Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule Following Resection of a Non Melanoma Skin Cancer- a Phase I Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- safety: post operative complications should not be at higher rate than gold standard operative procedure.
研究概览
简要总结
The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft, obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane, in the alar lobule of patients after resection of a non melanoma skin cancer.
详细描述
Skin cancer is the most prevalent reason for surgically creating a multilayer defect, consisting of skin and cartilage, of the alar lobule of the nose. In reconstruction of these defects, a combination of local flaps and autologous cartilage, typically harvested from the nasal septum or the ear, is used to restore the stability, function and proper 3D shape of the alar lobule. Harvesting autologous cartilage from the ear has been associated with a number of complications that could be overcome by the use of engineered cartilage graft generated in vitro with autologous cells.
This study is a phase I, prospective, uncontrolled, investigator initiated clinical trial involving 5 patients, with the objective of demonstrating safety and feasibility in the use of engineered nasal cartilage grafts. The specific surgical target of the trial is the reconstruction of a two layer defect of the alar lobule using a tissue engineered nasal cartilage graft and a local flap, following resection of a non melanoma skin cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •size of defect: ≥50% of alar subunit
- •Extent of defect: 2 layer defect: skin and fibro-cartilaginous tissues
排除标准
- •Defect extent:3 layers defect, including mucosa
- •defect extent: 1 layer defect
- •pregnancy
- •immunodeficiency HIV
- •Hepatitis B, C
- •Allergy to porcine collagen, penicillin or streptomycin
- •Chronic treatment with steroids or growth factors (immunomodulatory drugs)
结局指标
主要结局
safety: post operative complications should not be at higher rate than gold standard operative procedure.
时间窗: 12 months post reconstruction
Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side
次要结局
- feasibility of treatment(12 months post reconstruction)