Clinical Trial Finder

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06392711
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Sara McCoy, MD, PhD
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Xerostomia, Graft-versus-host-disease, Sjogren's Disease
Additional Details

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.

Arms & Interventions

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

Biological: - Mesenchymal Stromal Cells (MSC) Dose Level 0

10 (8-12) x 10^6 MSCs

Biological: - Mesenchymal Stromal Cells (MSC) Dose Level 1

20 (16-24) x 10^6

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Wisconsin, Madison, Wisconsin

Status

Address

University of Wisconsin

Madison, Wisconsin, 53705

Site Contact

Cancer Connect

[email protected]

800-622-8922

Powered By