NCT02767817Unknown1 期
The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of adverse events and participants with those adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female，35-75 years old.
- •The surgery time should be > 6 hours after symptom onset.
- •Glasgow coma score (GCS) was 9-
- •CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma.
- •Signed informed consent obtained from the patient or patient's legally authorized representative.
排除标准
- •Glasgow coma scale of <
- •Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela.
- •Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization.
- •Lactating or pregnant woman.
- •Refuse to sign informed content.
结局指标
主要结局
Number of adverse events and participants with those adverse events
时间窗: 24 month
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
次要结局
- Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP)(baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery)
- Change in electrical brain activity as measured by Electroencephalography (EEG)(baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 24 month after surgery)
- Change in brain pathology diagnosed by Head CT scan(baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery)
- Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score(baseline, day 1-7, and 1, 3, 6, 12, 18 and 24 month after surgery)
- Change in motor recovery evaluated by Brunnstrom stage(1, 3, 6, 12, 18 and 24 month after surgery)
- Change in pain intensity as measured by Visual Analogue Scale (VAS)(1, 3, 6, 12, 18 and 24 month after surgery)
- Change in self-care ability as measured by Barthel Index (BI)(1, 3, 6, 12, 18 and 24 month after surgery)
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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