MedTrace Logo

Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

NCT06392711 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-02-10

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth.

Participants will:

* have bone marrow collected using a needle
* undergo a salivary gland ultrasound
* complete questionnaires
* receive an injection of the bone marrow cells into a salivary gland

Conditions

  • Xerostomia
  • Graft-versus-host-disease
  • Sjogren's Disease

Interventions

BIOLOGICAL

Mesenchymal Stromal Cells (MSC) Dose Level 0

10 (8-12) x 10\^6 MSCs

BIOLOGICAL

Mesenchymal Stromal Cells (MSC) Dose Level 1

20 (16-24) x 10\^6

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Sara McCoy, MD, PhD · University of Wisconsin, Madison

  • Jacques Galipeau, MD · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06392711 on ClinicalTrials.gov