Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Unspecified Injury Of Upper Extremity
    Unspecified Injury Of Head
  • Age: Between 18 Year(s) - 64 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are 18 years of age or older
    2. Subjects who are able and willing to provide written informed consent
    3. Subjects with facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon.
    4. Subjects with missing part of one or both hands and forearms.
    5. Subjects must be HIV negative at the time of transplant.
    6. Subjects crossmatch is negative at the time of transplant
    7. Subjects has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.
    8. Subjects has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in upper extremity reconstruction.
    9. Subjects who have the willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery.
    10. Subjects are able to complete pre-transplant examination and screening procedures.
    11. Subjects has been approved by Patient Selection Committee for placement on the recipient waiting list.
    12. Subjects willing to continue immunosuppression regimen as directed by treating physician.
    13. Subjects willing and able to return to follow-up visits as described in treatment plan.
    14. Subjects must have autogenous tissue options available for reconstruction in event of graft failure.
    15. Normal GFR (glomerular filtration rate) >60.
    16. Negative pregnancy test within 48hrs of transplant for women of childbearing age and who agree to use a reliable form of contraception for one year following transplant.

You may not be eligible for this study if the following are true:

    1. Subjects who have uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
    2. Subjects who have serious co-morbidities
    3. Subjects who have positive serology for HIV; Hepatitis B Antigen
    4. Subjects who have active malignancy within 5 years with the exclusion of non-melanoma
    5. Subjects who have substance abuse disorders not currently under control
    6. Subjects with Body Dysmorphic disorder
    7. Subjects with Active Severe Psychiatric Illness
    8. Subjects currently active smoker within 1 year
    9. Subjects with any cognitive deficits related to a TBI (traumatic brain injury) and or any organic neurological disorders
    10. Subjects with any other psychological status that would hinder the success or safety of the transplantation.
    11. Subjects who have level of amputation proximal to mid-humerus: some presence of proximal muscles is required to motor a functioning hand.
    12. Subjects who have Congenital Abnormalities: co-existent absence/atrophy/agenesis of any tissue that may affect post-transplant results
    13. Subjects who have history of amputation of less than six months: subject must be allowed to attempt prosthetic use prior to hand transplantation.
    14. Subjects with blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation
    15. Subjects who are pregnant

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