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Tracking Information | |||||||||
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First Received Date † | September 14, 2005 | ||||||||
Last Updated Date | January 23, 2007 | ||||||||
Start Date † | July 1998 | ||||||||
Current Primary Outcome Measures † |
safety assessment of T-cell vaccination in nonresponding MS patients | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00220428 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
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 | ||||||||
Brief Summary | The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients. |
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Detailed Description | Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones. Clinical immunologic and neuroradiologic evaluation. |
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Study Phase | Phase I, Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Educational/Counseling/Training, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study | ||||||||
Condition † | Multiple Sclerosis | ||||||||
Intervention † | Biological: T-Cell Vaccination | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 20 | ||||||||
Completion Date | December 2007 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 16 Years to 60 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Israel | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00220428 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Sheba Medical Center | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | Sheba Medical Center | ||||||||
Verification Date | January 2007 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |