Stem Cell Therapy for Dry Mouth After Cancer Treatment

Recruiting in Palo Alto (17 mi)

Overseen by Randall J Kimple, MD,PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single center pilot study designed to determine the safety and tolerability of autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12 participants will be enrolled and can expect to be on study for up to 2 years.

Research Team

Randall J Kimple, MD,PhD

Principal Investigator

University of Wisconsin, Madison

Jacques Galipeau, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

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

I have confirmed I am not pregnant and will use birth control during and after the study.

I am between 18 and 90 years old.

Exclusion Criteria

I haven't had cancer in the past 2 years, except for certain low-risk or treated early-stage cancers.

The researchers have decided that you are not suitable to participate in the study for other reasons.

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

Treatment Details

Interventions

• Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells (Mesenchymal Stromal Cells)

Trial Overview 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.

Participant Groups

Group I: Treatment with MSCs Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

University of Wisconsin Carbone Cancer Center (UWCCC)

Collaborator

Trials

3

Recruited

20+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Janice S. Lee

National Institute of Dental and Craniofacial Research (NIDCR)

Clinical Director

DDS, MD, MS

Jennifer Webster-Cyriaque

National Institute of Dental and Craniofacial Research (NIDCR)

Acting Director

DDS, PhD