CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled / 6 target
Drug / intervention
Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04489732
NCT04489732Phase 1CompletedUpdate Overdue (0.1/mo)Completion was 43mo ago
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Pilot Study of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer

University of Wisconsin, Madison·interventional·Posted Jul 28, 2020·Updated Jun 24, 2026

In Brief

A Phase 1 clinical trial evaluating Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells for Xerostomia Following Radiotherapy. Completed, enrolled 6 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsXerostomia Following Radiotherapy
CountriesUnited States
CollaboratorsNational Institute of Dental and Craniofacial Research (NIDCR)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 28, 2020
Enrollment StartFeb 18, 2022
Primary CompletionNov 22, 2022
Study CompletionMay 20, 2026
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.9 years ago

Arms & Interventions

Treatment with MSCsexperimental

A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia (primary objective) Following primary outcomes, a second injection of 10 (8 - 12) x 106 MSCs will be offered for injection into each participant's contralateral submandibular gland.

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

Interventions

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

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