Status:
COMPLETED
Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis
Lead Sponsor:
University of Jordan
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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. Ass...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01895439
Start Date
October 1 2012
End Date
February 1 2016
Last Update
May 2 2017
Active Locations (1)
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1
Cell Therapy Center, Jordan University Hospital
Amman, Jordan, 11942