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

Completed · Not applicable

Conditions studied: Traumatic Amputation of Arm, Traumatic Amputation of Hand

In brief

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.

Key facts

Study ID

NCT02165865

Run by

Southern Illinois University

People needed

2

Starts

2014-01-01

Expected to finish

2017-12-01

Last updated by the study team

2019-07-02

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Memorial Medical Center — Springfield, Illinois, United States
• SIU Institute for Plastic Surgery — Springfield, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States

Full record on ClinicalTrials.gov

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