Phase 2
N=9
Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells
Multiple Sclerosis, Relapsing-Remitting
Bottom Line
View on ClinicalTrials.gov: NCT01414634 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ETIMS (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
— | — |
| PRIMARY Number of Adverse Events |
14 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
- Splenectomy
- 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
Data sourced from ClinicalTrials.gov (NCT01414634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.