Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Multiple Sclerosis - Relapsing Remitting
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02903537
- Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Principal Investigator: Cristina Ramo, MD.PhD.Neurologist Badalona Hospital Germans Trias i Pujol. Neurology service. Multiple Sclerosis department Study Director: Eva Martínez-Cáceres, MD.PhD.Immunology Badalona Hospital Germans Trias i Pujol. Immunology
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