Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Evaluation of Safety and Effectiveness of Autologous Bone Marrow Derived Mesenchymal Stem Cells (BM-MSC) vs Adipose Tissue Derived Mesenchymal Stem Cells (AT-MSC) in the Treatment of Spinal Cord Injury (SCI) Patient.

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Biological: Autologous Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete spinal cord injury grade AIS-A or -B, or incomplete C At least 2 weeks since time of injury Cognitively unaffected Motivated for stem cell transplantation Exclusion Criteria: Reduced cognition Age under 18 years of above 70 years Significant osteoporosis in spine and/or joints Pregnancy (Adequate contraceptive use is required for women in fertile age) Anoxic brain injury Neurodegenerative diseases Evidence of meningitis Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Syphilis. Medical Complications that contraindicate surgery, including major respiratory complications. Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate Magnetic resonance imaging (MRI). Other medical conditions which can interfere with stem cell transplantation Inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recipient of AT-MSC<br>Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times. | Biological: Autologous Mesenchymal Stem Cells<br>* Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.<br>|
| Active Comparator: Recipient of BM-MSC<br>Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times. | Biological: Autologous Mesenchymal Stem Cells<br>* Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Mesenchymal Stem Cells