Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of skin substitute reconstructed with cells isolated from patient biopsies
研究概览
简要总结
This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patient with chronic leg ulcers evolving for more than 6 months
- •Patient to receive skin pellet transplant
- •Chronic wound area between 10 and 30 cm²
排除标准
- •Patient without health insurance,
- •Pregnant womens,
- •Smoking patient,
- •Chronic wound area >30 cm²
研究组 & 干预措施
Skin graft pellet
This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies.
干预措施: Collection of supernumerary biopsies during skin graft pellet procedure (Procedure)
结局指标
主要结局
Number of skin substitute reconstructed with cells isolated from patient biopsies
时间窗: 1 year
次要结局
未报告次要终点