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

NCT02165865 | Completed

• 1 other identifier: NEU-SIUSOM-13-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

Traumatic Amputation of Arm; Traumatic Amputation of Hand

Keywords

hand transplantation; hand allotransplantation; upper extremity transplantation; upper extremity amputation; hand amputation; vascularized composite allotransplantation; composite tissue allotransplantation; variance component analysis (VCA); composite tissue allograft (CTA)

Outcome Measures

Primary Outcomes (1)

• hand allograft survival

  Transplantation through end of study period (up to 5 years)

Secondary Outcomes (4)

• hand allograft function

  Transplantation through end of study period (up to 5 years)

• immunological response to hand transplantation

  Transplantation through end of study period (up to 5 years)

• brain cortical reorganization and adaptation

  Transplantation through end of study period (up to 5 years)

• psychosocial impact

  Transplantation through end of study period (up to 5 years)

Study Arms (1)

upper extremity/ hand transplantation

EXPERIMENTAL

hand transplant on unilateral dominant hand or bilateral upper extremity amputees

Procedure: upper extremity/ hand transplantation

Interventions

upper extremity/ hand transplantation PROCEDURE

hand transplant on unilateral dominant hand or bilateral upper extremity amputees

upper extremity/ hand transplantation

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Southern Illinois University: lead
• Memorial Medical Center Foundation: collaborator
• Memorial Medical Center: collaborator

Study Sites (3)

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

SIU Institute for Plastic Surgery

Springfield, Illinois, 62794-9653, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9653, United States

Location

Related Links

• Transplant Services at Memorial Medical Center

MeSH Terms

Interventions

Hand Transplantation

Intervention Hierarchy (Ancestors)

Vascularized Composite Allotransplantation; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Transplantation, Homologous

Study Officials

• Michael W Neumeister, MD

  Southern Illinois University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: June 18, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 2, 2019

Record last verified: 2019-07

Locations

US (3)