NCT06392711

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

UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Detailed description

This single-center phase I dose-escalation with expansion cohort, open label, non-randomized, non-placebo controlled, single group assignment study will assess the safety and tolerability of mesenchymal stromal cells (MSCs) for treatment of xerostomia, focusing on xerostomia with inflammatory etiology (e.g., Sjögren's disease \[SjD\], graft-versus-host disease \[GVHD\]). An initial cohort of subjects (n=6) will receive a unilateral injection of MSCs at dose level 0. If unilateral treatment is tolerated, a dose escalation cohort (n=8-18) will receive bilateral injection of MSCs. Dose escalation will proceed using a standard 3+3 design and once the recommended phase II dose (RP2D) is defined, 12 additional patients will be accrued to the expansion phase. Following the completion of screening/baseline procedures, eligible participants will undergo bone marrow aspiration in order to obtain MSCs. The MSC investigational product will be injected into one or both submandibular glands under local anesthesia at the interventional visit.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-04
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-04-30
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study