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

Phase 1

Recruiting

• Conditions: Xerostomia; Head and Neck Cancer
• Interventions: Drug: MSC

• Registration Number: NCT05820711
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-20
• Study Start: 2023-07-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stem Cell (MSC) injection	MSC	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events	Up to 1 month post-injection	Incidence of pre-specified adverse events
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)	Up to 1 month post-injection	RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale	1 month post-injection	Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
Safety and Tolerability: Number of Serious Adverse Events	Up to 1 month post-injection	Incidence of any serious adverse event

Secondary Outcome Measures

Name	Time	Method
Shear wave velocity with acoustic radiation force impulse	3, 6, and 12 months post-injection	Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound
Change in Quality of Life	Baseline to 24 months post-injection	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.
Change in salivary production	Baseline to 24 months post-injection	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.

Trial Locations

Locations (1)

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States