Composite tissue allotransplantation (CTA) has emerged as a promising surgical option to restore the form and function of missing or severely damaged structures such as the face, hands, or trachea. Currently, there are four active CTA programs in the United States and numerous others under development. The process of development of a CTA program in the United States involves successful collaboration between a strong project leader with vested clinical research interest, a multidisciplinary team of investigators, an Institutional Review Board, a regional Organ Processing Organization (PO), and the hospital's administration. The process of establishment of a CTA program can be slow and lengthy, therefore the project leader must strive to maintain the enthusiasm alive and drive the project forward. At all phases of development, the project must remain focused on the patients, must recognize and address all potential patient safety issues, must take into account the concerns, issues and logistic hurdles faced by the OPO, and must be financially responsible by ensuring that postoperative costs related to medical care and life-long immunosuppression are covered by medical insurance. This article describes the process of establishment of a CTA program at Brigham and Women's Hospital, Boston, MA with special emphasis on strategy and planning.
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