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NCT06392711 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
A Phase 1 study of Graft-Versus-Host Disease and Xerostomia, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06392711: Recruiting Phase 1 study of Graft-Versus-Host Disease and Xerostomia, sponsored by University of Wisconsin, Madison.
NCT06392711 is a Phase 1 study of Graft-Versus-Host Disease and Xerostomia that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 36 participants, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06392711, a Phase 1 study of Graft-Versus-Host Disease and Xerostomia, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Recommended phase II dose (RP2D) will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of submandibular pain \> 5 on a standard 10-point pain scale of 0-10 at 1-month after MSC injection
Conditions Studied
Interventions
- BIOLOGICAL Mesenchymal Stromal Cells (MSC) Dose Level 0
- BIOLOGICAL Mesenchymal Stromal Cells (MSC) Dose Level 1
Study Locations (1)
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-10-04 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What NCT06392711 shows while recruiting
NCT06392711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (56% lower).
The record links to 3 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 2 interventions - of which Mesenchymal Stromal Cells (MSC) Dose Level 0 is the first listed.
NCT06392711 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06392711 about?
NCT06392711 is a clinical study titled "Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia". 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...
What is the current status of trial NCT06392711?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-10-04. Estimated completion is 2028-11.
What conditions does trial NCT06392711 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease, Xerostomia, Sjogrens Disease.
What interventions are being tested in trial NCT06392711?
The interventions under investigation include: Mesenchymal Stromal Cells (MSC) Dose Level 0 (BIOLOGICAL), Mesenchymal Stromal Cells (MSC) Dose Level 1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06392711?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06392711 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06392711's enrollment target sits among peer trials
36 23rd of 38 higher than 16 of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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