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T-Cell Vaccination in Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

T-Cell Vaccination

About this trial

This is an interventional educational/counseling/training trial for Multiple Sclerosis focused on measuring T cell

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Multiple Sclerosis CenterRecruiting

Outcomes

Primary Outcome Measures

safety assessment of T-cell vaccination in nonresponding MS patients

Secondary Outcome Measures

Full Information

NCT ID

NCT00220428

First Posted

September 14, 2005

Last Updated

January 23, 2007

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00220428

Brief Title

T-Cell Vaccination in Multiple Sclerosis (MS)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sheba Medical Center

4. Oversight

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

T cell

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

T-Cell Vaccination

Primary Outcome Measure Information:

Title

safety assessment of T-cell vaccination in nonresponding MS patients

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anat Achiron, MD PhD

Phone

972-3-5303932

ACHIRON@POST.TAU.AC.IL

First Name & Middle Initial & Last Name or Official Title & Degree

Matilda Mandel, MD

Phone

972-3-5305309

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anat Achiron, MD PhD

Organizational Affiliation

Sackler School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Multiple Sclerosis Center

City

Ramat Gan

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anat Achiron, MD PhD

Phone

972-3-5303932

Achiron@post.tau.ac.il

First Name & Middle Initial & Last Name & Degree

Matilda Mandel, MD

Phone

972-3-5304081

First Name & Middle Initial & Last Name & Degree

Anat Achiron, MD PhD

12. IPD Sharing Statement

Learn more about this trial

T-Cell Vaccination in Multiple Sclerosis (MS)

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