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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Intranodal administration
Subcutaneous administration interferon-beta
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGClínica Universidad de Navarra
Pamplona, Navarre, Spain
NOT_YET_RECRUITINGSafety as assessed by the occurrence and severity of adverse events
Occurence and severity of adverse events will be recorded
Time frame: 24 months
Neurologic changes
New relapse. Disability progression on Expanded Disability Status Scale (EDSS)
Time frame: 24 months
Radiologic changes
Number of new or enlarging T2 lesions on brain MRI. Number of Gadolinium (Gd)-enhancing T1 lesions on brain MRI
Time frame: 24 months
Annual relapse rate (ARR)
Time frame: 24 months
Expanded Disability Status Scale (EDSS)
Time frame: 24 months
9-Hole Peg Test (9HPT)
Time frame: 24 months
25-Foot Walking Test (T25FW)
Time frame: 24 months
Symbol Digit Modalities Test (SDMT)
Time frame: 24 months
Radiologic preliminary efficacy
Number of new or enlarging T2 lesions on brain MRI. Number of Gadolinium (Gd)-enhancing T1 lesions on brain MRI
Time frame: 24 months
Lymphocyte proliferation to myelin peptides
Time frame: 24 months
Blood Immunomonitoring studies
Time frame: 24 months
Feasibility
Generation of Good Manufacturing Practices (GMP)-grade cell product released according to Quality Control. Feasibility of cellular product injection.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.