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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am between 18 and 90 years old.

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

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

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

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

Primary outcome measures

Percentage of Subjects Experiencing Dose Limiting Toxicity (DLT)

Secondary outcome measures

Change in Saliva Production Rate

Change in Salivary Gland Size

Change in Salivary Gland Stiffness Measured by Shear Wave Velocity

+8 more

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin Carbone Cancer Center (UWCCC)UNKNOWN

2 Previous Clinical Trials

32 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,192 Previous Clinical Trials

3,161,995 Total Patients Enrolled

National Institute of Dental and Craniofacial Research (NIDCR)NIH

300 Previous Clinical Trials

848,338 Total Patients Enrolled

Media Library

Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells (Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04489732 — Phase 1

Dry Mouth Research Study Groups: Treatment with MSCs

Dry Mouth Clinical Trial 2023: Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells Highlights & Side Effects. Trial Name: NCT04489732 — Phase 1

Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells (Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04489732 — Phase 1

Frequently Asked Questions

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

Is participation in this research limited to individuals of a certain age?

"To meet the requirements of this study, participants must be between 18 to 90 years in age. For younger patients, there are eighteen prospective trials while those over 65 can choose from 445 different studies."

Answered by AI

Is this a pioneering research effort?

"Since 2011, Autologous bone-marrow derived interferon gamma stimulated mesenchymal stromal cells has been under investigation. BioMérieux was the original sponsor of this research, and following a successful Phase 1 trial involving 20 patients, it quickly received approval for its official Phase 3 drug study. Currently there are 37 clinical trials in 19 different countries with 23 cities hosting these studies."

Answered by AI

Has the FDA sanctioned Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells for commercial use?

"Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells demonstrate low degree of safety according to our scale rating system; a score of 1 is attributed due to the limited amount of research available on their efficacy."

Answered by AI

What is the participation rate of this investigation?

"This research project is no longer accepting enrollees. It was first published on February 18th 2022, and the most recent update to its status occurred November 21st of that same year. For those looking for alternative studies in xerostomia, 413 trials are presently welcoming patients; 37 clinical trails also exist involving Autologous bone-marrow derived interferon gamma activated mesenchymal stromal cells actively searching for participants."

Answered by AI

Are there still open slots for this trial's participants?

"Per the clinicaltrials.gov website, this trial is not seeking participants at present. It was initially launched on February 18th 2022 and last revised on November 21st 2022. Despite that, there are currently 450 different studies actively recruiting patients for their trials."

Answered by AI