Mesenchymal Stromal Cells for Dry Mouth Relief (NCT06392711)

At a Glance

Age: 18 – 90
Sex: Any
Trial phase: Phase 1
Study type: Interventional
Purpose: Treatment
Participants needed: 36 (estimated)
Sponsor: University of Wisconsin, Madison · Other

Who this trial is looking for

This trial is looking for adults with a dry mouth condition called xerostomia. Participants will undergo a bone marrow collection and receive an injection of special cells into their salivary glands to see if it helps improve their symptoms.

Are You a Good Fit for This Trial?

You may be able to join if

I have been diagnosed with xerostomia.
I am between 18 and 90 years old.
I can provide informed consent.
I have confirmed issues with both submandibular glands.
I have a salivary flow less than 1.2 mL in 5 minutes.
I do not have xerostomia from radiation treatment.
I am willing to use contraception if I can become pregnant.
My blood tests meet the study requirements.

You may not be able to join if

I have one submandibular gland.
I have poorly-controlled diabetes.
I have had cancer in the last 2 years, except for some certain types.
I am pregnant or breastfeeding, or plan to be during the study.
I am dependent on blood transfusions.
I am currently enrolled in another clinical study that might affect this one.
I have untreated oral infections.
I am using investigational treatments right now.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

About This Trial

The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth. Participants will: * have bone marrow collected using a needle * undergo a salivary…

Trial Locations

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Eligibility Criteria

Inclusion Criteria: * Xerostomia, defined as an unstimulated salivary flow \<1.2 mL in 5 minutes documented at any time following xerostomia diagnosis and prior to enrollment * Xerostomia not resulting from radiotherapy (medical xerostomia) * ≥ 18 years of age, ≤ 90 years of age * Karnofsky perform…

Inclusion Criteria: * Xerostomia, defined as an unstimulated salivary flow \<1.2 mL in 5 minutes documented at any time following xerostomia diagnosis and prior to enrollment * Xerostomia not resulting from radiotherapy (medical xerostomia) * ≥ 18 years of age, ≤ 90 years of age * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia * Willing and able to give informed consent * Radiographically confirmed bilateral submandibular glands * If female of childbearing potential, negative pregnancy test * Males and females of childbearing potential willing to use acceptable contraception * Laboratory Values (within 28 calendar days of enrollment): * Hgb ≥ 9 g/dL (5.58 mmol/L) * Platelets ≥ 100,000/µL * ANC ≥ 1000/µL * Lymphocytes ≥ 800/µL * PT/INR and PTT within normal limits based on age/sex Exclusion Criteria: * Patients with one submandibular gland * Sialolithiasis * Poorly-controlled diabetes mellitus (HbA1c ≥ 7%) * Patients who initiated any diuretic therapy before developing dry mouth symptoms and are still on diuretic therapy and the referring provider believes the dryness symptoms are driven by diuretic use * Untreated oral candidiasis based on physical exam at enrollment * Malignancy within the last 2 years (except adequately treated stage I lung cancer, low risk prostate cancer that has been treated or is undergoing active surveillance, adequately treated non-melanoma skin cancer, adequately treated DCIS, or adequately treated stage I cervical cancer) * For patients on immunosuppressive therapy, must be on stable dose of immunosuppressive therapy for at least 2 months, allowing for dose adjustments for blood levels of drugs * Transfusion dependency * Life expectancy ≤ 6 months as determined by the investigator * Use of investigational drugs, biologics, or devices within 30 calendar days prior to enrollment * Pregnant or lactating women or those who plan to become pregnant during the study * Not suitable for study participation due to other reasons at discretion of investigators. * Enrollment in another clinical study possibly interfering with the endpoints of this study

Contacts

Cancer Connect

800-622-8922

clinicaltrials@cancer.wisc.edu

CONTACT

Mesenchymal Stromal Cells for Dry Mouth Relief

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