T-Cell Vaccination in Multiple Sclerosis (MS)

NCT ID: NCT00220428

Last Updated: 2007-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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

Clinical immunologic and neuroradiologic evaluation.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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T-Cell Vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Anat Achiron, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sackler School of Medicine

Locations

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Multiple Sclerosis Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Anat Achiron, MD PhD

Role: CONTACT

972-3-5303932

Matilda Mandel, MD

Role: CONTACT

972-3-5305309

Facility Contacts

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Anat Achiron, MD PhD

Role: primary

972-3-5303932

Matilda Mandel, MD

Role: backup

972-3-5304081

Other Identifiers

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SHEBA-98-1754-AA-CTIL

Identifier Type: -

Identifier Source: org_study_id

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