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New Phase I clinical trial protocol submitted to FDA to treat subjects with xerostomia after XRT for Head and Neck Cancer using “fresh” interferon-γ activated MSCs at UW Health

A new clinical trial protocol to be covered under an investigator-sponsored IND held by UW Program for Advanced for Advanced Cell Therapy was submitted to the FDA this week. Randall Kimple MD, PhD, UW Associate Professor of Human Oncology is the Principal Investigator of the new protocol titled, “A Phase I Dose Escalation Trial of Mesenchymal Stromal Cells in Patients with Xerostomia after radiation therapy for Head and Neck Cancer”.  Following a pilot safety study where autologous interferon-γ activated MSCs were injected in a single submandibular gland (NCT04489732), in this phase I clinical trial, MSCs will be injected into both submandibular glands. Posting of this clinical trial at will occur following the requisite regulatory approvals. Accrual of 30 subjects at the UW Carbone Cancer Center is anticipated to begin in the second quarter of 2023.