Laryngeal Allograft Transplantation

The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.

Potential subjects for this study include patients with severe laryngeal dysfunction or a previous laryngectomy. For the purposes of this study, severe laryngeal dysfunction is defined as the loss of normal laryngeal function resulting in significant dysphonia, dysphagia, or dyspnea. Inclusion Criteria: * Ages 18 years and older * Male or Female * One of the following: * Severe laryngeal dysfunction as described above * Laryngeal stenosis * 5 years or longer s/p definitive management for head and neck cancer * Laryngeal cancer requiring total laryngectomy in a patient already on immunosuppression * Low-grade chondrosarcoma requiring total laryngectomy * Ability to obtain informed consent from the patient Exclusion Criteria: Poor surgical candidacy secondary to poor physical/mental health as determined by a pre-operative medical evaluation General medical status * Pregnancy * Any systemic disease which would alter life expectancy * Active neoplastic disease, not considered yet to be cured (Exceptional cases will be considered in case by case discussion)Less than 5 years s/p definitive management for cancer * Cancer within the last 5 years (Exceptional cases will be considered in case by case discussion) * Obesity (Body Mass Index \>29 - 30)(Exceptional cases will be considered on a case by case basis) * Cachexia (BMI\ 600 feet in a 6 minute walk test (exceptions to be considered in a case by case basis) * Patients considered having active immunodeficiency disorders (exceptions to be considered in a case by case basis) * Multiple co-morbidities that would make transplantation prohibitively risky * Psychosocial parameters * Severe mental retardation, psychosis, depression or organic brain syndrome * Uncontrolled diabetes mellitus. Once HbA1C \< 7, reevaluate for candidacy. * Active substance use within 6 months * Active smoking within 6 months * Active alcoholism within 6 months * Inability to comply with transplant-related management and medical follow-up * Any other circumstances that deem the candidate high risk from a psychosocial perspective