Vascularized Composite Allotransplantation of the Hand and Upper Extremity (Hand Transplant)
Condition: Traumatic Amputation of Arm; Traumatic Amputation of Hand
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary
      research effort with the goal of restoring form and function to unilateral or bilateral upper
      extremity amputees by vascularized composite allotransplantation of the hand/upper extremity
      (hand transplantation). Hand transplantation includes transferring upper extremities/hands
      from deceased human donors to patients with single or bilateral hand or arm amputation. The
      purpose of the trial is to study functional, psychological, and immunological outcomes of
      human upper extremity allotransplantation.
    

Detailed description: 
      Hand transplantation is the surgical attachment of a hand and sometimes an arm from an organ
      donor to a person who has previously suffered an amputation. It is similar to other organ
      transplants, such as a heart, liver, or kidney, in that the tissue comes from a deceased
      donor and therefore requires lifelong medications to prevent rejection. Hand transplantation
      also requires extensive hand rehabilitation to regain function of the transplanted limb.

      The primary focus of the study is to perform hand transplantation using a steroid-sparing
      immunosuppression regimen, to closely follow outcomes for at least 2 years after the
      transplant, and to utilize new methods for immune system and functional recovery. The number
      and severity of side effects and the treatment provided will be analyzed in relation to the
      standard immunosuppressive drugs used. Functional and clinical outcomes will be correlated
      with data on quality of life.

      After consultation with the study team and signing of the study consent forms, patients will
      undergo a thorough screening phase, including imaging, laboratory tests, age-appropriate
      screening, psychosocial evaluations, physical and occupational therapy (OT) screening, and
      tissue typing. Patients will then be selected by a formal patient selection committee
      meeting, based on results of screening procedures.

      If found to be a good candidate for hand transplantation, the patient will be listed with the
      United Network for Organ Sharing (UNOS) to wait for a compatible donor. Organ donors from the
      surrounding region will be screened for compatibility in regards to blood type and tissue
      type, as well as hand size, skin color, tone, and hair patterns. Once a matching donor is
      located, the hand transplant team and participant will be notified.

      After surgery the patient will stay in the intensive care unit for 1-3 days and then move to
      a regular hospital room where they will stay for 1-2 weeks. Physical therapy will begin
      within 2-3 days after surgery, and transplant staff will give daily information on the
      anti-rejection medications. After discharge from the hospital, the patient will stay locally
      for 3-6 months to monitor for signs of rejection and for extensive hand rehabilitation.
      Housing will be provided during this period by the hospital. Functional, psychological and
      immunological outcomes will then be closely followed for the life of the allograft.
    

Intervention name(s): upper extremity/ hand transplantation
Intervention type(s): Procedure
Intervention description(s): hand transplant on unilateral dominant hand or bilateral upper extremity amputees
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hand transplantation; hand allotransplantation; upper extremity transplantation; upper extremity amputation; hand amputation; vascularized composite allotransplantation; composite tissue allotransplantation; variance component analysis (VCA); composite tissue allograft (CTA)