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Brief Title: Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
Official Title: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
Study ID: NCT05820711
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Name: Randall Kimple, MD, PhD
Affiliation: University of Wisconsin, Madison
Role: PRINCIPAL_INVESTIGATOR
Name: Jacques Galipeau, MD
Affiliation: University of Wisconsin, Madison
Role: STUDY_DIRECTOR