NCT03269396

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
85mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
May 2023May 2033

First Submitted

Initial submission to the registry

August 7, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
5.7 years until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2033

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

August 7, 2017

Last Update Submit

August 30, 2025

Conditions

Larynx StenosisLarynx DiseaseLaryngectomyLarynxLarynx Fracture

Keywords

severe laryngotracheal dysfunction

Outcome Measures

Primary Outcomes (1)

  • Survival of the allograft at the one-year visit.

    Survival of the allograft as indicated by histological rejection grading.

    1 year

Secondary Outcomes (4)

  • Swallowing without aspiration at the one-year visit.

    1 year

  • Voice Evaluation

    1 year

  • Pulmonary function

    1 year

  • Ability to have tracheotomy tube decannulated

    1 year

Study Arms (1)

Larynx Allograft Transplantation

EXPERIMENTAL

Cadaveric laryngotracheal transplantation

Procedure: Larynx Allograft Transplantation

Interventions

Larynx Allograft TransplantationPROCEDURE

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.

Larynx Allograft Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 years and older
  • Male or Female
  • One of the following:
  • Severe laryngeal dysfunction as described above
  • Laryngeal stenosis
  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

MeSH Terms

Conditions

LaryngostenosisLaryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic DiseasesRespiratory System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • David G Lott, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant-Department of Otolaryngology Head & Neck Surgery/Audiology

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 31, 2017

Study Start

May 19, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2033

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)