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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06392711
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesenchymal Stromal Cells (MSC) Dose Level 0 — BIOLOGICAL
    10 (8-12) x 10\^6 MSCs
  • Mesenchymal Stromal Cells (MSC) Dose Level 1 — BIOLOGICAL
    20 (16-24) x 10\^6

Study Details

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

Key Dates

Start date
Oct 4, 2024
Status verified
Oct 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Proportion of participants experiencing DLT of submandibular pain [ Time Frame: 1 month post-injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Cancer Connect
[email protected]
800-622-8922

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By research site
University of Wisconsin· Madison, WI

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