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Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
Sponsor: University of Wisconsin, Madison
Summary
The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands. Participants will have head and neck cancer that was treated with radiation therapy, and in this study will: * Undergo a collection of bone marrow using a needle; * Donate saliva; * Undergo a salivary gland ultrasound; and, * Complete questionnaires that ask about dry mouth Participants can expect to be in this study for up to 30 months. There is no expanded access program available per this protocol.
Official title: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2023-07-17
Completion Date
2028-01
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
MSC
Injection of MSCs into submandibular glands at pre-specified dose level: * Dose -1: 5 (4 - 6) x10\^6 MSCs (to be used only if Dose level 1 is not tolerated) per gland (0.5 ml) * Dose 0: 10 (8 - 12) x10\^6 MSCs per gland (1 ml) * Dose 1: 20 (16 - 24) x10\^6 MSCs per gland (2 ml)
Locations (1)
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States