FDA clears IND application for cell therapy to treat radiotherapy-induced dry mouth
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The FDA cleared an investigational new drug application for a mesenchymal stromal cell therapy to treat radiotherapy-induced xerostomia, also known as dry mouth.
Researchers at University of Wisconsin Carbone Cancer Center developed the therapy, which uses the patient’s interferon-gamma activated marrow stromal cells.
Xerostomia is a one of the most common adverse effects of radiation therapy for head and neck cancers and may cause difficulties eating, speaking and sleeping, in addition to oral health complications.
“There is a critical need for improved treatments for this condition,” Randy Kimple, MD, PhD, associate professor of human oncology at University of Wisconsin School of Medicine, said in a press release. “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.”
Kimple told Healio the therapy process involves the patient undergoing a bone marrow biopsy to harvest mesenchymal stromal cells.
Kimple — who will lead the forthcoming phase 1 trial for the therapy — said the cells will be prepared by the Program for Advanced Cell Therapy's lab at UW Health's University Hospital. Patients will receive the therapy via injection into the submandibular gland after completion of radiation therapy.
The phase 1 trial soon will begin enrolling up to 30 patients and will be conducted by University of Wisconsin School of Medicine and Public Health as a single-center study of patients treated at Carbone Cancer Center.
Study participants will be monitored for safety and development of adverse effects after receiving the cell therapy injection.
“Patients will also provide samples of their saliva and complete quality-of-life questionnaires to help determine if the treatment is effective,” Kimple said.
Researchers hope to complete the first phase of the trial within a year, according to Kimple.
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