A Phase 1 interventional study of MSC in Head and Neck Cancer and Xerostomia, sponsored by University of Wisconsin, Madison. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Treatment
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:
Participants can expect to be in this study for up to 30 months.
There is no expanded access program available per this protocol.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 23 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: MSC
Injection of MSCs into submandibular glands at pre-specified dose level: * Dose -1: 5 (4 - 6) x10\^6 MSCs (to be used only if Dose level 1 is not tolerated) per gland (0.5 ml) * Dose 0: 10 (8 - 12) x10\^6 MSCs per gland (1 ml) * Dose 1: 20 (16 - 24) x10\^6 MSCs per gland (2 ml)
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Time frame: Up to 1 month post-injection
Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale
Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
Time frame: 1 month post-injection
Safety and Tolerability: Number of Serious Adverse Events
Incidence of any serious adverse event
Time frame: Up to 1 month post-injection
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
Incidence of pre-specified adverse events
Time frame: Up to 1 month post-injection
Change in Quality of Life
Efficacy of MSC assessed through University of Michigan Xerostomia Related Quality of Life (XeQOL) scale, which is a 15-item assessment scale with 4 domains. The score is the average of all responses of all domains and can range from 0 to 4, where higher scores indicate increased xerostomia burden.
Time frame: Baseline to 24 months post-injection
Change in Quality of Life
Efficacy of MSC assessed through the MD Anderson Dysphagia Index (MDADI), which is a 20-item questionnaire designed for evaluating the impact of dysphagia (swallowing ability). Scores range from 20 (extremely low functioning) to 100 (high functioning).
Time frame: Baseline to 24 months post-injection
Change in Quality of Life
Efficacy of MSC assessed through VAS xerostomia questionnaire, which is an 8-item questionnaire that measures the perception of dry mouth. Scores range from 0-10, with 0 being low dryness and 10 being high dryness.
Time frame: Baseline to 24 months post-injection
Change in salivary production
Saliva production will be measured by having participants chew inert gum base to the pace of a metronome (70 beats per minute) while expectorating saliva (without swallowing) into the saliva collection aid for 5 minutes total40. Cryovials will be weighed before and after collection and the difference in weight (g) will represent the amount of saliva produced in 5 minutes for each condition.
Time frame: Baseline to 24 months post-injection
Shear wave velocity with acoustic radiation force impulse
Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound
Time frame: 3, 6, and 12 months post-injection
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison