Xerostomia study: Mesenchymal Stromal Cells
Official title Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
ClinicalTrials.gov ID: NCT06392711
What this study is testing
What is Mesenchymal Stromal Cells (MSC) Dose Level 0?
This is an investigational cell therapy being studied to see if it helps with dry mouth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if injecting special cells from bone marrow into the salivary glands is safe and if it helps improve dry mouth.
- Who it's for
- People who have dry mouth caused by conditions like Sjogren's disease or graft-versus-host disease.
- What's involved
- Participants will have bone marrow collected, get an ultrasound of their salivary glands, fill out questionnaires, and receive an injection of the cells into a salivary gland.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Xerostomia, defined as an unstimulated salivary flow \<1.2 mL in 5 minutes documented at any time following xerostomia diagnosis and prior to...
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Madison, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.