When someone experiences the loss of a limb or severe facial disfigurement, one of their options may be vascularized composite allotransplantation (VCA), which transfers a graft containing multiple tissues transferred as a functional unit. Using VCA to restore the functionality and aesthetics of a lost upper limb or disfigured face is a profound and life-altering gift; however, the process and the decision to accept (or donate) a VCA graft is complex and deeply emotional. In addition to psychosocial considerations, a VCA recipient must commit to undergoing years of rigorous rehabilitation, have a robust support system in place, and accept and understand the risks of being on immunosuppressive drugs for the rest of their life. Despite VCA advances over the last 25 years, challenges remain, and the small number of recipients of face or hand transplants makes it difficult to generalize outcomes.

To address these challenges, the Department of Defense Reconstructive Transplant Research Program tasked a committee of the National Academies with developing principles and a framework for the standardization, assessment, and validation of protocols and standard operating procedures for face and hand transplantation. The resulting report offers guidance for the newly established Clinical Organization Network for Standardization of Reconstructive Transplantation (CONSORT), but it also includes specific recommendations to enable the larger VCA community to mature, advance, and thrive into the future.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• COMMITTEE ON PRINCIPLES AND FRAMEWORK TO GUIDE THE DEVELOPMENT OF PROTOCOLS AND STANDARD OPERATING PROCEDURES FOR FACE AND HAND TRANSPLANTS
• Reviewers
• Acknowledgments
• Preface
• Acronyms and Abbreviations
• Summary
  • STUDY SCOPE AND CONTEXT
  • BACKGROUND ON VCA
  • THE TRANSPLANT EXPERIENCE
  • A FRAMEWORK FOR STANDARDIZING FACE AND HAND TRANSPLANTATION
  • OVERARCHING CONCLUSIONS AND RECOMMENDATIONS
• I. Background on VCA
  • 1. Introduction and Study Context
    • STUDY ORIGIN AND STATEMENT OF TASK
    • STUDY CONTEXT
    • STUDY SCOPE AND FOCUS
    • METHODOLOGY AND STUDY APPROACH
    • REPORT ORGANIZATION AND GOALS
    • REFERENCES
  • 2. VCA Background Information and Context
    • VCA: DEFINITION AND BACKGROUND
    • U.S. FACE AND HAND TRANSPLANT CENTERS
    • SELECT POPULATIONS AND VCA
    • THE ORGAN DONATION SYSTEM AND VCA
    • CHAPTER 2 KEY FINDINGS
    • REFERENCES
  • 3. Overarching Considerations Influencing Face and Hand Transplantation
    • REGULATORY AND LEGAL CONSIDERATIONS
    • ETHICAL CONSIDERATIONS
    • HIGH-QUALITY CARE CONSIDERATIONS
    • PSYCHOSOCIAL CONSIDERATIONS
    • FINANCING CONSIDERATIONS
    • Chapter 3 KEY FINDINGS
    • THE WAY FORWARD AND OVERARCHING CONCLUSIONS
    • REFERENCES
• II. The Transplant Experience
  • 4. The Transplant Experience: The Preoperative Stage
    • FOCUS AREA DEFINITIONS
    • MULTIDISCIPLINARY TEAMS
    • THE PRETRANSPLANT EXPERIENCE
    • CHAPTER 4 KEY FINDINGS
    • REFERENCES
  • 5. The Transplant Experience: Surgical Procedures and Care Management
    • SURGICAL PROCEDURES
    • POSTTRANSPLANT CARE MANAGEMENT AND MONITORING
    • IMMUNOSUPPRESSION TO MINIMIZE TRANSPLANT REJECTION
    • MONITORING AND CARE MANAGEMENT OF COMPLICATIONS
    • REHABILITATION
    • PSYCHOSOCIAL CARE MANAGEMENT
    • CHAPTER 5 KEY FINDINGS
    • REFERENCES
  • 6. The Transplant Experience: Outcomes
    • OVERVIEW OF HEALTH OUTCOMES
    • OUTCOMES FOLLOWING FACE AND HAND TRANSPLANTATION
    • LIMITATIONS IN CURRENT OUTCOME MEASUREMENTS
    • FUTURE DIRECTIONS
    • CHAPTER 6 KEY FINDINGS
    • THE WAY FORWARD AND OVERARCHING CONCLUSIONS
    • REFERENCES
• III. The Future of Face and Hand Transplantation
  • 7. Framework for the Future and Designing a Productive and Sustainable Clinical Network
    • THE COMMITTEE’S PRINCIPLES, FRAMEWORK, AND VISION FOR THE FUTURE OF FACE AND HAND TRANSPLANTATION
    • GUIDANCE FOR CONSORT
    • DEVELOPMENT OF STANDARDIZED CLINICAL PROTOCOLS AND STANDARD OPERATING PROCEDURES
    • CHAPTER 7 KEY FINDINGS
    • REFERENCES
  • 8. Data Management and Registry Development
    • CURRENT REGISTRIES THAT COLLECT FACE AND HAND TRANSPLANT DATA
    • BEST PRACTICES IN REGISTRY DEVELOPMENT AND EXEMPLARS
    • INFRASTRUCTURE AND SUSTAINABILITY
    • SPECIFIC CONSIDERATIONS FOR PATIENT-REPORTED OUTCOMES IN REGISTRIES
    • PATIENT DATA SHARING AND PRIVACY CONSIDERATIONS
    • INVOLVEMENT OF INTERNATIONAL SITES
    • CHAPTER 8 KEY FINDINGS
    • PART III OVERARCHING CONCLUSIONS
    • REFERENCES
  • 9. Overarching Conclusions and Recommendations
    • OVERARCHING CONCLUSIONS
    • WHOLE HEALTH APPROACH TO FACE AND HAND TRANSPLANT CARE AT DEMONSTRABLY HIGH-QUALITY TRANSPLANT CENTERS
    • COLLABORATION AND STANDARDIZATION
    • SYSTEMATIC APPROACH TO CONTINUED INVESTIGATION
• Appendix A. Biographical Sketches of Committee Members and Staff
• Appendix B. Open Session Agendas
• Appendix C. Timeline of Previous Face and Hand Transplantations
• Appendix D. Relevant National Academies Studies and Historical and Ongoing VCA Work

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2025. Advancing face and hand transplantation: Principles and framework for developing standardized protocols. Washington, DC: The National Academies Press. https://doi.org/10.17226/28580.

Digital Object Identifier: https://doi.org/10.17226/28580

Library of Congress Control Number: 2025938253

This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Printed in the United States of America.