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Active, Not Recruiting

NCT Number: NCT05820711

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Primary outcomes

  1. Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)

    Time frame: 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)

  2. Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale

    Time frame: 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)

  3. Safety and Tolerability: Number of Serious Adverse Events

    Time frame: Up to 1 month post-injection

    Incidence of any serious adverse event

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

    Time frame: Up to 1 month post-injection

    Incidence of pre-specified adverse events

Secondary outcomes

  1. Change in Quality of Life

    Time frame: Baseline to 24 months post-injection

    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.

  2. Change in Quality of Life

    Time frame: Baseline to 24 months post-injection

    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).

  3. Change in Quality of Life

    Time frame: 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.

  4. Change in salivary production

    Time frame: 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.

  5. Shear wave velocity with acoustic radiation force impulse

    Time frame: 3, 6, and 12 months post-injection

    Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Apr 20, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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