Human Craniomaxillofacial Allotransplantation

Launched by JOHNS HOPKINS UNIVERSITY · Jun 26, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a new way to perform face transplants for people with serious facial injuries or deformities. The goal is to make face transplantation safer and more effective by using a special treatment plan that reduces the need for strong medications that can cause serious side effects. The researchers aim to perform 15 full or partial face transplants using this innovative approach, which combines techniques to help the body accept the new face with less medication.

To be eligible for this trial, participants must be between 18 and 65 years old and have experienced a severe facial injury at least six months ago. They also need to be healthy enough to undergo surgery and committed to following the treatment plan. If you join the study, you can expect to receive a new face that not only helps with appearance but also restores function, allowing you to speak and eat more easily. This trial offers a chance to recover both physically and emotionally, helping individuals regain confidence and reconnect with their lives.

Gender

ALL

Eligibility criteria

• 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.