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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02903537
Study type Interventional
Source Fundació Institut Germans Trias i Pujol
Contact Cristina Ramo, MD.PhD. Neurologist
Phone +34934978433
Email cramot.germanstrias@gencat.cat
Status Recruiting
Phase Phase 1
Start date July 6, 2017
Completion date December 2023

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