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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01414634
First received: August 8, 2011
Last updated: April 8, 2015
Last verified: April 2015

August 8, 2011
April 8, 2015
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 ]
  • Number of Adverse Events [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 Multiple Sclerosis With Peptide-coupled, Peripheral Blood Mononuclear Cells - A MRI-controlled, Single Center, Phase I Trial in Relapsing-remitting MS Patients
Open-label, single center, phase I clinical trial to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS patients.
Open-label, single center, phase I dose-escalation study to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of a single infusion of autologous peripheral blood mononuclear cells chemically coupled with seven myelin peptides (MOG1-20, MOG35-55, MBP13-32, MBP83-99, MBP111-129, MBP146-170, and PLP139-154) in Multiple Sclerosis patients who were off-treatment for standard therapies. Neurological, magnetic resonance imaging, laboratory, and immunological examinations were performed to assess the safety, tolerability, and in vivo mechanisms of action of this regimen.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
Biological: ETIMS
injection of peptide-coupled PBMC by i.v. infusion
  • Experimental: ETIMS 1x10^3
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10^3 cells.
    Intervention: Biological: ETIMS
  • Experimental: ETIMS 1x10^5
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10^5 cells.
    Intervention: Biological: ETIMS
  • Experimental: ETIMS 1x10^7
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10^7 cells.
    Intervention: Biological: ETIMS
  • Experimental: ETIMS 1x10^8
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10^8 cells.
    Intervention: Biological: ETIMS
  • Experimental: ETIMS 5x10^8
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 5x10^8 cells.
    Intervention: Biological: ETIMS
  • Experimental: ETIMS 1x10^9
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10^9 cells.
    Intervention: Biological: ETIMS
  • Experimental: ETIMS 2.5x10^9
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 2.5x10^9 cells.
    Intervention: Biological: ETIMS
  • Experimental: ETIMS 3x10^9
    The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 3x10^9 cells.
    Intervention: Biological: ETIMS
Lutterotti A, Yousef S, Sputtek A, Stürner KH, Stellmann JP, Breiden P, Reinhardt S, Schulze C, Bester M, Heesen C, Schippling S, Miller SD, Sospedra M, Martin R. Antigen-specific tolerance by autologous myelin peptide-coupled cells: a phase 1 trial in multiple sclerosis. Sci Transl Med. 2013 Jun 5;5(188):188ra75. doi: 10.1126/scitranslmed.3006168.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2012
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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01414634
inims-oo1
Yes
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Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Christoph Heesen, MD Department of Neurology, University Clinic Eppendorf (UKE)
Universitätsklinikum Hamburg-Eppendorf
April 2015

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