Ignite Creation Date:
2024-05-05 @ 10:36 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01140087
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2010-06-07
Brief Title:
Face Transplantation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Maxillofacial Composite Tissue Allograft Transplantation Face Transplant
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to
1 Perform face transplants on people who have suffered severe facial trauma with tissue and functional loss and
2 Evaluate the acceptance and function of the transplanted tissue
1 Perform face transplants on people who have suffered severe facial trauma with tissue and functional loss and
2 Evaluate the acceptance and function of the transplanted tissue
Detailed Description:
For patients with severe facial deformities or facial wounds from traumatic injuries we would like to pursue the use of a face transplant to help reconstruct a persons damaged face Our goal is to not only give the patient back a normal appearance to their face but also the functioning movement and sensation of their face including that of the lips mouth and eyes For some patients with severe face deformities simple tasks such as smiling talking eating kissing a loved one or even just being able to contain their saliva become difficult if not impossible These patients often become depressed because of their facial deformities
Although there are some techniques in plastic and reconstructive surgery that can repair the look of a patients face often these cannot replace the moving parts of the face Currently patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues called autologous transplant This surgery often leaves unacceptable scars and deformities of the patients donor sites Also this conventional reconstruction method requires many returns to the operating room to carefully form and shape the transplanted free flap Lastly this type of reconstruction is still limited as it does not provide a reliable return in function sensation and appearance for the damaged parts of the face
Instead if we use a composite tissue allograft CTA or face transplant from a donor who is brain dead such as in heart kidney and liver transplants we could replace the damaged parts of the face with the same missing parts that could return movement as well However since the transplanted facial tissues are from another person these face transplant recipients need medicines that would keep their body from rejecting the new tissues This new course of medicines would be their daily responsibility Though there are risks with taking these medicines the risks have been lowered by many prior studies that have been done with patients who have had other organ transplants However the risks are still a consideration when deciding to choose this option for correcting severe facial deformities
This study aims to perform a face transplant on a person who has suffered a severe facial trauma with tissue and functional loss and with limited other established surgical options to repair their deformities We will conduct the surgery and prospectively follow the patient to monitor his or her clinical and functional outcomes and ensure that optimal results are achieved We will systematically document and record the entire process of the patients surgery and recovery An important factor of this surgerys success is that the patient strictly follows and takes the required course of medicines to prevent rejection of the donor tissues In order to ensure that the tissue survives and is not rejected by the patient we will continuously check various clinical values such as blood work tissue samples and x-ray images
We would like to offer facial segment transplantation as a reconstructive option to patients with severe facial deformities We feel facial transplantation has now become a viable option for certain patients If successful this will contribute to future research and development in the field of tissue transplantation Most importantly our goal is to offer patients the best option in reconstruction to restore both form and function who otherwise do not have another option
Although there are some techniques in plastic and reconstructive surgery that can repair the look of a patients face often these cannot replace the moving parts of the face Currently patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues called autologous transplant This surgery often leaves unacceptable scars and deformities of the patients donor sites Also this conventional reconstruction method requires many returns to the operating room to carefully form and shape the transplanted free flap Lastly this type of reconstruction is still limited as it does not provide a reliable return in function sensation and appearance for the damaged parts of the face
Instead if we use a composite tissue allograft CTA or face transplant from a donor who is brain dead such as in heart kidney and liver transplants we could replace the damaged parts of the face with the same missing parts that could return movement as well However since the transplanted facial tissues are from another person these face transplant recipients need medicines that would keep their body from rejecting the new tissues This new course of medicines would be their daily responsibility Though there are risks with taking these medicines the risks have been lowered by many prior studies that have been done with patients who have had other organ transplants However the risks are still a consideration when deciding to choose this option for correcting severe facial deformities
This study aims to perform a face transplant on a person who has suffered a severe facial trauma with tissue and functional loss and with limited other established surgical options to repair their deformities We will conduct the surgery and prospectively follow the patient to monitor his or her clinical and functional outcomes and ensure that optimal results are achieved We will systematically document and record the entire process of the patients surgery and recovery An important factor of this surgerys success is that the patient strictly follows and takes the required course of medicines to prevent rejection of the donor tissues In order to ensure that the tissue survives and is not rejected by the patient we will continuously check various clinical values such as blood work tissue samples and x-ray images
We would like to offer facial segment transplantation as a reconstructive option to patients with severe facial deformities We feel facial transplantation has now become a viable option for certain patients If successful this will contribute to future research and development in the field of tissue transplantation Most importantly our goal is to offer patients the best option in reconstruction to restore both form and function who otherwise do not have another option
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N00014-07-1-0298 | OTHER_GRANT | ONR | None |