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

Stem Cells Arabia

Status and phase: Unknown; Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03069170

SCA-MS1

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Stem Cells

Experimental group

Description:

Intravenous administration of purified autologous bone marrow-derived stem cells.

Treatment:

Biological: Stem Cell Transplantation

Stem Cell Transplantation

Experimental group

Description:

Intrathecal administration of purified autolgous bone-marrow derived stem cells.

Treatment:

Biological: Stem Cell Transplantation