Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.

Official Title
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Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment

Conditions
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Autoimmune Diseases, Immune System Diseases, Demyelinating Diseases, Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System

Intervention / Treatment
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* Other: Autologous mesenchymal stem cells from adipose tissue.
* Other: Autologous mesenchymal stem cells from adipose tissue.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria). Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9. Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression. Patients with no MS relapse and no steroid treatment within the month prior to inclusion. Patients who give written consent to participate in the study. - Exclusion Criteria: History of current pathology or current laboratory results indicative of any severe disease. Pacemaker or metallic implants that prevent MR imaging. Inability to complete questionnaires. Refusal to give informed consent. Predicted impossibility for a biopsy of at least 30 grams of fat tissue. Positive screening test for HIV, Hepatitis B or Hepatitis C. History of malignancy. Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline. Body mass index> 40 kg/m2. Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study. Pregnancy or lactation -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose autologous mesenchymal cells<br>The dose of infused cells is 10e6 cells/Kg | Other: Autologous mesenchymal stem cells from adipose tissue.<br>* Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.<br>|
| Experimental: High dose<br>The dose of infused cells is 4*10e6 cells/Kg | Other: Autologous mesenchymal stem cells from adipose tissue.<br>* Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.<br>|
| No Intervention: Placebo Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells |  | 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Mesenchymal Stem Cells, Autologous