Establish Tolerance In Ms With Peptide-Coupled, Peripheral Blood Mononuclear Cells (ETIMS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was Active, not recruiting
Information provided by:
First received: August 8, 2011
Last updated: August 10, 2011
Last verified: August 2011
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Between the ages of 18 and 55 years.
- Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria
- EDSS score between 1 and 5.5.
- Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone)
- 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.
- Disease duration ≤ 5 years (Only Phase II)
- Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria.
- Abnormal screening/baseline blood tests exceeding any of the limits defined
- Pregnant or breast-feeding female.
- History or signs of immunodeficiency.
- Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.
- History of HIV or positive HIV antibody testing
- Serology indicating active Hepatitis B or C infection.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414634
||Sven Schippling, MD
||Department of Neurology, University Clinic Eppendorf (UKE)
No publications provided
ClinicalTrials.gov processed this record on March 06, 2014
||Sven Schippling, Department of Neurology, University Clinic Eppendorf (UKE)
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 8, 2011
||August 10, 2011
Germany: Federal Institute for Drugs and Medical Devices