Detailed Description:

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

Clinical immunologic and neuroradiologic evaluation.


Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial
Study Start Date : July 1998
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. safety assessment of T-cell vaccination in nonresponding MS patients


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220428


Contacts
Contact: Anat Achiron, MD PhD 972-3-5303932 ACHIRON@POST.TAU.AC.IL
Contact: Matilda Mandel, MD 972-3-5305309

Locations
Israel
Multiple Sclerosis Center Recruiting
Ramat Gan, Israel
Contact: Anat Achiron, MD PhD    972-3-5303932    Achiron@post.tau.ac.il   
Contact: Matilda Mandel, MD    972-3-5304081      
Principal Investigator: Anat Achiron, MD PhD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Anat Achiron, MD PhD Sackler School of Medicine

ClinicalTrials.gov Identifier: NCT00220428     History of Changes
Other Study ID Numbers: SHEBA-98-1754-AA-CTIL
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 24, 2007
Last Verified: January 2007

Keywords provided by Sheba Medical Center:
T cell

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs