Status:
COMPLETED
Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment
Lead Sponsor:
University of Jordan
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice and study its efficacy when compared to a Supervised Physica...
Detailed Description
Umbilical cord derived MSCs bank will be generated and all patients given the same cells from the same biological sample. Thorough clinical, cognitive and motor analysis will be performed at baseline...
Eligibility Criteria
Inclusion
- A clinical diagnosis of definite MS according to the revised McDonald Criteria.
- Expanded Disability Status Scale (EDSS) ≤ 7
- 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 :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03326505
Start Date
September 25 2017
End Date
February 20 2020
Last Update
March 4 2020
Active Locations (2)
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1
Cell Therapy Center, University of Jordan
Amman, Jordan, 11942
2
Cell Therapy Center
Amman, Jordan, 11942