drugset / Trial / NCT05820711
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
Phase 1
Active not recruiting
23 enrolled
University of Wisconsin, Madison
National Institute of Dental and Craniofacial Research (NIDCR) · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-17
- Primary completion
- 2025-12-09
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 5 cells | Other |
| Subject | mesenchymal stem cells | Cell therapy | 10 cells | Other |
| Subject | mesenchymal stem cells | Cell therapy | 20 cells | Other |