NCT01745783

Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study population will consist of a total of 30 patients diagnosed with multiple sclerosis, who meet all inclusion criteria and none of the exclusion set and express their agreement to participate in the study by signing the informed consent of those whose results can be clinically evaluable. Selected patients who consent will be enrolled in the trial and randomized to one of the following groups: * Group 1 receiving a single intravenous administration of cellular product on Day 0 and placebo infusion on day + 180. * Group 2 receiving a placebo infusion on day 0 and a single cell product administration on day +180. Randomization will be 1:1, so that 15 patients will receive the cellular product on Day 0 (Group 1) and 15 patients on day +180 (group 2), always maintaining at all times the double-blind status of the test (patients and researchers). The bone marrow will be extract from all patients immediately after inclusion in the study, under local anesthesia with sedation. For patients in group 1 autologous mesenchymal cells will be obtained from the bone marrow and infuse immediately after the time necessary for their production. For patients in group 2, bone marrow cells will be frozen for later procedure of mesenchymal cells and their infusion after six months. Patients will be evaluated by clinical, radiological, and electrophysiological as well as detailed in section 8 corresponding to Development Test and Evaluation of Response. It is estimated that the inclusion period is approximately 12-18 months, and each patient tracking another twelve months. Therefore the total duration of the study will be about 24 to 30 months from the inclusion of the first patient to completion follow-up period of the last patient included. Study objectives: * Main objectives: 1. To evaluate the safety of intravenous infusion of autologous bone marrow mesenchymal cells in multiple sclerosis patients diagnosed by evaluating complications and adverse effects of the therapy itself and study procedures. 2\. Assessing the difference in the number of lesions on magnetic resonance image with gadolinium, between the groups undergoing treatment at weeks 4, 12 and 24. * Secondary objectives: 1. To evaluate the feasibility and efficacy of the indication of the treatment by analysis comparative results and exploratory clinical variables of patients at baseline (pretreatment) and at 6 and 12 months follow-up. 2\. Compare the results of safety, feasibility and efficacy between the administration initial cell therapy treatment (day 0) and that delayed (day +180). 3\. Evaluating the immunomodulatory effect of treatment by quantifying cell subsets and cytokines, functional analysis of the immune response. Cerebrospinal fluid metabolomic profile of gene expression of the cells present in blood and cerebrospinal fluid, with the aim of identifying new biomarkers with diagnosis of interest, prognosis or monitoring, and potential therapeutic targets that can be derived from it. 4\. Providing our results to the study proposed by the International Mesenchymal Stem Cell Transplant Study Group under whose directives will be performed the test.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Bone marrow mesenchymal stem cells autologous	Infusion of mesenchymal cells from autologous bone marrow in a dose of 1-2x106 cells / kg
OTHER	Placebo comparator	Lactated Ringer's solution, 2.5% glucose and 1% human albumin.

Timeline

• Start date: 2013-01-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2012-12-10
• Last updated: 2022-04-06

Locations

3 sites across 1 country: Spain