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.
Who can participate
Age range18 Years
SexALL
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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.)
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