Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis
This is a phase I / II for the evaluation of the safety and feasibility of intravenous infusion of mesenchymal cells from autologous bone marrow in patients with Multiple Sclerosis.
Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and safe and can be effective in treating patients suffering from multiple sclerosis.
|Multiple Sclerosis||Other: Bone marrow mesenchymal stem cells autologous Other: Placebo comparator||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Trial Phase I / II Multicenter, Randomized, Crossover, Double-blind Evaluation of the Safety and Feasibility of Systemic Therapy With Mesenchymal Cells Derived From Autologous Bone Marrow in Patients With Multiple Sclerosis|
- Absence of unexpected serious adverse reactions as a measure of safety and reduction in number and volumes of the lesions on magnetic resonance image [ Time Frame: 12 months ]
- Differences the results obtained in the two groups of patients due to determined parameters. [ Time Frame: 12 months ]
Secondary variables consist of differences the results obtained in the two groups of patients (treated versus treated at day 0 to day +180) at 12 month follow-up with respect to the following parameters:
- Disease activity on magnetic resonance (used one single combined index activity consisting of the presence of new or enlarged T2 or new or recurrence of injury).
- Changes in Expanded Disability Status Scale (EDSS).
- Changes Multiple Sclerosis Functional Composite (MSFC).
- Changes in quality of life scales
- Outbreaks: number and proportion of time off outbreaks.
- Disease-free patients (no sprouts, no progression and no activity in the RM).
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Receive a single IV administration of cellular product (Bone marrow mesenchymal stem cells autologous) on Day 0 and placebo infusion on day + 180.
Dose: 1-2x10^6 cells/Kg
Other: Bone marrow mesenchymal stem cells autologous
Infusion of mesenchymal cells from autologous bone marrow in a dose of 1-2x106 cells / kg
Placebo Comparator: Placebo Comparator
Receive a placebo infusion on day 0 and a single administration cellular product on day +180. Dose: 1-2x10^6 cells/Kg
Other: Placebo comparator
Lactated Ringer's solution, 2.5% glucose and 1% human albumin.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745783
|Contact: Ana Cardesa||0034 firstname.lastname@example.org|
|University Hospital Reina Sofia||Recruiting|
|Córdoba, Spain, 14004|
|Contact: Eduardo Agüera, MD 957010482; email@example.com|
|Principal Investigator: Eduardo Agüera, MD|
|University Regional Hospital Carlos Haya||Recruiting|
|Málaga, Spain, 29010|
|Contact: Victoria Fernández, MD 951291135 firstname.lastname@example.org|
|Principal Investigator: Victoria Fernández, MD|
|University Hospital Virgen Macarena||Recruiting|
|Sevilla, Spain, 41009|
|Contact: Guillermo Izquierdo, MD 607657605 email@example.com|
|Principal Investigator: Guillermo Izquierdo, MD|
|Principal Investigator:||Guillermo Izquierdo, MD||Section Chief of Neurology, University Hospital Virgen Macarena, Spain|
|Principal Investigator:||Eduardo Agüera, MD||Section of Neurology, University Hospital Reina Sofía, Spain|
|Principal Investigator:||Victoria Fernández, MD||Section of Neurophysiology, University Regional Hospital Carlos Haya, Spain|
|Study Chair:||Inmaculada Concepción Herrera, MD||Technical Director of the Cell Therapy Unit, University Hospital Reina Sofia, Spain|