NCT02947191Unknown1 期
The Safety and Efficacy Assessment of Collagen Membrane Combined With Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Nasal Septum Perforation
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The change of integrity of nasal septum assessed by endoscopic examination
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in patients with chronic nasal septum perforation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
- •Male or female, 18-45 years old.
- •Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
排除标准
- •Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
- •Syphilis, leprosy, tuberculosis and other specific infections.
- •Severe Sinusitis.
- •Autoimmune diseases or long term treatment with corticosteroids.
- •Alzheimer's disease.
- •Systemic diseases (e.g.,hypertension, diabetes and so on).
- •Previous history of nasal cancer or after receiving radiotherapy.
- •Drug abuse.
- •History of mental illness.
结局指标
主要结局
The change of integrity of nasal septum assessed by endoscopic examination
时间窗: baseline, 1,2,3,4,8,12 weeks after surgery
次要结局
- The change of nasal obstructive symptom assessed by visual analogue scale (VAS)(baseline, 12 weeks after surgery)
- The change of nasal symptom severity assessed by total nasal symptom score (TNSS)(baseline, 12 weeks after surgery)
- The change of nasal mucosal physiology assessed by nasal mucociliary clearance time (MCT)(baseline, 12 weeks after surgery)
- The change of nasal airway resistance assessed by rhinomanometry(baseline, 12 weeks after surgery)
- The change of nasal obstruction assessed by acoustic rhinometry(baseline, 12 weeks after surgery)
- Change from baseline in computed tomography (CT)(baseline, 12 weeks after surgery)
- The change of nasal mucosal physiology assessed by olfactory test(baseline, 12 weeks 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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