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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 * | |||||||||
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* 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. |
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