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Stem Cell Therapy

Bone Marrow Cells for Radiation-Induced Dry Mouth

Phase 1
Recruiting
Led By Randall 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months post-injection
Awards & highlights
No Placebo-Only Group

Summary

This trial studies MSCs injected into the salivary glands of people with head & neck cancer who had radiation therapy. Participants will donate marrow & saliva, get an ultrasound, & fill out questionnaires. Up to 30 months.

Who is the study for?
This trial is for adults aged 18-90 with dry mouth after radiation therapy for head and neck cancer. They must be at least 2 years post-treatment, in good health (Karnofsky score ≥70), able to undergo bone marrow collection under local anesthesia, have no current cancer signs, and can consent.
What is being tested?
The study tests the safety of injecting mesenchymal stem cells (MSCs) from patients' own bone marrow into their salivary glands to treat dry mouth caused by radiation. It includes collecting bone marrow, donating saliva, ultrasound exams, and questionnaires over a period of up to 30 months.
What are the potential side effects?
Potential side effects may include discomfort or complications from the bone marrow collection procedure and injection into the salivary glands. The full range of side effects related to MSC treatment will be studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 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
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
Safety and Tolerability: Number of Serious Adverse Events
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
+1 more
Secondary study objectives
Change in Quality of Life
Change in salivary production
Shear wave velocity with acoustic radiation force impulse

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: Mesenchymal Stem Cell (MSC) injectionExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MSC
2017
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,230 Previous Clinical Trials
3,199,795 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
306 Previous Clinical Trials
850,040 Total Patients Enrolled
Randall Kimple, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
~15 spots leftby Mar 2026
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