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T-Cell Vaccination in Multiple Sclerosis (MS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00220428
First received: September 14, 2005
Last updated: January 23, 2007
Last verified: January 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
 Biological: T-Cell Vaccination
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

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

Estimated Enrollment: 20
Study Start Date: July 1998
Estimated Study Completion Date: December 2007
Detailed Description:

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

Clinical immunologic and neuroradiologic evaluation.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220428     History of Changes
Other Study ID Numbers: SHEBA-98-1754-AA-CTIL
Study First Received: September 14, 2005
Last Updated: January 23, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
T cell

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013