Today, about 60,000 Americans have had their larynx removed due to disease or trauma. These people are missing out on many of life's little pleasures because the procedure's resultant hole left them without a voice and created an opening directly into their lungs. A simple shower is dangerous as even the slightest amount of water in the lungs can be deadly. Bad weather can be lethal. Things that used to be a mere annoyance — such as a housefly — are now life-threatening.

It's not overstating it to say that danger lurks everywhere after a laryngectomy. And just at the time you need extra support, your ability to communicate is greatly impaired. A simple interaction with a store clerk is frustrating and can deliver looks of horror and pity.

As an ear, nose and throat specialist at Mayo Clinic, David Lott, M.D., has seen laryngectomies impair too many lives.

"I'm tired of seeing patients over and over and knowing there's nothing to do," he says. Some patients become so hopeless in the face of a laryngectomy that they forgo the procedure, opting for certain death over such deeply impaired living.

Dr. Lott wants to restore hope for these people. And with the latest breakthroughs in transplant and regenerative medicine, he knows how.

The first strategy

Dr. Lott and his team at Mayo Clinic are a step ahead of the rest of the nation in giving people without a larynx new options.

Their first strategy is larynx transplant.

The procedure has only been performed three times in countries with advanced medicine.

Dr. Lott has established an exclusive set of protocols that helped create a new Head and Neck Transplantation Program at Mayo Clinic in Arizona. The United Network for Organ Sharing — the transplantation regulating organization — gave the protocols the green light so Dr. Lott and his team can perform two transplantations per year for the next five years. If all goes as the team expects, larynx transplant will become as routine as any other transplant such as heart, liver or kidney.

"Laryngeal transplantation will allow people to smell, taste, swallow and communicate in a voice uniquely one's own," Dr. Lott says. "It many cases, it can be lifesaving."

Larynx transplant could benefit about 60,000 people in the United States alone, but the procedure isn't without drawbacks. The first is organ availability. Like almost all transplantable organs, there just aren't enough to go around. The second is that not all laryngectomy patients would qualify for a larynx transplant. The third is that those who do have the procedure must immediately begin a regimen of immunosuppression drugs so their body doesn't attack the new organ. The drugs have to be taken every day for the rest of their lives, yet there still remains a chance of organ rejection.

Dr. Lott's second strategy of building a whole new organ, on demand, would overcome all of these drawbacks.

The second strategy

In the past few years, regenerative medicine has begun to deliver on the long promise of growing new organs from stem cells harvested from a patient's own body. Mayo Clinic will soon host a final-phase clinical trial that treats damaged heart muscle with stem cells harvested from bone marrow and treated with specific growth factors. It's just one of more than 40 clinical trials Mayo Clinic's Center for Regenerative Biotherapeutics is conducting.

The center is driving regenerative techniques throughout Mayo Clinic's research and practice by building an infrastructure that practitioners can use to apply to their own work. For instance, a researcher interested in applying stem cells to an eye disease can use center resources to extract cells, treat the cells with relevant growth factors, grow them into the necessary numbers for treatment and deliver them back to the patient. It reduces the learning curve from years to months. As a result, researchers can easily explore how regenerative medicine can help their patients.

Dr. Lott says there's little question that regenerative medicine will help his patients. In fact, he has already developed an implantable organ and is working with the Food and Drug Administration to launch a clinical trial by end of the year.

The process begins with highly accurate imaging of a person's larynx. Dr. Lott's team then uses 3-D printing to reconstruct the damaged portion of the organ. They use this as a mold to create a scaffold that will guide the stem cells as they grow. To get the stem cells, researchers take a sample of a person's fat tissue and transfer it to a specific medium in a culture dish. The fat cells float to the top and the stem cells sink to the bottom, making them easy to harvest. Researchers apply specific growth factors to begin transforming them into larynx cells and expand their numbers.

Once the scaffold and stem cells are ready, researchers place both in a bioreactor that rotates the scaffold through the culture media, much like a self-basting rotisserie. After two weeks, the tissue is ready for transplant.

The whole process is three to four weeks.

"Regenerative medicine enables us to reconstruct defects and restore function to tissue without the need for immunosuppression in ways that were previously unthinkable," Dr. Lott says. "This ability means that patients have fewer treatment risks, recover sooner, function better and have a better quality of life. In many cases, it preserves life itself."

Give patients back their voices by supporting Dr. Lott and Mayo Clinic's Center for Regenerative Biotherapeutics.

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