Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01895439|
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : May 2, 2017
- 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.
- Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: MSCs injection
Autologous bone marrow derived stem cells injected intrathecally to enrolled MS patients
Biological: Autologous Mesenchymal Stem Cells
- The number of patients with any relevant side effects observed [ Time Frame: 18 months ]Assessing the safety of autologous Mesenchymal Stem Cells injection
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01895439
|Cell Therapy Center, Jordan University Hospital|
|Amman, Jordan, 11942|
|Study Director:||Abdallah Awidi, MD.||Cell Therapy Center|
|Principal Investigator:||Said Dahbour, MD.||Jordan University Hospital|