Laryngeal Allograft Transplantation

A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation

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.

Study Overview

• Status: Suspended
• Conditions: Larynx; Larynx Disease; Laryngectomy; Larynx Stenosis; Larynx Fracture
• Intervention / Treatment: Procedure: Larynx Allograft Transplantation

Detailed Description

Patients with severe laryngeal or laryngotracheal incompetence without other reconstructive options will be considered for cadaveric laryngotracheal transplantation. Data will be collected from 10 patients and will include length of hospital stay, short-term complications, long-term complications, hospital readmission, return trips to the operating room (OR), rejection episodes and severity, swallowing function, ability to have tracheotomy tube decannulated, voice parameters, pulmonary function, development of anti-donor antibodies, and quality of life scores.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Larynx Allograft Transplantation; Cadaveric laryngotracheal transplantation	Procedure: Larynx Allograft Transplantation; This study is a prospective clinical trial designed to assess the efficacy and safety of laryngeal transplantation. A total of 10 patients will be enrolled over a five-year timeframe. Study length is 5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the allograft at the one-year visit.	Survival of the allograft as indicated by histological rejection grading.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing without aspiration at the one-year visit.		1 year
Voice Evaluation	Standard voice evaluation will include voice recordings, acoustic and aerodynamic measurements as compared to baseline measurements.	1 year
Pulmonary function	Pulmonary function values within normal range.	1 year
Ability to have tracheotomy tube decannulated	Ability to have tracheotomy tube decannulated after successful capping trials.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David G Lott, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Larynx and trachea transplant

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2033

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: severe laryngotracheal dysfunction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Congenital Abnormalities; Otorhinolaryngologic Diseases; Respiratory System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Laryngeal Diseases; Laryngostenosis
• Other Study ID Numbers: 15-005642; NCI-2024-05947 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No