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Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Facies
  • Transplantation: Facial Transplantation

NCT number NCT05117190
Study type Interventional
Source Methodist Health System
Contact Crystee Cooper, DHEd
Phone 214-947-1280
Email [email protected]
Status Recruiting
Phase N/A
Start date October 2014
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT01140087 - Face Transplantation N/A