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NCT05820711 · ClinicalTrials.gov registry record · Phase 1
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
A Phase 1 study of Head and Neck Cancer and Xerostomia, sponsored by University of Wisconsin, Madison.
- Active
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT05820711: Active Phase 1 study of Head and Neck Cancer and Xerostomia, sponsored by University of Wisconsin, Madison.
NCT05820711 is a Phase 1 study of Head and Neck Cancer and Xerostomia that is active but no longer recruiting, run by University of Wisconsin, Madison. The registered enrollment target is 23 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05820711, a Phase 1 study of Head and Neck Cancer and Xerostomia, is active but no longer recruiting, sponsored by University of Wisconsin, Madison.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands. Participants will have head and neck cancer that was treated with radiation therapy, and in this study will: * Undergo a collection of bone marrow using a needle; * Donate saliva; * Undergo a salivary gland ultrasound; and, * Complete questionnaires that ask about dry mouth Participants can expect to be in this study for up to 30 months. There is no expanded access program available per this protocol.
Primary Outcome
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Conditions Studied
Interventions
- DRUG MSC
Study Locations (1)
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-07-17 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
What the registry record for NCT05820711 still lists
NCT05820711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which MSC is the first listed.
NCT05820711 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05820711 about?
NCT05820711 is a clinical study titled "Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy". The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands. Participants will have head and neck cancer that was treated with radiation therapy, an...
What is the current status of trial NCT05820711?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2023-07-17. Estimated completion is 2028-01.
What conditions does trial NCT05820711 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Xerostomia.
What interventions are being tested in trial NCT05820711?
The interventions under investigation include: MSC (DRUG).
Who is sponsoring clinical trial NCT05820711?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05820711 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
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05820711's enrollment target sits among peer trials
23 210th of 250 higher than 38 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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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