Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis

Study Overview
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Brief Summary
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Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment. Assessing the therapeutic benefits on the participants in the trial as per established methods.

Official Title
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Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Biological: Autologous Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical diagnosis of definite MS according to the revised McDonald Criteria. Expanded Disability Status Scale (EDSS) ≤ 6 Failure of standard medical therapy Disease duration of at least three years prior to enrollment. Exclusion Criteria: Pregnant and lactating women Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment Recent MS relapse in the month prior to enrollment Treatment with oral or parenteral steroids for any cause in the month prior to enrollment Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast. Positive serology for HIV, Hepatitis B or Hepatitis C Any history of malignancy or exposure to radiation at any time prior to enrollment Any contra-indication to lumbar puncture Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSCs injection<br>Autologous bone marrow derived stem cells injected intrathecally to enrolled MS patients | Biological: Autologous Mesenchymal Stem Cells<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with any relevant side effects observed | Assessing the safety of autologous Mesenchymal Stem Cells injection | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests. | For every patient tests would be performed at baseline and repeated at 3, 6, and 18 months post-injection | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuroimmunology, Autoimmune disease, Bone marrow derived Mesenchymal Stem Cells, Multiple Sclerosis, Oligodendrocytes