Table 4.
Study calendar. The different visits, examinations, tests and the tolDC administration are detailed on the tabular study schedule overview.
| Screening | Treatment period | Safety follow-up | |||||||||||
| Ts | Baseline (T0) | V1 | V1 +1 day | V2 | V3 | V4 | V5 | V6 | F1 | F3 | F6 | F12 | |
| Informed consent | · | ||||||||||||
| Inclusion and exclusion criteria | · | ||||||||||||
| IFN-γ EliSPOT (T cell reactivity assay) | · | · | ·+1w | ·+1w | · | ||||||||
| Leukapheresis | · | ||||||||||||
| TolDC preparation | · | ||||||||||||
| TolDC treatment | · | · | · | · | · | · | |||||||
| Patient evaluation: | |||||||||||||
| Vital signs (HR, BP, …) | · | · | · | · | · | · | · | · | · | · | · | · | |
| ECG | · | · | · | · | · | · | · | · | · | · | · | · | |
| Blood analysis for safety (1×5 mL EDTA tube and 2×10 mL serum tubes) | · | · | · | · | · | · | · | · | · | · | · | · | |
| Urine pregnancy test | · | · | · | · | · | · | · | · | · | · | · | · | |
| Full neurological examination (EDSS, 9-HPT, T25FW, SDMT, MSQOL-54) |
· | · | |||||||||||
| Pain score after treatment injection | · | · | · | · | · | · | |||||||
| MRI | · | · | · | · | ·+1w | ·+1w | ·+1w | · | · | · | |||
| Immunomonitoring (10×10 mL heparin tubes+1 serum tube) |
· | ·+1w | ·+1w | · | |||||||||
| Biobanking for follow-up immunomonitoring | |||||||||||||
| (Serious) Adverse events and concomitant medication | Continuous | ||||||||||||
BP, Blood Pressure; ECG, Electrocardiogram; EDSS, Expanded Disability Status Scale; 9-HPT, 9 Hole Peg Test; MRI, Magnetic Resonance Imaging; MSQOL-54, Multiple Sclerosis Quality of Life-54; SDMT, Symbol Digit Modalities Test; T25FW, Timed 25 Foot Walk; tolDC, tolerogenic dendritic cells.