The University of Wisconsin Carbone Cancer Center has the go-ahead to start clinical trials on a first-in-human cell therapy to treat a common side effect of radiation therapy.

This investigational new drug license, or IND, recently issued by the Food and Drug Administration will allow UW oncologists to study a new cell therapy to treat radiotherapy-induced xerostomia, also called dry mouth.

The new IND offers an entirely novel use of personalized cell therapy with the patient’s own interferon-gamma activated marrow stromal cells, according to Jacques Galipeau, MD, associate dean for therapeutics development and director of the UW Program for Advanced Cell Therapy.

Carbone Cancer Center laboratory
Cell manufacturing for the forthcoming clinical trials will take place at the Program for Advanced Cell Therapy's pharmaceutical-grade facilities located at University Hospital.

“This will be the first use of immune activated cell therapy of its kind in the world, and the application to treat radiotherapy-induced xerostomia is the first in U.S.,” he said. “This is an entirely UW homespun technology, manufactured within UW Health’s pharmaceutical grade facilities, and deployed through University of Wisconsin School of Medicine and Public Health faculty affiliated with Carbone Cancer Center.”

This Phase 1 trial will be enrolling up to 30 patients to show the cell therapy is safe and promising for effectiveness, and will be solely conducted at the School of Medicine and Public Health in partnership with UW Health. The trial will be led by Randy Kimple, MD, PhD, associate professor of human oncology and a nationally recognized clinical expert in head and neck radiation therapy.

Randy Kimple
Randy Kimple

“We will begin recruiting patients in the near future, and hope to conclude the first phase of the trial within a year,” Kimple said.

Xerostomia is one of the most critical long-term side effects of radiation therapy for head and neck cancer. It can result in problems eating, speaking and sleeping, in addition to causing pain, fatigue and contributing to tooth decay.

“There is a critical need for improved treatments for this condition,” Kimple said. “For most patients the best care we can provide currently is to encourage them to eat specially prepared food, suck on hard sugar-free candies and carry a water bottle with them all day.”

The preliminary work enabling this study has been supported by a National Cancer Institute SPORE grant, and by The Ride.

“This is the future of translational research at academic centers, where we can better control the entire value trajectory from discovery to first-in-human deployment and beyond,” said Howard Bailey, director of the UW Carbone Cancer Center. “This bold approach embodies the modern version of the Wisconsin Idea.”