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NCT06392711 | RECRUITING | Xerostomia

Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Sponsor:

University of Wisconsin, Madison

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

Condition or disease

Xerostomia

Graft-versus-host-disease

Sjogren's Disease

Intervention/treatment

Mesenchymal Stromal Cells (MSC) Dose Level 0

Mesenchymal Stromal Cells (MSC) Dose Level 1

Phase

PHASE1

Detailed Description:

This single-center phase I dose-escalation with expansion cohort, open label, non-randomized, non-placebo controlled, single group assignment study will assess the safety and tolerability of mesenchymal stromal cells (MSCs) for treatment of xerostomia, focusing on xerostomia with inflammatory etiology (e.g., Sjögren's disease \[SjD\], graft-versus-host disease \[GVHD\]). 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. Dose escalation will proceed using a standard 3+3 design and once the recommended phase II dose (RP2D) is defined, 12 additional patients will be accrued to the expansion phase. Following the completion of screening/baseline procedures, eligible participants will undergo bone marrow aspiration in order to obtain MSCs. The MSC investigational product will be injected into one or both submandibular glands under local anesthesia at the interventional visit.

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Actual Study Start Date : 2024-10
Estimated Primary Completion Date : 2028-11
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 (called "medical" xerostomia in this protocol, for example, resulting from Sjögren's Disease or Graft versus Host Disease)
  • * ≥ 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
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

Location Details

NCT06392711

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How to Participate

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Locations

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53705