Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- functional recovery : sensory recovery
研究概览
简要总结
In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems.
By proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like English and American teams, considering the possibility of total facial surface reconstruction.
In parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach.
Five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with loss of unrepairable substance by conventional techniques shreds, at the front
排除标准
- •Facial lesions repaired by conventional reconstructive surgery techniques
- •History of malignancy in remission for less than 5 years
- •Malignant neoplasm undergoing changes
- •Severe psychiatric history
- •Patients above a score of 2 on the scale of the ASA (American Society of Anesthesiology)
- •Patients above a grade 1 in the classification NYHA ( New York Heart Association )
- •insufficient with renal creatinine clearance less than 70 mL / min or presence of a proteinuria
- •Severe hypertension
研究组 & 干预措施
Composite tissue allotransplantation
干预措施: composite tissue allotransplantation (Procedure)
结局指标
主要结局
functional recovery : sensory recovery
时间窗: 1 year
Sensitivity to light touch, as assessed with the use of static monofilaments
functional recovery : motor recovery
时间窗: 1 year
labial contact allowing complete mouth closure
次要结局
- functional recovery : motor recovery(2 years, 5 years)
- functional recovery : sensory recovery(2 years, 5 years)
