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Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS)
The purpose of this study is to determine the safety and tolerability of the intranodal administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the most appropriate regime for the development of future therapeutic trials. To evaluate the preliminary proof of concept by clinical and/or radiological activity and immunological markers.
Details
| Lead sponsor | Fundació Institut Germans Trias i Pujol |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 16 |
| Start date | 2017-07-06 |
| Completion | 2023-12 |
Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Multiple Sclerosis, Chronic Progressive
Interventions
- Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3)
- Interferon-beta
Primary outcomes
- Safety as assessed by the occurrence and severity of adverse events — 24 months
Occurence and severity of adverse events will be recorded - Neurologic changes — 24 months
New relapse. Disability progression on Expanded Disability Status Scale (EDSS) - Radiologic changes — 24 months
Number of new or enlarging T2 lesions on brain MRI. Number of Gadolinium (Gd)-enhancing T1 lesions on brain MRI
Countries
Spain