Ear, Nose and Throat (Otolaryngology) – Head and Neck Surgery

The Tracheal Transplant Program

The Department of Otolaryngology – Head and Neck Surgery and Transplantation created the world’s first Tracheal Transplant and Airway Reconstruction Program. Mount Sinai obtained approval in 2016 for a clinical trial to perform the first long segment tracheal transplant using a trachea from a deceased donor.

On January 13, 2021, what was believed to be impossible for more than half a century became possible. Led by Dr. Eric M. Genden, Chair of the Department of Otolaryngology – Head and Neck Surgery at the Mount Sinai Health System and Dr. Sander Florman, Director of the Recanati/Miller Transplantation Institute, a team of more than 50 experts transplanted the first long segment donor tracheal transplant.

The goal of this Program is to offer patients who have sustained extensive damage to the trachea a lasting alternative to current treatments, including tracheostomy. Existing treatments are only effective in approximately half of the surgeries performed, may only be temporary and are often associated with complications, such as scarring or airway obstruction. The donor tracheal transplantation offers new hope to candidates, particularly those who have suffered:

  • Trauma/accidents to the trachea
  • Intubation damage
  • Airway tumors
  • Congenital tracheal defects

About the Trachea

The trachea is a complex tube that allows air to travel from your mouth to your lungs as you take a deep breath. When the trachea is damaged, individuals may experience difficulty breathing or an inability to speak. Some of those who have sustained defects to the trachea may require a tracheotomy (a hole in the neck) in order to restore normal breathing. This can leave patients socially isolated and depressed.

Prior to 2021, no effective solution to reconstruct and revascularize the trachea existed. A significant factor in previous attempts was the belief that the trachea was simply a tube that could be replaced with synthetic materials or stem cells. Surgeons at Mount Sinai, who have been researching tracheal function for more than 20 years, recognized that the trachea was not merely a tube, as the cilia, which are short hair-like or shag carpet-like structures lining the trachea, performed a critical function of clearing pollutants from the human airway. They also discovered that the replacement trachea needed to withstand the pressures of breathing/respiration.

Groundbreaking Donor Tracheal Transplant Procedure at Mount Sinai

Led by Dr. Eric M. Genden, Chair of the Department of Otolaryngology – Head and Neck Surgery at the Mount Sinai Health System and Dr. Sander Florman, Director of the Recanati/Miller Transplantation Institute, the Tracheal Airway and Transplant Program employs a new protocol using donor trachea to reconstruct the recipient’s damaged airway. This protocol does not involve “tissue-engineered” or “bioengineered synthetic” trachea; rather donor trachea only.

The transplant protocol at Mount Sinai utilizes a segment of trachea with the thyroid gland and its associated vessels. Research suggests that this approach may provide patients with a unique opportunity to breathe and speak normally. Additionally, procurement of the donor tissue allows our surgeons to research the graft and improve our reliability for patients and their families.

About Tracheal Transplant Lead Investigator Dr. Eric Genden

Lead investigator for this tracheal transplant clinical trial is Dr. Eric M. Genden, who is recognized worldwide for his work on airway reconstruction and tracheal transplantation. He began his immunobiology of tracheal transplantation studies in 1992, and published nationally and internationally on the findings that derived from his laboratory at the Icahn School of Medicine at Mount Sinai, funded by the National Institutes of Health. Additionally, Dr. Genden received numerous awards for his extraordinary discoveries in the basic research laboratory, as well as his work in the clinical arena.

In 2003, Dr. Genden performed the first reported tracheal transplant that combined donor trachea cartilage with tissue from his patient. This innovative technique minimized the potential for rejection and allowed the patient to communicate normally after surgery. Investigators in his laboratory have been studying tracheal transplantation in animal models for more than 20 years. Laboratory research, various donor procurement practice sessions and now this first ever tracheal transplantation conducted by Dr. Genden and his investigators has demonstrated that direct donor tracheal transplant may be safe and effective in humans.

Who is Eligible for Tracheal Transplant Consideration?

The ongoing tracheal transplant trial is designed to provide hope for the patients with long segment tracheal defects. Many of these patients are unable to speak or breathe without the help of a tracheostomy. Defects that are greater than 4 to 5 cm in length are not often manageable with surgical reconstruction. As a result, tracheal transplantation represents a viable solution. The following are criteria for potential trachea transplant candidates:

  • Male or female between the ages of 18 and 75 years old
  • Circumferential tracheal defect > 4cm including suprasternal, cervical and upper thoracic locations, due to prolonged intubation, idiopathic scar, autoimmune disorder or trauma
  • Able to provide written informed consent
  • Willing and able to complete all pre-transplant examination and evaluation procedures
  • Approved by a Transplant Recipient Review Committee for placement on the UNOS waiting list
  • Compatible blood type and cross-match with donor

For more information, please email ENTheadneck@mountsinai.org.