Status:
COMPLETED
Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief 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 mon...
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 bloo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01414634
Start Date
February 1 2010
End Date
October 1 2012
Last Update
May 4 2015
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