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

Launched by UNIVERSITY OF WISCONSIN, MADISON · Apr 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people who have dry mouth (xerostomia) after receiving radiation therapy for head and neck cancer. The researchers want to see if injecting special cells called mesenchymal stem cells (MSCs), which are taken from your own bone marrow, into the salivary glands can improve saliva production and relieve dry mouth symptoms.

To participate, you need to be between 18 and 90 years old, have a history of head and neck cancer treated with radiation, and currently experience dry mouth. If you decide to join, you'll undergo a procedure to collect bone marrow using a needle, provide saliva samples, have an ultrasound of your salivary glands, and fill out some questionnaires about your dry mouth. The study will last up to 30 months, and participants will be closely monitored to ensure their safety and comfort throughout the process. If you're interested, the study is currently recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED)
• • Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation)
• • ≥ 18 years of age, ≤ 90 years of age.
• • Patients ≥ 2 years from completion of radiation therapy for HNC
• • Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
• • Willing and able to give informed consent
• • Radiographically confirmed submandibular gland(s)
• Exclusion Criteria:
• • Salivary gland disease (i.e., sialolithiasis)