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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
  Purpose

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.


Condition Intervention Phase
Relapsing-remitting MS
 Biological: ETIMS
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9
Study Start Date: February 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: ETIMS
    injection of peptide-coupled PBMC by i.v. infusion
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414634

Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Sven Schippling, MD Department of Neurology, University Clinic Eppendorf (UKE)
  More Information

No publications provided

Responsible Party: Sven Schippling, Department of Neurology, University Clinic Eppendorf (UKE)
ClinicalTrials.gov Identifier: NCT01414634     History of Changes
Other Study ID Numbers: inims-oo1
Study First Received: August 8, 2011
Last Updated: August 10, 2011
Health Authority: Germany: Paul-Ehrlich-Institut
Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 23, 2013