The Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 主要终点
- Wound healing evaluation
研究概览
简要总结
Nasal trauma, deviated nasal septum, sinusitis, nasal polyps and other nasal benign diseases are common clinical diseases and require endoscopic sinus surgery. The proper application of the surgical procedure as well as ensuring high quality of wound healing, is also important to achieve successful results in endoscopic sinus surgery. If good quality wound healing cannot be achieved in the surgical field,synechiae and anatomic defects can occur that may require revision surgeries.
Mesenchymal stem cells play an active role in the treatment of many diseases. it primarily exerts therapeutic effects through paracrine. In this study, the effect of mesenchymal stem cell-derived multipotent factors on mucosal repair after nasal surgery was evaluated.
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
- 是
入选标准
- •18 to 60 years old;
- •The clinical diagnosis is nasal trauma, nasal septum deviation, sinusitis, and nasal polyps requiring endoscopic surgery;
- •The patient's physical and mental state is stable, and he can return to the hospital regularly for follow-up examinations and cooperate to complete the experiment;
排除标准
- •Younger than 18 or older than 60;
- •Clinical diagnosis of nasal malignancies, or uncontrolled severe infectious diseases;
- •Past medical history of mental illness, malignant tumor, nose surgery;
- •People with serious underlying diseases (hypertension, diabetes, rheumatism, asthma) require long-term medication;
- •Long-term smoking, more than 5 cigarettes per day;
- •Work or daily life environment is exposed to large amounts of dust and chemical raw materials;
结局指标
主要结局
Wound healing evaluation
时间窗: 2 months
Lund-Kennedy scoring method；under video nasal endoscopy. Including five aspects of polyps, edema, rhinorrhea, scars, and scabs, each score is 0-2 points. Polyp: 0 points means no polyps, 1 point means polyps only in the middle nasal passage, 2 points means polyps beyond the middle nasal passage. Edema: 0 points means no edema, 1 point means mild edema, 2 points means severe edema. Rhinorrhea: 0 points means no rhinorrhea, 1 point means clear and thin nose, 2 points means rhinorrhea is sticky and purulent. Scar: 0 points means no scars, 1 points means mild scars, 2 points means severe scars. Scab formation: 0 points means no scab formation, 1 point means mild scab formation, and 2 points means severe scab formation. Each side 0-10 points, a total of 20 points, the lower the score indicates that the patient's symptoms are lighter.
次要结局
未报告次要终点
研究者
Xiaobing Fu
Professor
Chinese PLA General Hospital