Recruiting
Phase 1

Mesenchymal Stromal Cells

Sponsor:

University of Wisconsin, Madison

Code:

NCT06392711

Conditions

Xerostomia

Graft-versus-host-disease

Sjogren's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mesenchymal Stromal Cells (MSC) Dose Level 0

Mesenchymal Stromal Cells (MSC) Dose Level 1

Study Details

Brief summary:

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

Conditions

Xerostomia

Graft-versus-host-disease

Sjogren's Disease

Study ID

NCT06392711

Start date

Oct 4, 2024

Status verified date

Jun, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: MSCs Dose Level 0 into one submandibular gland

6 subjects will receive Mesenchymal Stromal Cells (MSC) at Dose Level 0, which is 10 (8-12) x10\^6 MSCs in a single submandibular gland. If this dose is deemed tolerable when injected into a single submandibular gland, this dose will be administered to both submandibular glands in the initial subjects in the dose escalation arm.

active comparator: MSCs into both submandibular glands - Dose Escalation Cohort

8-18 subjects in the Dose Escalation phase of study will receive MSCs into both submandibular glands. The initial subjects in this cohort will receive Dose Level 0: 10 (8-12) x10\^6 MSCs/gland. If this dose is tolerated, subsequent subjects will receive Dose Level 1: 20 (16-24) x10\^6 MSCs/gland. The highest tolerated dose (recommended phase II dose or RP2D) will be administered to the subjects in the Expansion Cohort.

active comparator: MSCs into both submandibular glands - Expansion Cohort

12 subjects in Expansion Cohort will receive MSCs into both submandibular glands at the RP2D.

Interventions

Mesenchymal Stromal Cells (MSC) Dose Level 0

10 (8-12) x 10\^6 MSCs

Mesenchymal Stromal Cells (MSC) Dose Level 1

20 (16-24) x 10\^6

Primary outcome measure

  • Proportion of participants experiencing DLT of submandibular pain [ Time Frame: 1 month post-injection ]
  • Proportion of participants experiencing DLT as serious adverse events (AEs) [ Time Frame: 1 month post-injection ]
  • Proportion of participants experiencing DLT as pre-specified toxicities [ Time Frame: 1 month post-injection ]

Central Contacts and Locations

Central contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 19, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-19.