T-Cell Vaccination in Multiple Sclerosis (MS)

This study is currently recruiting participants.

Verified by Sheba Medical Center, January 2007

First Received: September 14, 2005 Last Updated: January 23, 2007 History of Changes

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00220428

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 I Phase II

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

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

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

Keywords provided by Sheba Medical Center:

T cell

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on September 11, 2009