| Eligibility |
Inclusion Criteria:
- Recent (=6 months) or remote (i.e., several decades) severe facial disfigurement
and/or facial functional impairment covering at least 25% of face and/or a major part
e.g. nose, lips and desiring face transplantation.
- Aged 18-65 years. Noted should be that the maximal age difference between donor and
recipient will be 10 years.
- Completion of the protocol informed consent form.
- No co-existing medical condition which, in the opinion of the study team, could affect
the immunomodulatory protocol, surgical procedure, or functional results (see Donor
and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the
study team must agree that said condition should not significantly enhance the
surgical risks of facial transplantation.)
- No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
- Negative for malignancy for past 5 years.
- Negative for HIV at transplant.
- Negative crossmatch with donor.
- If female of child-bearing potential, negative serum pregnancy test. If female of
child-bearing potential, consent to use reliable contraception for at least one year
following transplantation.
- Patient agrees to comply with the protocol and states a dedication to the
immunomodulatory treatment regimen.
- No smoking for 6 months prior to transplant, as confirmed by blood testing.
Exclusion Criteria:
- Positive for any of the following conditions: Untreated sepsis, HIV (active or
seropositive), active tuberculosis, hepatitis B or C (HCV Ab+ and HCV RNA+ (HCV Ab+
but RNA negative is acceptable), HBVcAb+, HBVsAg+ or viral DNA+), viral encephalitis,
toxoplasmosis, malignancy (within past 5 years), current/recent (within months of
donation/consent) IV drug abuse, paralysis of ischemic or traumatic origin, inherited
peripheral neuropathy, infectious, post infectious, or inflammatory (axonal or
demyelinating) neuropathy, toxic neuropathy (i.e. heavy metal poisoning, drug
toxicity, industrial agent exposure), mixed connective tissue disease, severe
deforming rheumatoid or osteoarthritis in the limb.
- Conditions that, in the opinion of the study team, may impact the immunomodulatory
protocol potentially exposing the recipient to an unacceptable risk under
immunosuppressive treatment, including all liver and renal disease.
- Sensitized recipients with high levels (>=50%) of panel-reactive HLA antibodies.
- Conditions that may impact the success of the surgical procedure or increase the risk
of postoperative complications including inherited coagulopathies like Hemophilia,
Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias,
Sickle Cell disease, etc.
- Mixed connective tissue diseases and collagen diseases can result in poor wound
healing after surgery.
- Conditions that may impact functional outcomes including lipopolysaccharidosis and
amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like
osteopetrosis.
- Pregnant, breastfeeding or planning to become pregnant within the next 2 years.
- Unable or unwilling to use an acceptable birth control method for 2 years following
transplant. The patient cannot have given birth in the past 2 years. We acknowledge
that a female recipient of childbearing age must carefully consider the associated
risks of the transplant and immunosuppression and personally prioritize these issues
and the lead face transplant surgeon (Dr. Cetrulo) will implement this subject in the
preoperative education of the patient during consultation.
- Patients will be required to stop smoking for 6 months prior to listing and abstain
from postoperative smoking
- If a subject does not receive a transplant after one year of enrollment, clinical
consent will be re-obtained from that subject and clinical consent will be re-obtained
yearly while the subject is enrolled and waiting for a donor.
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