Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells (ETIMS)
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.
Multiple Sclerosis, Relapsing-Remitting
|Study Design:||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|
- 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 ]
|Study Start Date:||February 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: ETIMS Dose escalation
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. In this dose escalation study the first patient will receive 1x10^3, the second patient 1x10^5, the third patient 1x10^7, the fourth patient 1x10^8, the fifth patient 5x10^8 and the sixth patient 1x10^9 cells.
injection of peptide-coupled PBMC by i.v. infusion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414634
|Principal Investigator:||Christoph Heesen, MD||Department of Neurology, University Clinic Eppendorf (UKE)|