Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia

Completed · Not applicable

Conditions studied: Xerostomia, Head and Neck Cancer

In brief

Xerostomia, or dry mouth, is a common side effect of head neck radiation. Current treatment options for radiation-induced xerostomia are generally supportive in nature. Most of these supportive interventions do not reverse xerostomia and are palliative in intent. The investigators propose that autotransplantation of marrow-derived mesenchymal stromal cells (MSCs) in salivary glands post-RT or post-chemoradiation therapy (CRT) may provide an innovative remedy to treat xerostomia and restore quality of life. Participants can expect to be on study for up to 6 months.

Key facts

Study ID

NCT04007081

Run by

University of Wisconsin, Madison

People needed

12

Starts

2019-10-18

Expected to finish

2021-03-10

Last updated by the study team

2021-03-24

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants ≥2 years from completion of chemoradiation therapy or radiation therapy (N=6) with subjective complaint of xerostomia or with no diagnosis of HNC (N=5)
• Karnofsky ≥ 60, participant eligible for bone marrow aspirate with wakeful anesthesia
• Not pregnant
• Willing and able to give informed consent
• non-HNC participants only need to meet the following applicable inclusion criteria
• No history of radiation to the salivary glands
• Willing and able to give informed consent

You may not qualify if…

• Salivary gland disease (e.g., sialolithiasis)

Where it is running

• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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