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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.
Cell Therapy Center, University of Jordan
Amman, Jordan
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..
Time frame: 12 months
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.
Time frame: 12 months
Investigating the effectiveness of autologous BM-MSC in treating SCI patients.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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