This phase I trial studies the side effects, best dose, and effect of mesenchymal stem cells in treating radiation-induced dry mouth (xerostomia) in patients with head and neck cancer. Patients with head and neck cancer who have radiation treatment often have damage to their salivary glands. This damage leads to xerostomia, which can result in impaired swallowing ability, difficulty speaking, diminished taste, and more cavities in teeth. Mesenchymal stem cells are produced in the bone marrow. Injection of mesenchymal stem cells into salivary glands may help reduce xerostomia by promoting healing and increasing saliva production.
Additional locations may be listed on ClinicalTrials.gov for NCT04489732.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of mesenchymal stem cells (MSCs) for subjects with xerostomia after radiation for head and neck cancer (HNC).
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of MSCs for treatment of xerostomia and salivary hypofunction.
II. To assess the imaging characteristics of submandibular gland after MSC injection.
III. To assess the feasibility of a future phase 1 dose-escalation study.
OUTLINE:
Patients undergo bone marrow biopsy and then receive MSCs via injection into submandibular gland(s) on day 1 in the absence of unacceptable toxicity. Patients may also receive additional MSCs via injection submandibular gland(s). Patients also undergo bone marrow aspiration on study, and undergo ultrasound and collection of blood samples at baseline and follow up.
After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 24 months.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorRandall J. Kimple
