Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
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.
Phase I dose ascending ("best of five") clinical trial. First group will start by intranodal injection in cervical lymph nodes of 5*10^6 tolDC-VitD3. Up titration depending on security outcomes to 10*10^6 tolDC-VitD3, same route in second cohort dose and next uptitration to 15*10^6 tolDC-VitD3. Six cycles per patient with the following schema: for the first four cycles the administration will be each 2 weeks, for the remaining 2 cycles administration each 4 weeks. A last cohort with the dose identified in the previous groups, administered in patients treated with beta interferon, same route, same dose schema. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02861014 -
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
|
Phase 3 | |
| Terminated |
NCT01435993 -
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
|
Phase 1 | |
| Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
| Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
| Completed |
NCT02410200 -
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
|
Phase 2 | |
| Completed |
NCT03975413 -
Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
|
||
| Completed |
NCT05080270 -
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
|
Early Phase 1 | |
| Completed |
NCT01116427 -
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT01108887 -
An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
|
N/A | |
| Completed |
NCT01141751 -
An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy
|
N/A | |
| Completed |
NCT00097331 -
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT01909492 -
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
|
||
| Completed |
NCT04121221 -
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
|
Phase 3 | |
| Withdrawn |
NCT04880577 -
Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis
|
Phase 2 | |
| Not yet recruiting |
NCT05290688 -
Cellular microRNA Signatures in Multiple Sclerosis
|
N/A | |
| Completed |
NCT04528121 -
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT04002934 -
Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis
|
Phase 2 | |
| Recruiting |
NCT05019248 -
Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
|
||
| Completed |
NCT04580381 -
Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
|
||
| Completed |
NCT00071838 -
Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis
|
Phase 2 |