Phase I Study of Safety and Dose Levels of Mesenchymal Stromal Cells Injected into Salivary Glands to Treat Medical Dry Mouth

What this Trial Is About

Researchers are evaluating the safety and tolerability of injecting mesenchymal stromal cells MSCs derived from bone marrow into the salivary glands of patients with medical xerostomia, a condition characterized by dry mouth often caused by inflammatory diseases such as Sjf6grens disease or graft-versus-host disease. This phase I, open-label, dose-escalation study aims to determine if these injections lead to any improvement in dry mouth symptoms. Participants will first undergo bone marrow aspiration to collect MSCs. The study includes an initial group receiving a unilateral MSC injection at Dose Level 0, followed by a dose escalation phase where participants receive bilateral injections at increasing doses if tolerated. Finally, an expansion cohort will receive the recommended dose determined by earlier phases. Injections are given under local anesthesia into the submandibular glands. Throughout the study, participants will have ultrasounds of their salivary glands, complete questionnaires about their symptoms, and have their salivary function tested at multiple time points up to 24 months. Researchers will monitor adverse events, salivary production rates, saliva composition, and xerostomia scores to assess safety and possible benefits. The total study duration allows for long-term follow-up after treatment.

Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia