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

NCT05820711 | Active Not Recruiting Phase 1 DMC FDA Drug

• 6 other identifiers: 2023-0194UW21144SMPH/HUMAN ONCOLOGY/HUMAN ONCOProtocol Version 9/13/20244UH3DE030431-02A533300
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  1 month post-injection

• Safety and Tolerability: Number of Serious Adverse Events

  Incidence of any serious adverse event

  Up to 1 month post-injection

• Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events

  Incidence of pre-specified adverse events

  Up to 1 month post-injection

Secondary Outcomes (5)

• Change in Quality of Life

  Baseline to 24 months post-injection

• Change in Quality of Life

  Baseline to 24 months post-injection

• Change in Quality of Life

  Baseline to 24 months post-injection

• Change in salivary production

  Baseline to 24 months post-injection

• Shear wave velocity with acoustic radiation force impulse

  3, 6, and 12 months post-injection

Study Arms (1)

Mesenchymal Stem Cell (MSC) injection

EXPERIMENTAL

Drug: MSC

Interventions

MSC 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)

Mesenchymal Stem Cell (MSC) injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Randall Kimple, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Jacques Galipeau, MD

  University of Wisconsin, Madison

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 20, 2023
• Study Start: July 17, 2023
• Primary Completion: December 9, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)