T-Cell Vaccination in Multiple Sclerosis (MS) | NCT00220428

Studies
T-Cell Vaccination in Multiple Sclerosis (MS)

NCT00220428

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jan 24, 2007Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Multiple Sclerosis

Interventions

T-Cell Vaccination

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1998

Primary Completion Date

Not provided

Completion Date

Dec 2007

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2007

Last Update Posted Date

Jan 24, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
T-Cell Vaccination	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety assessment of T-cell vaccination in nonresponding MS patients

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anat Achiron, MD PhD	Contact	972-3-5303932		ACHIRON@POST.TAU.AC.IL
Matilda Mandel, MD	Contact	972-3-5305309

Overall Officials

Name	Affiliation	Role
Anat Achiron, MD PhD	Sackler School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Multiple Sclerosis Center	Recruiting	Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided