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

Traumatic Amputation of Arm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165865
• Other study ID #: NEU-SIUSOM-13-001
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Traumatic Amputation of Arm
• Traumatic Amputation of Hand

Intervention

Procedure:
• upper extremity/ hand transplantation
hand transplant on unilateral dominant hand or bilateral upper extremity amputees

Locations

Country	Name	City	State
United States	Memorial Medical Center	Springfield	Illinois
United States	SIU Institute for Plastic Surgery	Springfield	Illinois
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Southern Illinois University	Memorial Medical Center, Memorial Medical Center Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hand allograft survival		Transplantation through end of study period (up to 5 years)
Secondary	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)
Secondary	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)
Secondary	brain cortical reorganization and adaptation	functional MRI	Transplantation through end of study period (up to 5 years)
Secondary	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)

External Links

•   Hand Transplant Surgery at the Institute for Plastic Surgery at SIU School of Medicine
•   Transplant Services at Memorial Medical Center