Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis
This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal
stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.
Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6,
the treatment will be crossed to receive the other product. The objective is to assess the
safety of a single infusion BM-MSC, and to explore its efficacy in these patients.
Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.
To date, there is no effective therapy to cure multiple sclerosis (MS). Immunomodulatory therapies are useful in reducing the frequency of inflammatory processes (relapses) but don't delay significantly the progression of the disease, prevent long term disability or induce the repair of damaged tissue. This proposal contemplates the use of adult autologous bone marrow mesenchymal stromal cells (BM-MSC) as an alternative therapeutic strategy to treat patients with active MS. This is a randomized, double blind, crossover clinical trial in which 8 patients with active forms of MS and moderate disability will enter the trial with the primary objective of assessing the safety and tolerability of a single intravenous infusion of BM-MSC. Secondary objectives are to assess the efficacy by gadolinium enhancing lesions though magnetic resonance imaging, neurophysiological effects and immunological effects. Once randomized, patients will undergo BM extraction and once confirmed the availability of the needed dose, they will be randomized to one of the 2 treatment arms (BM-MSC named XCEL-MC-ALPHA, or placebo). XCEL-MC-ALPHA will be cryopreserved for all patients regardless the allocated arm. At month 6, the treatment will be crossed. Patients will be evaluated at month 12 and will be followed-up for a total of 3 years. ;
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