Laryngeal Allograft Transplantation

Not Applicable

• Conditions: Larynx Fracture; Larynx Disease; Laryngectomy; Larynx Stenosis; Larynx
• Interventions: Procedure: Larynx Allograft Transplantation

• Registration Number: NCT03269396
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Study Start: 2023-05-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2028-05
• Study Completion: 2033-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Larynx Allograft Transplantation	Larynx Allograft Transplantation	Cadaveric laryngotracheal transplantation

Primary Outcome Measures

Name	Time	Method
Survival of the allograft at the one-year visit.	1 year	Survival of the allograft as indicated by histological rejection grading.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States