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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Recipient of AT-MSC
Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times.
干预措施: Autologous Mesenchymal Stem Cells (Biological)
Recipient of BM-MSC
Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times.
干预措施: Autologous Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
时间窗: 12 months
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..
次要结局
- Investigating the number of side effects in SCI patients receiving autologous BM-MSC.(12 months)
- Investigating the effectiveness of autologous BM-MSC in treating SCI patients.(12 months)
- Investigating the effectiveness of autologous AT-MSC in treating SCI patients.(12 months)
- Investigating the number of side effects in SCI patients receiving autologous AT-MSC.(12 months)
研究者
Fatima Jamali
Principal Investigator
University of Jordan