NCT02045745Unknown1 期
CLINICAL TRIAL PHASE I / II, PROSPECTIVE, OPEN, NONRANDOMIZED, FOR TREATMENT OF POSTOPERATIVE AIR LEAK AFTER LUNG RESECTION IN HIGH RISK PATIENTS THROUGH THE ADMINISTRATION OF MESENCHYMAL AUTOLOGOUS CELLS.
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of the procedure
研究概览
简要总结
The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded)
- •Patients class C or D on the risk scale of air leak Patients included in the study must meet all inclusion criteria.
排除标准
- •Patients with any of the following exclusion criteria may not be included in the clinical trial:
- •Those considered by the investigator are not on a good position to tolerate the procedure
- •Clinical criteria and anesthetics that contraindicate surgery
- •Uncontrolled severe disease
- •Pregnant women
- •Patients infected with hepatitis B, hepatitis C, syphilis and HIV + virus
- •People who are taking a drug under clinical investigation or participated in any study under clinical investigation (or an authorized product) within 30 days prior to randomization
- •The absence of informed consent or revocation thereof
结局指标
主要结局
Safety of the procedure
时间窗: During the procedure and postoperative period (48 hours)
Security is measured in terms of: Adverse effects derived from the implantation of the CSM
次要结局
- Analyze the efficacy of the procedure(Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months)
研究者
研究点 (2)
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