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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03069170
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : June 6, 2018
Information provided by (Responsible Party):
Stem Cells Arabia

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Stem Cell Transplantation Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.
Study Start Date : July 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Stem Cells
Intravenous administration of purified autologous bone marrow-derived stem cells.
Biological: Stem Cell Transplantation
Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.

Experimental: Stem Cell Transplantation
Intrathecal administration of purified autolgous bone-marrow derived stem cells.
Biological: Stem Cell Transplantation
Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.

Primary Outcome Measures :
  1. Effectiveness assessment by MRI [ Time Frame: 6 months ]
  2. Safety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS) [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03069170

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Stem Cells Arabia
Amman, Jordan, 11953
Sponsors and Collaborators
Stem Cells Arabia

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Responsible Party: Stem Cells Arabia Identifier: NCT03069170    
Other Study ID Numbers: SCA-MS1
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases