Clinical trial NCT03269396: Laryngeal Allograft Transplantation
Official title: A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Larynx Stenosis
Larynx Disease
Laryngectomy
Larynx
Larynx Fracture
Keywords: severe laryngotracheal dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival of the allograft at the one-year visit.
timeFrame: 1 year
Secondary outcomes:
measure: Swallowing without aspiration at the one-year visit.
timeFrame: 1 year
measure: Voice Evaluation
timeFrame: 1 year
measure: Pulmonary function
timeFrame: 1 year
measure: Ability to have tracheotomy tube decannulated
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: David G Lott, MD
role: PRINCIPAL_INVESTIGATOR
References: