Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- SCI evaluation and patients follow up
研究概览
简要总结
This study aims to assess and compare the safety and effectiveness of Autologous Bone Marrow-Derived MSCs (AutoBM-MSCs) in one group(group A) of SCI who are unlikely to be able to walk independently without treatment after 1 year of SCI, in the other group (group B) to assess the second group of Wharton Jelly derived mesenchymal stem cells ( WJ-MSCs) in the treatment of acute and subacute spinal cord injury (SCI) patients.
详细描述
The study will be directed by the Cell Therapy Center (CTC) in Jordan, where 20 SCI patients meeting the inclusion criteria will be recruited and divided according to the type of injury into two groups; Group A for patients with complete transection of the spinal cord, and Group B for SCI without a total transaction,10 patients will receive (AutoBM-MSCs)and the other 10 patients with acute and subacute spinal cord injury will receive(WJ-MSCs) by a specialized spine surgeon into the spinal medulla. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and the Spinal Cord Independence Measure (SCIM) version III, in addition to blood tests, MRI, and somatosensory evoked potential (SSEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age: 18-70 years
- •Complete SCI grade AIS-A or -B, or incomplete C
- •SCI between cervical levels C5 and thoracic level T11
- •At least 12 weeks since time of injury
- •Prediction rule score of 10 or less
- •Cognitively unaffected
- •Motivated for stem cell transplantation
排除标准
- •Reduced cognition
- •Age under 18 years or 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 HIV, HBV, 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 MRI.
- •Other medical conditions which can interfere with stem cell transplantation
- •Inability to provide informed consent.
- •Uncorrected vision
- •Cardiac abnormalities and uncontrolled hypertension
结局指标
主要结局
SCI evaluation and patients follow up
时间窗: 3 months
the (ASIA)/(ISNCSCI) to evaluate any motor or neurological changes, and the spinal cord independence measure (SCIM III) score to evaluate the effect on daily activities .these tests will be repeated every 3 months. blood samples will be withdrawn from patients as well to detect any biomarkers.
SCI evaluation and MSCs transplantation
时间窗: 6-12 months
post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
次要结局
未报告次要终点
研究者
Fatima Jamali
Head of Neuroscience Research
University of Jordan