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MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer

NCT04489732 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-08

Study results available
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Summary

This is a single center pilot study designed to determine the safety and tolerability of autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12 participants will be enrolled and can expect to be on study for up to 2 years.

Conditions

  • Xerostomia Following Radiotherapy

Interventions

BIOLOGICAL

Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells

Single dose, starting at * Dose Level 0: 10 (8-12) x 10\^6 injected into one submandibular gland on Day 1 Sub-study for second injection after primary objectives met, 10 (8 - 12) x 10\^6 MSCs will be offered for injection into each participant's contralateral submandibular gland

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

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

  • Jacques Galipeau, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2022-11-22
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04489732 on ClinicalTrials.gov