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
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: ETIMS
Phase 1
Phase 2

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

Resource links provided by NLM:


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 ]
  • Number of Adverse Events [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]

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

Detailed Description:

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.

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

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

Publications:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01414634     History of Changes
Other Study ID Numbers: inims-oo1
Study First Received: August 8, 2011
Results First Received: January 24, 2014
Last Updated: April 8, 2015
Health Authority: Germany: Paul-Ehrlich-Institut
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 30, 2015