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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.

objective, standardized tests of graft rejection