Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01745783|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2012
Last Update Posted : December 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Bone marrow mesenchymal stem cells autologous Other: Placebo comparator||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745783
|University Hospital Reina Sofia|
|Córdoba, Spain, 14004|
|University Regional Hospital Carlos Haya|
|Málaga, Spain, 29010|
|University Hospital Virgen Macarena|
|Sevilla, Spain, 41009|
|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|