NCT02688062Unknown1 期
NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Improvements in ASIA (American Spinal Injury Association) Impairment Scale
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.
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
- Double (Participant, Outcomes Assessor)
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
- •Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology.
- •ASIA Impairment Scale (AIS) grade A.
- •Male or female, 18-60 years old.
- •No significant further improvement after injury and rehabilitation.
- •Patients with normal peripheral nerve function and without muscle atrophy.
- •Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges.
- •No brain disease or mental disorder.
- •Ability and willingness to regular visit to hospital and follow up during the protocol procedures.
- •Patients signed informed consent.
排除标准
- •A current diagnosis of any primary diseases affecting limb functions (e.g., traumatic brain injury, cerebral hemorrhage, cognitive disorders or other central nervous system diseases).
- •Patients without any rehabilitation train after injury.
- •Remarkable muscle atrophy or fibrosis.
- •Degeneration of peripheral nerve function.
- •Allergic constitution.
- •Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study.
- •Suffering diabetes, autoimmune diseases, tumor or severe hypertension.
- •Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards.
- •Severe bleeding tendency or abnormal coagulation function.
- •Inflammation or skin ulcers at the surgical site.
- •Lactating and pregnant woman.
- •Poor compliance, difficult to complete the study.
- •Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
结局指标
主要结局
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
时间窗: 24 months
Improvements in Somatosensory Evoked Potentials (SSEP)
时间窗: 24 months
Improvements in Motor Evoked Potentials (MEP)
时间窗: 24 months
次要结局
- Magnetic Resonance Imaging (MRI)(1, 3, 6, 12, 18 and 24 months)
- Improvements in Urinary and Bowel Function(1, 3, 6, 12, 18 and 24 months)
- Safety and Tolerability assessed by Adverse Events(Up to 6 months)
- Improvements in Independence Measures(1, 3, 6, 12, 18 and 24 months)
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 (2)
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