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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03069170 |
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Date of registration:
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25/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.
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Scientific title:
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Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis. |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03069170 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Adeeb AlZoubi, PhD |
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Address:
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Telephone:
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00962795337575 |
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Email:
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adeebalzoubi@stemcellsarabia.net |
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Affiliation:
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Name:
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Adeeb AlZoubi, PhD |
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Address:
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Telephone:
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00962795337575 |
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Email:
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adeebalzoubi@stemcellsarabia.net |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Biological: Stem Cell Transplantation
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Primary Outcome(s)
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Safety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS)
[Time Frame: 12 months]
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Effectiveness assessment by MRI
[Time Frame: 6 months]
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Secondary Outcome(s)
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Immunology: Dosing of G, A and M immunoglobulins, and complement factors C3 and C4
[Time Frame: 1 month]
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Axonal effect by Optical coherence tomography (OCT)
[Time Frame: 6 months]
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Change in Quality of life by Multiple Sclerosis Quality of Life (MSQOL-54)
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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