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

NCT ID: NCT02165865

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-12-31

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 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.

Conditions

Traumatic Amputation of Arm; Traumatic Amputation of Hand

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

upper extremity/ hand transplantation

hand transplant on unilateral dominant hand or bilateral upper extremity amputees

Group Type: EXPERIMENTAL

upper extremity/ hand transplantation

Intervention Type: PROCEDURE

hand transplant on unilateral dominant hand or bilateral upper extremity amputees

Interventions

upper extremity/ hand transplantation

hand transplant on unilateral dominant hand or bilateral upper extremity amputees

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Medical Center Foundation

OTHER

Sponsor Role: collaborator

Memorial Medical Center

OTHER

Sponsor Role: collaborator

Southern Illinois University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael W Neumeister, MD

Role: PRINCIPAL_INVESTIGATOR

Southern Illinois University

Locations

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

Countries

United States

Related Links

https://www.memorialmedical.com/Medical-Services-Programs/Transplant-Services

Transplant Services at Memorial Medical Center

Other Identifiers

NEU-SIUSOM-13-001

Identifier Type: -

Identifier Source: org_study_id