Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Occurence of major adverse events
研究概览
简要总结
The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges
详细描述
In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.
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
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.
排除标准
- •evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration
- •history of delayed healing, radiational therapy;
- •significant renal, cardiovascular, hepatic and psychiatric diseases;
- •significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
- •BMI >30;
- •history of any hematological disease, including leukopenia, thrombocytopenia, or thrombocytosis;
- •Evidence of malignant diseases
- •unwillingness to participate.
研究组 & 干预措施
tissue/ organ prefabrication
in vivo generation of autologous tissue for joint replacement
干预措施: tissue/ organ prefabrication (Procedure)
结局指标
主要结局
Occurence of major adverse events
时间窗: through study completion 12 months after prefabrication
Including infection, necrosis, resorption
次要结局
- Feasibility of self-prefabrication(3, 6, and 12 months after prefabrication)
研究者
Qing-Feng Li
MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital Affiliation: Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine