The California Institute for Regenerative Medicine (CIRM) is investing more than $11 million to fund a UC Davis clinical trial testing a cell therapy to help throat cancer patients heal from the devastating effects of radiation therapy. The phase II trial is being conducted by otolaryngology (ear, nose and throat) professor Peter Belafsky, who is also director of the UC Davis Health Center for Voice and Swallowing.
Every year more than 65,000 Americans are diagnosed and treated for head and neck cancer, according to the National Institute of Dental and Craniofacial Research. One devastating and debilitating side effect of the treatment is dysphagia, or difficulty swallowing.
Belafsky and his team are developing a therapeutic approach using autologous muscle-derived progenitor cells (AMDC) obtained from a biopsy of the patient’s own muscle elsewhere in the body. Progenitor cells, which are derived from stem cells, can produce specialized cell types. Autologous stem cell transplantation is a procedure in which the patient’s own healthy stem cells are used to replace stem cells that radiation or chemotherapy have damaged. The healthy cells are injected into the tongue of the patient, where they fuse with existing muscle fibers to increase tongue strength and ability to swallow.
“This is a potential game-changer for the countless cancer survivors living with the consequences of radiation toxicity,” Belafsky said. “This is an incredible win for our team at UC Davis and our patients who have been in relentless pursuit of a ‘cure for the cure.’”
Patients with head and neck cancer often undergo surgery and/or radiation to remove tumors. As a result, they may develop problems swallowing, which can lead to serious complications, such as malnutrition, dehydration, social isolation or a dependence on using a feeding tube. Patients also are subject to inhaling food or liquids into their lungs, causing infections, pneumonia and possibly death. The only effective therapy is a total laryngectomy — removal of the larynx (voice box), leaving the person unable to speak.
“Dysphagia is not only a serious problem for people recovering from head and neck cancer, it’s also a problem for millions of older Americans,” says Maria T. Millan, president and CEO of CIRM. “This approach has the potential to make life better for millions of Californians who are experiencing swallowing disorders but have no effective treatment options.”
With $5.5 billion in funding and more than 150 active stem cell programs in its portfolio, CIRM is one of the world’s largest institutions dedicated to cellular medicine, currently funding more than 80 clinical trials.
