drugset / Trial / NCT05820711

Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy

NCT05820711

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

EvaluationDrugModalityDoseRoute
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

Indications