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Establish Tolerance In Ms With Peptide-Coupled, Peripheral Blood Mononuclear Cells (ETIMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01414634
First received: August 8, 2011
Last updated: August 10, 2011
Last verified: August 2011
History of Changes

August 8, 2011
August 10, 2011
February 2010
October 2012   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01414634 on ClinicalTrials.gov Archive Site
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Establish Tolerance In Ms With Peptide-Coupled, Peripheral Blood Mononuclear Cells
ESTABLISH TOLERANCE IN MS WITH PEPTIDE-COUPLED, PERIPHERAL BLOOD MONONUCLEAR CELLS - A MRI-CONTROLLED, SINGLE CENTER, BASELINE-TO-TREATMENT CROSS-OVER, PHASE I/IIA TRIAL IN RELAPSING-REMITTING MS PATIENTS

Open-label, single center, baseline-to-treatment cross-over phase I/IIa clinical trial to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous PBMC chemically coupled with a cocktail containing seven immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS patients.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing-remitting MS
Biological: ETIMS
injection of peptide-coupled PBMC by i.v. infusion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9
Not Provided
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Between the ages of 18 and 55 years.
  2. Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria
  3. EDSS score between 1 and 5.5.
  4. Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone)
  5. Patients are able to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
  6. Disease duration ≤ 5 years (Only Phase II)

Exclusion Criteria:

  1. Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria.
  2. Abnormal screening/baseline blood tests exceeding any of the limits defined
  3. Pregnant or breast-feeding female.
  4. History or signs of immunodeficiency.
  5. Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.
  6. Splenectomy
  7. History of HIV or positive HIV antibody testing
  8. Serology indicating active Hepatitis B or C infection.
  9. Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01414634
inims-oo1
Yes
Sven Schippling, Department of Neurology, University Clinic Eppendorf (UKE)
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Sven Schippling, MD Department of Neurology, University Clinic Eppendorf (UKE)
Universitätsklinikum Hamburg-Eppendorf
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP