Autologous Mesenchymal Stem Cells Transplantation for Spinal Cord Injury- A Phase I Clinical Study
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|ClinicalTrials.gov Identifier: NCT02482194|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : June 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Biological: mesenchymal stem cells||Phase 1|
The role of regenerative therapies has gained more importance due to increased number of SCI in the wake of recent anti-terrorism operations by the armed forces and non-availability of any curative treatment for this category of patients. The promising results of preliminary clinical trials have proved that adult stem cells especially multipotent mesenchymal stromal cells can be safely injected and well tolerated and have shown functional improvement in SCI patients. The successful treatment in these patients will not only improve functional status of these otherwise debilitating patients, but can also reduce the burden on health care facilities. Mesenchymal stem cells have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing, axonal regeneration, and remyelination. Therapeutic effects of MSCs are primarily due to the secretion of soluble factors and the provision of extracellular matrix that provide protection and support repair. MSC are attractive candidates for transplantation into human patients because they can be easily harvested, expanded and banked, or derived directly from the patient allowing for autologous transplantation, obviating the need for immune suppression. In this study patients suffering from sub-acute and chronic phase of spinal cord injury shall be included. Patients will undergo detailed screening through MRI and motor and sensory assessment by ASIA score. Further evaluation will include electromyography (EMG) and tests for electroneurophysiological assessment like nerve conduction velocity (NCV) will also be done. Bone marrow aspiration will be done from iliac crest of the patients, followed by mononuclear cells (MNCs) separation by density gradient centrifugation. MNCs will be washed and cultured in tissue culture flasks. After 48 hours non-adherent cells will be removed from culture. Medium will be changed twice weekly till MSCs reach 70-80 % confluence. At that point MSCs will be harvested and after microbiological and other quality control testing the cellular preparation will be diluted to final concentration and infused by intrathecal injection.
Primary outcome measure is safety which will be determined by clinical evaluation by two independent neurologists during one month of hospital stay after receiving treatment course.
Secondary outcome measures will include American Spinal Injury Association (ASIA) impairment scale and NCV/EMG.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells in Patients of Spinal Cord Injury-Phase I Clinical Trial|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Autologous mesenchymal stem cells
use of mesenchymal stem cells as therapeutic intervention for spinal cord injury patients by autologous transplantation
Biological: mesenchymal stem cells
autologous transplantation of mesenchymal stem cells in spinal cord injury patients
Other Name: MSC
- Number of adverse events [ Time Frame: 1 month ]Number of adverse events occurring in given time frame shall be reported to evaluate overall safety of the procedure
- Sensory and motor strength [ Time Frame: 1 year ]Improvement in sensitivity and motor strength will be measured through change in American Spinal Injury Association (ASIA) score from baseline
- Functional Independence [ Time Frame: 1 year ]Functional Independence will be measured by FIM scoring
- Muscle strength assessment [ Time Frame: 1 year ]Shall be done using Frankel scale
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): NCT02482194
|Armed Forces Bone Marrow Transplant Centre|
|Rawalpindi, Pakistan, 46000|
|Principal Investigator:||Parvez Ahmed||Commandant Armed Forces Bone Marrow Transplant Center|