RECRUITING

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

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Conditions

XerostomiaGraft-versus-host-diseaseSjogren's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

Quick Facts

Study Start:2024-10-04
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06392711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Xerostomia, defined as an unstimulated salivary flow of less than or equal to 0.5 mL in 5 minutes
  2. * Xerostomia not resulting from radiotherapy (called "medical" xerostomia in this protocol, for example, resulting from Sjögren's Disease or Graft versus Host Disease)
  3. * ≥ 18 years of age, ≤ 90 years of age
  4. * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
  5. * Willing and able to give informed consent
  6. * Radiographically confirmed bilateral submandibular glands
  7. * If female of childbearing potential, negative pregnancy test
  8. * Males and females of childbearing potential willing to use acceptable contraception
  9. * Laboratory Values (within 42 calendar days of enrollment):
  10. * Hgb ≥ 9 g/dL (5.58 mmol/L)
  11. * Platelets ≥ 100,000/µL
  12. * ANC ≥ 1000/µL
  13. * Lymphocytes ≥ 800/µL
  14. * PT/INR and PTT within normal limits based on age/sex
  1. * Patients with one submandibular gland
  2. * Sialolithiasis
  3. * Poorly-controlled diabetes mellitus (HBA1c ≥ 7%)
  4. * Patients who initiated any diuretic therapy before developing dry mouth symptoms or ESRD
  5. * Untreated oral candidiasis based on physical exam at enrollment
  6. * 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)
  7. * 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
  8. * Transfusion dependency
  9. * Life expectancy ≤ 6 months as determined by the investigator
  10. * Use of investigational drugs, biologics, or devices within 30 calendar days prior to enrollment
  11. * Pregnant or lactating women or those who plan to become pregnant during the study
  12. * Not suitable for study participation due to other reasons at discretion of investigators.
  13. * Enrollment in another clinical study possibly interfering with the endpoints of this study

Contacts and Locations

Study Contact

Cancer Connect
CONTACT
800-622-8922
clinicaltrials@cancer.wisc.edu

Principal Investigator

Sara McCoy, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Jacques Galipeau, MD
STUDY_DIRECTOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Sara McCoy, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison
  • Jacques Galipeau, MD, STUDY_DIRECTOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-04
Study Completion Date2028-11

Study Record Updates

Study Start Date2024-10-04
Study Completion Date2028-11

Terms related to this study

Additional Relevant MeSH Terms

  • Xerostomia
  • Graft-versus-host-disease
  • Sjogren's Disease