Ensayos clínicos

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<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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/26/23. Questions regarding updates should be directed to the study team contact.