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

NCT ID: NCT05820711

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2026-03-31

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.

Conditions

Head and Neck Cancer; Xerostomia

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesenchymal Stem Cell (MSC) injection

Group Type: EXPERIMENTAL

MSC

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall Kimple, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Jacques Galipeau, MD

Role: STUDY_DIRECTOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

UW21144

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/HUMAN ONCOLOGY/HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 9/13/2024

Identifier Type: OTHER

Identifier Source: secondary_id

4UH3DE030431-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0194

Identifier Type: -

Identifier Source: org_study_id