Laryngeal Allograft Transplantation

Larynx Clinical Trial

Official title:

A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03269396
• Other study ID #: 15-005642
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 2028

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Diseases
• Laryngectomy
• Larynx
• Larynx Disease
• Larynx Fracture
• Larynx Stenosis

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of the allograft at the one-year visit.	Survival of the allograft as indicated by histological rejection grading.	1 year
Secondary	Swallowing without aspiration at the one-year visit.		1 year
Secondary	Voice Evaluation	Standard voice evaluation will include voice recordings, acoustic and aerodynamic measurements as compared to baseline measurements.	1 year
Secondary	Pulmonary function	Pulmonary function values within normal range.	1 year
Secondary	Ability to have tracheotomy tube decannulated	Ability to have tracheotomy tube decannulated after successful capping trials.	1 year

External Links

•   Mayo Clinic Clinical Trials