RecruitingPhase 1NCT06392711

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

Sponsor

University of Wisconsin, Madison

Enrollment

36 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Conditions

Xerostomia

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

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting mesenchymal stromal cells (a type of stem cell) into the salivary glands can help people who have severe dry mouth (xerostomia) not caused by radiation therapy. Dry mouth can make it very hard to eat, speak, and swallow. **You may be eligible if...** - You are between 18 and 90 years old - You have been diagnosed with dry mouth (confirmed by a salivary flow test) that was NOT caused by radiation - Your overall health is adequate for a bone marrow aspirate procedure (to collect the stem cells) - Your blood counts, including hemoglobin and platelets, are within acceptable limits **You may NOT be eligible if...** - You are missing one of your submandibular (jaw) salivary glands - You have a salivary gland stone (sialolithiasis) - You have poorly controlled diabetes (HbA1c of 7% or higher) - You are taking diuretics believed to be causing your dry mouth - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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