← Back to Search

Mesenchymal Stromal Cells

Stem Cell Therapy for Dry Mouth After Cancer Treatment

Phase 1

Waitlist Available

Led By Randall J Kimple, 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

Individuals at least 18 years of age and no older than 90 years of age

Xerostomia defined as less than or equal to 80 percent of baseline (pre-radiation) salivary function per patient estimate

Must not have

History of sialolithiasis

History of autoimmune diseases affecting salivary glands, including Sjögren's syndrome, lupus, scleroderma, type I diabetes, sarcoidosis, and amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if it is safe to use a person's own stem cells to help treat dry mouth after radiation therapy for head and neck cancer. Up to 12 people will be enrolled and the study will last up to 2 years.

Who is the study for?

This trial is for adults aged 18-90 with a history of head and neck cancer who are now disease-free for at least 2 years post-treatment. Participants must have significant dry mouth after radiation therapy, be able to give consent, undergo bone marrow biopsy under local anesthesia, and not be pregnant or planning pregnancy. Contraception use is required.

What is being tested?

The study tests the safety of using one's own modified bone marrow cells (MSCs) to treat severe dry mouth caused by radiation in head and neck cancer treatment. Up to 12 patients will receive this experimental therapy and will be monitored for up to two years.

What are the potential side effects?

Potential side effects may include discomfort or complications from the bone marrow biopsy procedure, reactions at the injection site, or immune responses due to infused MSCs. Specific side effects related to MSCs are still being studied.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 90 years old.

Select...

I believe my saliva production is less than 80% of what it was before radiation.

Select...

I can care for myself but may not be able to do active work.

Exclusion Criteria

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

Select...

I have had salivary gland stones in the past.

Select...

I have an autoimmune disease like Sjögren's, lupus, or type I diabetes.

Select...

I have chronic graft versus host disease.

Select...

I am not taking any anti-cholinergic medications.

Select...

I am not pregnant, breastfeeding, or planning to become pregnant during the study.

Select...

I have one submandibular gland.

Select...

I have untreated yeast infection in my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Subjects Experiencing Dose Limiting Toxicity (DLT)

Secondary study objectives

Change in Saliva Production Rate

Change in Salivary Gland Size

Change in Salivary Gland Stiffness Measured by Shear Wave Velocity

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with MSCsExperimental Treatment1 Intervention

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.

0 / 10Eligibility criteria met