Laryngeal TransplantationECLATNCT02821299
Clinical Evaluation of Laryngeal Transplantation: Study of 3 Patients
A study testing Laryngeal transplantation in people with Laryngeal Transplantation, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
The experience of face and hand composite tissue transplantations reported in the international community have mainly concerned trauma patients. Feasibility and individual benefit have been demonstrated for these indications, in properly selected patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laryngeal Transplantation
- What is being tested?
- Laryngeal transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Sep 2018to 20 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting with the permanent loss of laryngeal functions. Loss of laryngeal function is considered when a patient is permanently tracheotomized, is mutic and presented failure for each of the three conventional treatment. Conventional treatment lines are organized in the following manner firstly laser, then prosthesis and lastly surgery) Diet may be normal.
- Adults aged between 18 to 60 years;
- ASA (American Society of Anesthesiology) score < 3 and the health status of the patients must be compatible not only with the graft but also with all the treatments envisaged by the study (according investigator assessment);
- Psychological maturity: recipients should be psychologically balanced, assessed by the team psychiatrists, have taken personality tests, determined and willing, capable of understanding the information provided on the risks relating to the surgery and the immunosuppressive treatment, and capable of making their own decision regarding the transplantation. The psychological preparation for the transplantation requires relationships to be built up prior to the procedure between the patient, the team providing care for laryngectomized patients, the rehabilitation team, the surgical team and the psychiatrist;
- Patients capable of understanding the information provided on the risks relating to the study, and capable of making their own decision regarding the transplantation according investigator assessment;
- Having given written informed consent prior to any procedure related to the study;
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
Who cannot join
- Minors or patients aged over 60 years;
- Patients with a history of cancer of the upper airways or upper digestive tract; excepted:
- Patients, non-smoker, who have undergone total laryngectomy for squamous cell carcinoma of the larynx, in complete remission for at least 5 years *. Remission for at least 5 years will be confirmed with imaging, endoscopy or histology.
- Patients with low-grade chondrosarcoma of the larynx, a tumor with very low metastatic potential, often classified as intermediate or even benign (complete resection with histologically confirmed healthy margins)*
- Patients who are already receiving immunosuppressive treatment (Only patients already receiving an immunosuppressive dose equivalent to that specified in the study protocol may be considered under this criterion)
- Patients with a history of other types of malignancy;
Show all 20Show fewer
- Patients presenting with a progressive malignant tumor; suspicious laryngeal lesions (dysplasia ...)
- Patients with addiction to alcohol and/or smoking (Consumption of alcohol in the last 5 years and/or consumption of more than 10 packs per year that has not been stopped in the last 5 years).
- Patient presenting hepatitis B, hepatitis C, or HIV(Human Immunodeficiency Virus) infection;
- Patients with a history of psychiatric disorders: known delusional psychosis, untreated severely depressed patients, patients with severe behavioral disorders, patients with permanent generalized anxiety disorder,
- ASA (American Society of Anesthesiology) score ≥ 3;
- Patients presenting moderate renal failure which does not justify renal transplantation with a glomerular filtration rate of less than 60 mL/min per 1.73 m2 calculated using the CKD-EPI formula;
- Arterial hypertension treated by more than one therapy;
- Testing for anti-HLA antibodies will be carried out at the initial inclusion visit, a cross-match will be carried out immediately before transplantation, a positive cross-match will be considered as an automatic contraindication to carrying out the transplantation;
- Women who are pregnant or not taking contraception (effective contraceptive method compulsory);
- Women who are breastfeeding;
- People who have been deprived of their freedom through a legal or administrative decision;
- Adult with a legal guardian;
- Patients in emergency situations;
- EBV (Epstein-Barr Virus) seronegative recipient with EBV seropositive graft, due to the risk of lymphoma.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69003
Lionel BADET, MD
Lionel BADET, MD
- Recruiting
Service ORL & Chirurgie Cervicofaciale - Hôpital Charles Nicolle - CHU Rouen
Rouen, 76000
Jean-Paul MARIE, MD
Jean-Paul MARIE, MD
- Recruiting
Centre de soins de suite et de réadaptation fonctionnelle - SSR Val Rosay
Saint-Didier-au-Mont-d'Or, 69370
Cherryfat GIWA, MD
Cherryfat GIWA, MD
About this study
Official title: Clinical Evaluation of Laryngeal Transplantation: Pilot Study of 3 Patients
The experience of face and hand composite tissue transplantations reported in the international community have mainly concerned trauma patients. Feasibility and individual benefit have been demonstrated for these indications, in properly selected patients. The first laryngeal transplantation also concerned a case of post-traumatic reconstruction. A certain number of patients, who have suffered direct (extended period of intubation during a stay in the ICU, road traffic accident etc.) or indirect trauma (thermal or chemical burns) to the larynx, present irreversible trauma or injury to the larynx in which conventional treatments are unable to restore laryngeal function. These patients find themselves severely disabled, with a significant reduction in their quality of life. They suffer from stigmatization which leads to social isolation (professional and personal). In some circumstances, providing healthy tissue and anatomical or functional components (cartilage, muscle, nerves, blood vessels) by means of an allogeneic laryngeal transplantation, is the only way of allowing patients, whose quality of life has been seriously affected, to speak, breath and swallow normally. The extremely promising results from other international teams in this area have encouraged the investigators to present this project.
The specificities of the protocol compared to previous transplantations carried out by other teams are:
Read more
- The technique for nerve re-innervation which should make it possible to decannulate all patients and improve functional outcomes in the graft.
- A dual therapy immunosuppressive regimen will be used, if the patient's clinical and biological status permits, which can be adjusted according to the type of tissue grafted.
It might be thought that the need for immunosuppressive therapy means the indications will remain rare, representing an incidence of less than five patients a year in France. However, the interest of this research project does not reside in the number of patients concerned but rather the total lack of any existing therapeutic solution. Conducting a case series will help determine whether, under certain conditions, laryngeal transplantation can improve the management of patients for whom the usual reconstructive surgery options are unsatisfactory.
The study is intended to provide a descriptive analysis of a case series of three laryngeal transplantations before and after comparisons, each patient serving as their own control.
- Conditions
- Laryngeal Transplantation
- Being tested
- Laryngeal transplantation
- Keywords
- Laryngeal transplantation, Laryngeal function, Swallowing, Voice production, Respiration, Quality of life
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal transplantationOther
Laryngeal transplantation
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal transplantation | Experimental | Laryngeal transplantation Receives: Other: Laryngeal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing evaluation measured using the "Deglutition Handicap Index"
The laryngeal transplantation will be evaluated with a primary composite endpoint based on the three inseparable laryngeal functions: swallowing evaluation will be mainly measured using the "Deglutition Handicap Index"
Measured: 3 years post transplantation
Voice production evaluated by self-report VHI (Voice Handicap Index) patient questionnaires
The laryngeal transplantation will be evaluated with a primary composite endpoint based on the three inseparable laryngeal functions: Voice production will be evaluated by self-report VHI (Voice Handicap Index) patient questionnaires
Measured: 3 years post transplantation
Respiration evaluated by decannulation
The laryngeal transplantation will be evaluated with a primary composite endpoint based on the three inseparable laryngeal functions: Respiration, for which the decannulation remains the most appropriate criterion.
Measured: 3 years post transplantation
Graft survival
Measured: 3 years post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start20 Sep 2018
- Primary completion20 Sep 2030 (estimated)
- Study completion20 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821299
- Sponsor's protocol ID
- 69HCL14_0443
- Other IDs
- 2016-A00767-44
- Acronym
- ECLAT
- Status last verified
- Feb 2026
- First submitted
- 9 Jun 2016
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Laryngeal Transplantation: Pilot Study of 3 Patients
- ClinicalTrials.gov ID
- NCT02821299
- Acronym / sponsor ID
- ECLAT / 69HCL14_0443
- Conditions
- Laryngeal Transplantation
- Keywords
- Laryngeal transplantation, Laryngeal function, Swallowing, Voice production, Respiration, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 20 Sep 2030 (estimated)
- Study completion
- 20 Sep 2030 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- 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 experience of face and hand composite tissue transplantations reported in the international community have mainly concerned trauma patients. Feasibility and individual benefit have been demonstrated for these indications, in properly selected patients. The first laryngeal transplantation also concerned a case of post-traumatic reconstruction. A certain number of patients, who have suffered direct (extended period of intubation during a stay in the ICU, road traffic accident etc.) or indirect trauma (thermal or chemical burns) to the larynx, present irreversible trauma or injury to the larynx in which conventional treatments are unable to restore laryngeal function. These patients find themselves severely disabled, with a significant reduction in their quality of life. They suffer from stigmatization which leads to social isolation (professional and personal). In some circumstances, providing healthy tissue and anatomical or functional components (cartilage, muscle, nerves, blood vessels) by means of an allogeneic laryngeal transplantation, is the only way of allowing patients, whose quality of life has been seriously affected, to speak, breath and swallow normally. The extremely promising results from other international teams in this area have encouraged the investigators to present this project.
The specificities of the protocol compared to previous transplantations carried out by other teams are:
- The technique for nerve re-innervation which should make it possible to decannulate all patients and improve functional outcomes in the graft.
- A dual therapy immunosuppressive regimen will be used, if the patient's clinical and biological status permits, which can be adjusted according to the type of tissue grafted.
It might be thought that the need for immunosuppressive therapy means the indications will remain rare, representing an incidence of less than five patients a year in France. However, the interest of this research project does not reside in the number of patients concerned but rather the total lack of any existing therapeutic solution. Conducting a case series will help determine whether, under certain conditions, laryngeal transplantation can improve the management of patients for whom the usual reconstructive surgery options are unsatisfactory.
The study is intended to provide a descriptive analysis of a case series of three laryngeal transplantations before and after comparisons, each patient serving as their own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngeal transplantation | Experimental | Other: Laryngeal transplantationLaryngeal transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients presenting with the permanent loss of laryngeal functions. Loss of laryngeal function is considered when a patient is permanently tracheotomized, is mutic and presented failure for each of the three conventional treatment. Conventional treatment lines are organized in the following manner firstly laser, then prosthesis and lastly surgery) Diet may be normal.
- Adults aged between 18 to 60 years;
- ASA (American Society of Anesthesiology) score < 3 and the health status of the patients must be compatible not only with the graft but also with all the treatments envisaged by the study (according investigator assessment);
- Psychological maturity: recipients should be psychologically balanced, assessed by the team psychiatrists, have taken personality tests, determined and willing, capable of understanding the information provided on the risks relating to the surgery and the immunosuppressive treatment, and capable of making their own decision regarding the transplantation. The psychological preparation for the transplantation requires relationships to be built up prior to the procedure between the patient, the team providing care for laryngectomized patients, the rehabilitation team, the surgical team and the psychiatrist;
- Patients capable of understanding the information provided on the risks relating to the study, and capable of making their own decision regarding the transplantation according investigator assessment;
Key exclusion criteria (20 listed)
- Minors or patients aged over 60 years;
- Patients with a history of cancer of the upper airways or upper digestive tract; excepted:
- Patients with a history of other types of malignancy;
- Patients presenting with a progressive malignant tumor; suspicious laryngeal lesions (dysplasia ...)
- Patients with addiction to alcohol and/or smoking (Consumption of alcohol in the last 5 years and/or consumption of more than 10 packs per year that has not been stopped in the last 5 years).
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 |
|---|---|---|
| Laryngeal transplantationLaryngeal transplantation | Other | Laryngeal transplantation |
Primary outcome
Swallowing evaluation measured using the "Deglutition Handicap Index"
Time frame: 3 years post transplantation
The laryngeal transplantation will be evaluated with a primary composite endpoint based on the three inseparable laryngeal functions: swallowing evaluation will be mainly measured using the "Deglutition Handicap Index"
Voice production evaluated by self-report VHI (Voice Handicap Index) patient questionnaires
Time frame: 3 years post transplantation
The laryngeal transplantation will be evaluated with a primary composite endpoint based on the three inseparable laryngeal functions: Voice production will be evaluated by self-report VHI (Voice Handicap Index) patient questionnaires
Respiration evaluated by decannulation
Time frame: 3 years post transplantation
The laryngeal transplantation will be evaluated with a primary composite endpoint based on the three inseparable laryngeal functions: Respiration, for which the decannulation remains the most appropriate criterion.
Graft survival
Time frame: 3 years post transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal transplantation in people with Laryngeal Transplantation, run by Hospices Civils de Lyon at 3 sites in France.
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 7 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lionel BADET, MD (4 72 11 11 42 ext. +33, lionel.badet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing evaluation measured using the "Deglutition Handicap Index" (time frame: 3 years post transplantation). The study lists 4 primary outcomes in all. 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 17 Feb 2026.