Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.

Study Overview
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Brief Summary
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Until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. We propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).

Detailed Description
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Multiple sclerosis (MS) is an autoimmune de-myelinating disease in which the myelin sheaths of nerve cells in the central nervous system are damaged.This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and psychiatric issues. To date, There is no known cure for multiple sclerosis. Treatments attempt to improve function after an attack and prevent new attacks. Stem cells possess strong immunomodulatory properties that are shown to play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and that may stimulate repair and regeneration of lesion. Clinical studies have shown that stem cells can be safely harvested and do not form tumors. Most of human stem cell trials have focused on clinical applications for haematopoietic stem cells (HSC), mesenchymal stem cells (MSC), or both. When administered intravenously they have an immune inhibitory effect that can ameliorate animal autoimmune diseases. MSC transplantation significantly improves clinical outcome in experimental allergic encephalitis (EAE). When administered intravenously, MSC may migrate to inflammatory brain lesions and promote survival of nervous cells. Hence, MSC have become the focus of studies as a potential cell therapy for stimulating neuro-protection in human neurodegenerative diseases such as MS. We propose a safety and efficacy trial of a intravenous and intrathecal injections of autologous bone marrow-derived stem cells into patients with MS.

Official Title
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Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Biological: Stem Cell Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsing-remitting MS (RRMS) patients Age 18-50 years Disease duration >= 2 and <= 10 years EDSS: 3.0 - 6.5 Exclusion Criteria: RRMS not fulfilling inclusion criteria SPMS or PPMSTreatment with any immunosuppressive therapy Treatment with interferon-beta or glatiramer acetate within the 30 days prior to transplantation Treatment with corticosteroids within the 30 days prior to transplantation Relapse occurred during the 60 days prior to transplantation History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C Pregnancy or risk of pregnancy/ lactation Current treatment with an investigational therapy Inability to give written informed consent in accordance with research ethics board guidelines

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cells<br>Intravenous administration of purified autologous bone marrow-derived stem cells. | Biological: Stem Cell Transplantation<br>* Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.<br>|
| Experimental: Stem Cell Transplantation<br>Intrathecal administration of purified autolgous bone-marrow derived stem cells. | Biological: Stem Cell Transplantation<br>* Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness assessment by MRI |  | 6 months | 
| Safety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life by Multiple Sclerosis Quality of Life (MSQOL-54) |  | 6 months | 
| Axonal effect by Optical coherence tomography (OCT) |  | 6 months | 
| Immunology: Dosing of G, A and M immunoglobulins, and complement factors C3 and C4 |  | 1 month |