Vascularized Composite Allotransplantation of the Hand and Upper Extremity (Hand Transplant)

Vascularized Composite Allotransplantation of the Hand and Upper Extremity for the Restoration of Form and Function in Hand Amputees

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Amputation of Arm; Traumatic Amputation of Hand
• Intervention / Treatment: Procedure: upper extremity/ hand transplantation

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Springfield, Illinois, United States, 62781
      • Memorial Medical Center
    • Springfield, Illinois, United States, 62794-9653
      • SIU Institute for Plastic Surgery
    • Springfield, Illinois, United States, 62794-9653
      • Southern Illinois University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss from trauma or other causes desiring limb transplantation
• Below-shoulder amputation
• Male or female and of any race, color or ethnicity
• Aged 18-69 years
• Willing and able to understand and sign informed consent form
• No co-existing medical condition which, in the opinion of the study team, would place them at high risk for the surgical procedure, immunosuppression protocol, or functional results
• No co-existing psychosocial problems (i.e., alcoholism, drug abuse, lack of social support) or issue identified during psychosocial battery of testing
• Negative for malignancy for past 5 years
• Negative for hepatitis C virus or 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
• Willing and able to sign consents for tissue studies
• Willing to comply with Intermediate System (IS) and hand therapy protocols

Exclusion Criteria:

• Conditions that, in the opinion of the investigators, would place patient at unacceptably high risk for the surgical procedure, immunosuppression protocol, or functional results
• Sensitized recipients with high levels (>70%) 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 that may result in poor wound healing after surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: upper extremity/ hand transplantation; hand transplant on unilateral dominant hand or bilateral upper extremity amputees	Procedure: upper extremity/ hand transplantation; hand transplant on unilateral dominant hand or bilateral upper extremity amputees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hand allograft survival	Transplantation through end of study period (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hand allograft function	tests, 2 point discrimination, electromyography (EMG)/nerve conduction studies, range of motion, and a functional status assessment that includes activities of daily living	Transplantation through end of study period (up to 5 years)
immunological response to hand transplantation	white blood cell counts, immunosuppression serum drug levels, donor specific antigen levels, tissue biopsy Banff grades	Transplantation through end of study period (up to 5 years)
brain cortical reorganization and adaptation	functional MRI	Transplantation through end of study period (up to 5 years)
psychosocial impact	Flannagan QOL (quality of life) survey and the Connor-Davidson Resilience Scale (CD-RISC)	Transplantation through end of study period (up to 5 years)

Collaborators and Investigators

• Sponsor: Southern Illinois University
• Collaborators: Memorial Medical Center; Memorial Medical Center Foundation
• Investigators: Principal Investigator: Michael W Neumeister, MD, Southern Illinois University

Publications and helpful links

Helpful Links

• Transplant Services at Memorial Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: hand amputation; vascularized composite allotransplantation; hand transplantation; hand allotransplantation; upper extremity transplantation; upper extremity amputation; composite tissue allotransplantation; variance component analysis (VCA); composite tissue allograft (CTA)
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: NEU-SIUSOM-13-001