Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Wisconsin, Madison
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 gland ultrasound * complete questionnaires * receive an injection of the bone marrow cells into a salivary gland
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mesenchymal Stromal Cells (MSC) Dose Level 0
- Mesenchymal Stromal Cells (MSC) Dose Level 1
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov