NCT03966794Unknown1 期
Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety and Tolerability assessed by Adverse Events
研究概览
简要总结
The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The enrolled participants are divided into three categories:
- •Participants had complete functional scaffold transplantation in previous study and had motor functional recovery
- •Participants With Acute Complete SCI: (1) Classification ASIA A, occurring within past 14 days; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) No serious complications
- •Participants With Chronic Complete SCI: (1) Classification ASIA A, greater than 6 months post injury and no significant further improvement within past 3 months; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) Peripheral nervous system in good condition; (4) No serious complications
- •Inclusion Criteria For All The Participants
- •Men or non-pregnant women, 18-60 years old
- •Ability and willingness to regular visit to hospital and follow up during the protocol Procedures
- •Accompanied by a family member
- •Signed informed consent
排除标准
- •Obvious muscle atrophy or fibrosis
- •Decline in peripheral nerve function
- •A current diagnosis of diseases affecting spinal cord injury recovery or rehabilitation training (e.g., brain injury, cerebral hemorrhage, cognitive impairment, other central nervous system diseases)
- •Having serious health problems, (e.g., cardiovascular disease, diabetes, autoimmune diseases, tumors or severe hypertension) or serious complications (e.g. severe bedsores, pulmonary infection, respiratory disorders)
- •Pregnancy or lactation
- •History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders
- •No family member accompany or can not get in touch with family members
- •Poor compliance, difficult to complete the study
- •Any other conditions that might increase the risk of participants or interfere with the clinical trial
研究组 & 干预措施
Epidural Electrical Stimulation
Experimental
干预措施: Epidural Electrical Stimulation (Device)
Functional scaffold & Epidural Electrical Stimulation
Experimental
干预措施: Functional scaffold & Epidural Electrical Stimulation (Combination Product)
结局指标
主要结局
Safety and Tolerability assessed by Adverse Events
时间窗: Up to 6 months
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up
Change in ASIA Impairment Scale
时间窗: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation.
次要结局
- Change in ASIA motor score(Baseline, 1, 3 , 6, 12 and 24 months post-treatment)
- Change in Functional Independence Measure (FIM)(Baseline, 1, 3 , 6, 12 and 24 months post-treatment)
- Change in Walking Speed(Baseline, 1, 3 , 6, 12 and 24 months post-treatment)
- Change in Somatosensory Evoked Potentials (SSEP) monitoring(Baseline, 1, 3 , 6, 12 and 24 months post-treatment)
- Change in Motor Evoked Potentials (MEP) monitoring(Baseline, 1, 3 , 6, 12 and 24 months post-treatment)
- Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)(Baseline, 1, 3 , 6, 12 and 24 months post-treatment)
- Change in Stride length(Baseline, 1, 3 , 6, 12 and 24 months post-treatment)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences
研究点 (1)
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