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T-Cell Vaccination in Multiple Sclerosis (MS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220428
First Posted: September 22, 2005
Last Update Posted: January 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00220428     History of Changes
Other Study ID Numbers: SHEBA-98-1754-AA-CTIL
First Submitted: September 14, 2005
First Posted: September 22, 2005
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