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Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and neurological deficits in injured individuals. The limited ability of the Central Nervous System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated accidents, falls, and violence-related injuries.
Unfortunately, there is still no effective clinical treatment for SCI. In recent years, tissue engineering and regenerative medicine based approaches have been proposed as alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed promising results in several studies. Our aim is to assess and compare the safety and effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.
The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal numbers. The first groups will be treated with autologous BM-MSC, while the second group will be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging (MRI) will be performed at base line and after 12 months of the stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipient of AT-MSC | Active Comparator | Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times. |
|
| Recipient of BM-MSC | Active Comparator | Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Mesenchymal Stem Cells | Biological | Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC. | Comparing the number of SCI patients with any relevant side effects observed and the measured outcome in each arm by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigating the number of side effects in SCI patients receiving autologous BM-MSC. | Assessing the number of SCI patients with any relevant side effects observed. | 12 months |
| Investigating the effectiveness of autologous BM-MSC in treating SCI patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdalla Awidi, MD | University of Jordan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cell Therapy Center, University of Jordan | Amman | 11942 | Jordan |
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| Label | URL |
|---|---|
| Cell Therapy Center Website | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Assessing the therapeutic benefits of the injected Autologous BM-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system. |
| 12 months |
| Investigating the number of side effects in SCI patients receiving autologous AT-MSC. | Assessing the number of SCI patients with any relevant side effects observed. | 12 months |
| Investigating the effectiveness of autologous AT-MSC in treating SCI patients. | Assessing the therapeutic benefits of the injected Autologous AT-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system. | 12 months |
| D014947 | Wounds and Injuries |