Laryngeal Allograft Transplantation

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\<18)(Exceptional cases will be considered on a case by case basis) Significant renal dysfunction (Creatinine clearance \< 50 ml/min.)
  • Significant hepatic dysfunction
  • Significant kidney damage
  • Unmanageable infections
  • Unable to participate in preoperative exercise training
  • Unable to be weaned to equal or less than 10 mg/day of steroids
  • Untreatable cardiac disease
  • Active neuromuscular disease
  • History of recurrent aspiration or active, unmanageable Gastro-Esophageal Reflux
  • Patients with active connective tissue diseases (exceptions to be considered in a case by case basis)
  • Patients unable to achieve > 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