Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01140087 |
| Other study ID # |
HP-00040219 |
| Secondary ID |
N00014-07-1-0298 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2010 |
| Est. completion date |
August 14, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 person's 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 patient's 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 patient's 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 patient's
surgery and recovery. An important factor of this surgery's 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.
