T-Cell Vaccination in Multiple Sclerosis (MS)

January 23, 2007 updated by: Sheba Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Recruiting
        • Multiple Sclerosis Center
        • Contact:
        • Principal Investigator:
          • Anat Achiron, MD PhD
        • Contact:
          • Matilda Mandel, MD
          • Phone Number: 972-3-5304081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
safety assessment of T-cell vaccination in nonresponding MS patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Anat Achiron, MD PhD, Sackler School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2007

Last Update Submitted That Met QC Criteria

January 23, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-98-1754-AA-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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