Laryngeal Allograft Transplantation

Paused · Not applicable

Conditions studied: Larynx Stenosis, Larynx Disease, Laryngectomy, Larynx, Larynx Fracture

In brief

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.

Key facts

Study ID

NCT03269396

Run by

Mayo Clinic

People needed

10

Starts

2023-05-19

Expected to finish

2033-05-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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