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

Tracheal Airway and Transplant Program

The trachea is the 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 damage 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. Currently, there is no effective way to reconstruct the trachea. However, pioneering researchers and surgeons at the Head and Neck Institute at the Mount Sinai Health System have introduced the Tracheal Airway and Transplant Program, designed to perform tracheal transplantation for patients in need.

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.

Purpose of the Tracheal Transplant Trial

Patients who sustain extensive (severe) damage to the trachea (tube in the throat that moves air to and from the lungs) are often left with airways that are not compatible with life or require surgical resection that may leave them unable to communicate with a normal voice and severe scarring due to an external airway created in the neck area.

The current treatments for extensive tracheal damage 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 (complete blockage of the airway preventing the ability to breathe). In those patients with the most severe damage, there are no viable (possible) treatment options available.

The purpose of this study is to determine the safety and efficacy of donor tracheal transplantation for extensive tracheal damage.

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 conducted by Dr. Genden and his investigators has demonstrated that direct donor tracheal transplant may be safe and effective in humans. This trial at Mount Sinai marks the first study of tracheal transplantation in human subjects.

Who is Eligible for Participation in the Tracheal Transplant Trial?

The 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 the team is seeking from potential 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 contact Tanya Sharrieff at 212-241-1963 or Tanya.Sharrieff@mountsinai.org.