Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients with Medical Xerostomia

Launched by UNIVERSITY OF WISCONSIN, MADISON · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with a condition called medical xerostomia, which means having a dry mouth not caused by radiation therapy. The researchers want to find out if injecting special cells from bone marrow, called mesenchymal stromal cells (MSCs), into the salivary glands can help improve this dryness. Participants will go through a process that includes collecting bone marrow using a needle, having an ultrasound of their salivary glands, and filling out some questionnaires before receiving the MSC injection.

To be eligible for the trial, participants need to be between 18 and 90 years old and have a specific level of salivary flow, indicating dry mouth. They should also have certain health conditions like Sjögren's Disease or graft-versus-host disease. If you join the trial, you will be monitored for how well you tolerate the treatment and whether it helps with your dry mouth. This trial is currently recruiting participants, and it is important to know that there are some health criteria that might exclude someone from participating, which the research team can explain in detail.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Xerostomia, defined as an unstimulated salivary flow of less than or equal to 0.5 mL in 5 minutes
• • Xerostomia not resulting from radiotherapy (medical xerostomia) defined as an unstimulated salivary flow ≤0.5 mL/5 minutes documented at any time following Xerostomia diagnosis and prior to enrollment.
• • ≥ 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 42 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 or ESRD
• • 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