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ACTIVE NOT RECRUITING
NCT04489732
PHASE1

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

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

Official title: Pilot Study of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2022-02-18

Completion Date

2026-05

Last Updated

2026-04-08

Healthy Volunteers

No

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States