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Cell Therapy

Mesenchymal Stromal Cells for Dry Mouth

Phase 1

Recruiting

Led By Sara McCoy, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Xerostomia not resulting from radiotherapy (e.g., Sjögren's Disease or Graft versus Host Disease)

Age between 18 and 90 years

Must not have

Transfusion dependency

Sialolithiasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 moths, 6 months, 12 months, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if injecting a type of cells called mesenchymal stromal cells (MSCs), produced in your bone marrow, into your salivary glands can help improve dry

Who is the study for?

This trial is for individuals with dry mouth due to conditions like Graft-versus-Host Disease or Sjögren's Syndrome. Participants will have bone marrow collected, undergo an ultrasound of their salivary glands, fill out questionnaires, and receive an injection of their own bone marrow cells into a salivary gland.

What is being tested?

The trial is testing the safety and potential benefits of injecting mesenchymal stromal cells (MSCs) at two different dose levels directly into the salivary glands to see if it can improve symptoms of dry mouth in patients.

What are the potential side effects?

Potential side effects may include discomfort or pain at the bone marrow collection site or injection site, swelling or infection in the salivary glands, and general reactions such as fever or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have dry mouth not caused by radiation treatment.

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I am between 18 and 90 years old.

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I produce less than or equal to 0.5 mL of saliva in 5 minutes without stimulation.

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I am mostly independent and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need regular blood transfusions.

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I have a salivary gland stone.

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I have one submandibular gland.

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My diabetes is not well-managed (HBA1c is 7% or higher).

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I have untreated oral candidiasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 moths, 6 months, 12 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 moths, 6 months, 12 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 moths, 6 months, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants experiencing DLT as pre-specified toxicities

Proportion of participants experiencing DLT as serious adverse events (AEs)

Proportion of participants experiencing DLT of submandibular pain

Secondary study objectives

Change in salivary function-rate of salivary production

Change in salivary function-saliva composition

Change in xerostomia scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: MSCs Dose Level 0 into one submandibular glandActive Control1 Intervention

6 subjects will receive Mesenchymal Stromal Cells (MSC) at Dose Level 0, which is 10 (8-12) x10\^6 MSCs in a single submandibular gland. If this dose is deemed tolerable when injected into a single submandibular gland, this dose will be administered to both submandibular glands in the initial subjects in the dose escalation arm.

Group II: MSCs into both submandibular glands - Dose Escalation CohortActive Control2 Interventions

8-18 subjects in the Dose Escalation phase of study will receive MSCs into both submandibular glands. The initial subjects in this cohort will receive Dose Level 0: 10 (8-12) x10\^6 MSCs/gland. If this dose is tolerated, subsequent subjects will receive Dose Level 1: 20 (16-24) x10\^6 MSCs/gland. The highest tolerated dose (recommended phase II dose or RP2D) will be administered to the subjects in the Expansion Cohort.

Group III: MSCs into both submandibular glands - Expansion CohortActive Control2 Interventions

12 subjects in Expansion Cohort will receive MSCs into both submandibular glands at the RP2D.

0 / 9Eligibility criteria met