跳至主要内容
临床试验/NCT02818400
NCT02818400招募中不适用

Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2009年11月最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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