Clinical Trial: Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS)

Brief 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.


Detailed Summary:

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.


Sponsor: Fundació Institut Germans Trias i Pujol

Current Primary Outcome:

  • Safety as assessed by the occurrence and severity of adverse events [ Time Frame: 24 months ]
    Occurence and severity of adverse events will be recorded
  • Neurologic changes [ Time Frame: 24 months ]
    New relapse. Disability progression on Expanded Disability Status Scale (EDSS)
  • Radiologic changes [ Time Frame: 24 months ]
    Number of new or enlarging T2 lesions on brain MRI. Number of Gadolinium (Gd)-enhancing T1 lesions on brain MRI


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 24 months ]
    Number of new or enlarging T2 lesions on brain MRI. Number of Gadolinium (Gd)-enhancing T1 lesions on brain MRI
  • Lymphocyte proliferation to myelin peptides [ Time Frame: 24 months ]
  • Blood Immunomonitoring studies [ Time Frame: 24 months ]
  • Feasibility [ Time Frame: 6 months ]
    Generation of Good Manufacturing Practices (GMP)-grade cell product released according to Quality Control. Feasibility of cellular product injection.


Original Secondary Outcome: Same as current

Information By: Fundació Institut Germans Trias i Pujol

Dates:
Date Received: July 21, 2016
Date Started: September 2016
Date Completion: September 2019
Last Updated: September 15, 2016
Last Verified: September 2016