💬In plain words
What the trial is, and whether it could suit you
Background: The human face is critically important for breathing, eating, seeing, and speaking/ communicating, but its most important job may be to look like a human face. Devastating facial deformities often cause affected individuals to avoid human contact and disappear from society. Although current surgical advancements can somewhat restore facial defects, this process often requires many operations and the resulting face only resembles the human face. To date, over 20 face transplants have been performed with highly encouraging functional and aesthetic results, but widespread clinical use has been limited due to the adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Recent (≥6 months) or remote (i.e., several decades) craniomaxillofacial injury
* Male or female and of any race, color, or ethnicity.
* Aged 18-65 years.
* Strong desire to undergo craniomaxillofacial transplantation.
* Completes the protocol informed consent form.
* Non-smoker, defined by having never smoked or having quit \>6 consecutive months prior to screening.
* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see 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 full or partial craniomaxillofacial 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.
* Consents to cell collection, storage, and bone marrow infusion as part of the treatment regime.
* USA citizen or equivalent.
* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.
Exclusion Criteria:
* Positive for any of the following conditions:
* Untreated sepsis.
* HIV (active or seropositive).
* Active tuberculosis.
* Active Hepatitis B infection.
* Hepatitis C.
* Viral encephalitis.
* Toxoplasmosis.
* Malignancy (within past 5 years).
* Current/recent (within 3 months of donation/screening consent) IV drug abuse.
* Paralysis of ischemic, traumatic, or congenital origin.
* 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.
* 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.
* A history of medical non-compliance.
* Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigen (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.
* Subjects with inadequate donor sites for autologous reconstruction in the event of post-transplant flap failure.
* Patients considered unsuitable per the consulted Psychiatric/ Psychologic appraisal.
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