Human Craniomaxillofacial Allotransplantation

Exclusion Criteria

• •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.
• •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.