A Pilot, First in Human Study of Autologous IFN-Gamma Stimulated Mesenchymal Stromal Cells for Treatment of Radiation -Induced Xerostomia

Injection of autologous IFNγ-stimulated MSC(M) into the submandibular gland of patients with RIX is safe and well tolerated. A trend towards an improvement in secondary endpoints of salivary quantity and quality of life was observed. This first-in-human pilot study provides support for further investigation into IFNγ-stimulated MSC(M) as an innovative, potentially curative, remedy to treat RIX. A phase I dose-escalation study injecting into bilateral submandibular glands is scheduled to begin accrual in the spring of 2023.