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

NCT05820711 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-02-09

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Randall Kimple, MD, PhD · University of Wisconsin, Madison

  • Jacques Galipeau, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2025-12-09
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05820711 on ClinicalTrials.gov