Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 90 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Ultrasound, Questionnaires, Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will: * have bone marrow collected using a needle * undergo a salivary gland ultrasound * complete questionnaires * receive an injection of the bone marrow cells into a salivary gland"
- "An initial cohort of subjects (n=6) will receive a unilateral injection of MSCs at dose level 0."
- "If unilateral treatment is tolerated, a dose escalation cohort (n=8-18) will receive bilateral injection of MSCs."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether bone marrow cells called mesenchymal stromal cells (MSCs) can safely help with dry mouth when injected into a saliva gland. It is for adults ages 18 to 90 whose dry mouth was not caused by radiation treatment. Participants will have bone marrow collected with a needle, an ultrasound of their saliva glands, questionnaires, and a cell injection.
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 gland ultrasound * complete questionnaires * receive an injection of the bone marrow cells into a salivary gland
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have dry mouth not caused by radiation treatment.
- Have a saliva test after diagnosis and before joining that shows less than 1.2 mL of saliva in 5 minutes without stimulation.
- Be 18 to 90 years old.
- Be able to care for yourself, with a Karnofsky daily activity score of at least 70, and be able to have bone marrow collected with numbing medicine while awake.
- Be willing and able to give consent to join.
- Have scans showing both saliva glands under the jaw.
- If able to become pregnant, have a negative pregnancy test. Men and women who could have a child must agree to use acceptable birth control.
- Have blood tests within 28 days before joining: hemoglobin at least 9 g/dL; platelets at least 100,000/µL; neutrophils at least 1,000/µL; and lymphocytes at least 800/µL. These measure oxygen-carrying protein, clotting cells, and infection-fighting cells. Blood clotting tests must be normal.
Who can't join
- Have only one saliva gland under the jaw, stones in a saliva gland, or an untreated yeast infection in the mouth.
- Have diabetes that is not well controlled, with an HbA1c blood sugar test of 7% or higher.
- Still take a diuretic (water pill) started before dry mouth began, if the referring provider thinks it causes the dryness.
- Have had cancer in the past 2 years. Exceptions include adequately treated stage I lung cancer, non-melanoma skin cancer, DCIS (cancer inside breast milk ducts), or stage I cervical cancer; and low-risk prostate cancer that was treated or is being closely watched.
- Take medicines that weaken the immune system without a stable dose for at least 2 months. Dose changes based on drug levels in the blood are allowed.
- Need regular blood transfusions, or have an expected lifespan of 6 months or less, as judged by the study doctor.
- Have used an experimental drug, biological treatment, or device within 30 days before joining; or be in another study that could affect this study's results.
- Be pregnant, breastfeeding, or planning pregnancy during the study; or be judged unsuitable for other reasons by the study team.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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
Study sites (1)
WI
- University of Wisconsin · Madison, WI 53705Cancer Connect · Study contact · 800-622-8922 · clinicaltrials@cancer.wisc.eduMore trials in Madison