Larynx StenosisNCT03269396
Laryngeal Allograft Transplantation
A study testing Larynx Allograft Transplantation in people with Larynx Stenosis and Larynx Disease, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Stenosis, Larynx Disease, Laryngectomy
- What is being tested?
- Larynx Allograft Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to May 2033
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Larynx Stenosis, Larynx Disease, Laryngectomy, Larynx, Larynx Fracture
- Being tested
- Larynx Allograft Transplantation
- Keywords
- severe laryngotracheal dysfunction
- Medical subject headings
- Laryngostenosis, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Larynx Allograft TransplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Larynx Allograft Transplantation | Experimental | Cadaveric laryngotracheal transplantation Receives: Procedure: Larynx Allograft Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the allograft at the one-year visit.
Survival of the allograft as indicated by histological rejection grading.
Measured: 1 year
Secondary outcomes (4)
Swallowing without aspiration at the one-year visit.
Measured: 1 year
Voice Evaluation
Standard voice evaluation will include voice recordings, acoustic and aerodynamic measurements as compared to baseline measurements.
Measured: 1 year
Pulmonary function
Pulmonary function values within normal range.
Measured: 1 year
Ability to have tracheotomy tube decannulated
Ability to have tracheotomy tube decannulated after successful capping trials.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start19 May 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2033 (estimated)
Why it stopped: Protocol revision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx StenosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David G. Lott, M.D., Mayo Clinic
- Investigators
- David G Lott, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269396
- Sponsor's protocol ID
- 15-005642
- Other IDs
- NCI-2024-05947
- Status last verified
- Jul 2026
- First submitted
- 7 Aug 2017
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation
- ClinicalTrials.gov ID
- NCT03269396
- Acronym / sponsor ID
- 15-005642
- Conditions
- Larynx Stenosis, Larynx Disease, Laryngectomy, Larynx, Larynx Fracture
- Keywords
- severe laryngotracheal dysfunction
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol revision
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Larynx Allograft Transplantation | Experimental | Procedure: Larynx Allograft TransplantationCadaveric laryngotracheal transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18 years and older
- Male or Female
- One of the following:
- Ability to obtain informed consent from the patient
Key exclusion criteria (28 listed)
- 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
- Psychosocial parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Larynx Allograft TransplantationThis 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. | Procedure or surgery | Larynx Allograft Transplantation |
Primary outcome
Survival of the allograft at the one-year visit.
Time frame: 1 year
Survival of the allograft as indicated by histological rejection grading.
4 secondary outcomes
Swallowing without aspiration at the one-year visit.
Time frame: 1 year
Voice Evaluation
Time frame: 1 year
Pulmonary function
Time frame: 1 year
Ability to have tracheotomy tube decannulated
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Lott, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Larynx Allograft Transplantation in people with Larynx Stenosis and Larynx Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the allograft at the one-year visit. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.