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Trial record 1 of 1 for:    NCT01895439
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Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in 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: NCT01895439
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

Brief Summary:
  1. 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.
  2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
  3. Assessing the therapeutic benefits on the participants in the trial as per established methods.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Autologous Mesenchymal Stem Cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment
Study Start Date : October 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MSCs injection
Autologous bone marrow derived stem cells injected intrathecally to enrolled MS patients
Biological: Autologous Mesenchymal Stem Cells

Primary Outcome Measures :
  1. The number of patients with any relevant side effects observed [ Time Frame: 18 months ]
    Assessing the safety of autologous Mesenchymal Stem Cells injection

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT01895439

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Cell Therapy Center, Jordan University Hospital
Amman, Jordan, 11942
Sponsors and Collaborators
University of Jordan
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Study Director: Abdallah Awidi, MD. Cell Therapy Center
Principal Investigator: Said Dahbour, MD. Jordan University Hospital

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Responsible Party: Fatima Jamali, Researcher, University of Jordan Identifier: NCT01895439     History of Changes
Other Study ID Numbers: MSUJCTC
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Keywords provided by Fatima Jamali, University of Jordan:
Bone marrow derived Mesenchymal Stem Cells
Multiple Sclerosis
Autoimmune disease
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