BridgeMD
New treatment option for Laryngeal Transplantation
Official title Clinical Evaluation of Laryngeal Transplantation: Study of 3 Patients
ClinicalTrials.gov ID: NCT02821299
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Patients presenting with the permanent loss of laryngeal functions. Loss of laryngeal function is considered when a patient is permanently...
- 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...
- Psychological maturity: recipients should be psychologically balanced, assessed by the team psychiatrists, have taken personality tests, determined...
- Patients capable of understanding the information provided on the risks relating to the study, and capable of making their own decision regarding the...
You likely can't join if
- 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 \...
- Patients with low-grade chondrosarcoma of the larynx, a tumor with very low metastatic potential, often classified as intermediate or even benign...
- Patients who are already receiving immunosuppressive treatment (Only patients already receiving an immunosuppressive dose equivalent to that...
- Patients with a history of other types of malignancy;
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Rouen, France
- Saint-Didier-au-Mont-d'Or, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Rouen, France; Saint-Didier-au-Mont-d'Or, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.