← Back to Search

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months post-injection

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in Quality of Life

Change in salivary production

Shear wave velocity with acoustic radiation force impulse

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

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,501 Total Patients Enrolled

National Institute of Dental and Craniofacial Research (NIDCR)NIH

300 Previous Clinical Trials

848,314 Total Patients Enrolled

Randall Kimple, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for inclusion in this experiment limited to individuals aged fifty or below?

"This investigation has set forth a range of 18-90 years old as its inclusion criteria. For those outside this age group, there are 19 clinical trials for minors and 505 studies open to senior citizens."

Answered by AI

What are the potential risks of receiving an injection with Mesenchymal Stem Cells (MSCs)?

"The safety of MSC injection was assessed by our team at Power and it received a score of 1; this rating reflects the limited data available on its efficacy, as this is only in the initial stage of clinical trials."

Answered by AI

Is there a way for me to take part in this research effort?

"This clinical trial is currently recruiting up to 30 individuals who suffer from dry mouth and are between the ages of 18-90."

Answered by AI

Are any additional participants still being enrolled in this clinical trial?

"As per information listed on clinicaltrials.gov, this particular trial is not actively seeking candidates at the moment. The study was initially published on May 1st 2023 and last amended April 6th of the same year. Though it is not currently looking for participants, there are presently 508 other trials that require enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy

2023. "Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05820711.