Human Composite Facial Allotransplantation

Methodist Health System1 个研究点分布在 1 个国家目标入组 3 人2014年10月21日

适应症Transplantation: Facial Transplantation

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Transplantation: Facial Transplantation
发起方: Methodist Health System
入组人数: 3
试验地点: 1
主要终点: Facial Disability Index
状态: 已完成
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Allotransplantation of maxillofacial of subject with severe facial deformities due to traumatic events.

详细描述

A facial transplantation is a highly dynamic, prolonged operation requiring teams communicating seamlessly through its duration. This is similar to complex solid organ transplant teams at Methodist Transplant Institute. The Institute's clinical experience in management of complex facial defects and deformities along with the personnel and infrastructure at Methodist Dallas transplant institute would help develop a center for Facial Allotransplantation. The team experience, true collaboration, creativity and a unique approach to each patient would help provide the optimal care and reconstruction for the face allotransplant patient both before and after surgery. The purpose of this study is centered on the advancement of a safe and effective procedure for Facial Allotransplantation at Methodist Hospital Medical Center at Dallas. Composite tissue allotransplantation for facial reconstruction is in its infancy as liver transplantation was 30 years ago when the first liver transplant was completed in Texas. This study will establish Methodist Hospital System as a center for Facial Allotransplantation for reconstruction of extensive facial defects resulting in functional loss and poor quality of life. Patient participation post transplantation will either be for life, or failure of the composite tissue allograft. Patient enrollment will be initiated immediately after the IRB approval. The enrollment period will be completed after the patient receives the final transplant, and the study will be completed at 24 months after the final transplant. However, all patients enrolled into the study will have lifelong follow up with immunosuppressive management, psychological support, and evaluation of functional recovery per protocol.

注册库

clinicaltrials.gov

开始日期

2014年10月21日

结束日期

2021年3月18日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Methodist Health System

责任方

Sponsor

入排标准

入选标准

•Between ages 18-70 years
•Must be willing to undergo major facial reconstruction
•Be able to understand the pre and post-transplantation evaluation, physical therapy, and follow up procedures
•Conventional reconstruction deemed unsatisfactory

排除标准

•Medically unable to provide consent
•Active infections such as Human Immunodeficiency Virus, mycobacteria, hepatitis B, and hepatitis C
•Recent history of alcohol or IV drug or chemical dependency
•Psychiatric evaluation that indicate mental instability or non-compliance
•Cognitively impaired and Terminally ill
•Women of child bearing age with intent to conceive, pregnant or lactating
•Unable to receive immunosuppression after transplantation because of either geographic or financial limitations
•End stage organ disease (renal failure, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), etc.)
•Chronic infections such as osteomyelitis

结局指标

主要结局

Facial Disability Index

时间窗: measured at 24 months

a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders

Modified Facial Clinimetric Evaluation Scale

时间窗: measured at 24 months