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NCT04007081 · ClinicalTrials.gov registry record · NA
Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia
A NA study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04007081: Completed NA study, sponsored by University of Wisconsin, Madison.
NCT04007081 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04007081, a NA study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Xerostomia, or dry mouth, is a common side effect of head neck radiation. Current treatment options for radiation-induced xerostomia are generally supportive in nature. Most of these supportive interventions do not reverse xerostomia and are palliative in intent. The investigators propose that autotransplantation of marrow-derived mesenchymal stromal cells (MSCs) in salivary glands post-RT or post-chemoradiation therapy (CRT) may provide an innovative remedy to treat xerostomia and restore quality of life. Participants can expect to be on study for up to 6 months.
Primary Outcome
The feasibility of in vitro expansion of MSCs derived from marrow aspirates collected from participants will be determined by if they can be culture expanded for up to two weeks to generate \>50 million MSCs per donor. Feasibility will reported as the number of participants whose marrow-derived MSCs can be expanded in vitro to \> 50 million cells within two weeks.
Interventions
- PROCEDURE Bone Marrow Aspiration
- DIAGNOSTIC_TEST Ultrasound Imaging of Salivary Glands
- OTHER Salivary Assay
- OTHER Quality of Life Instruments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2021-03-10 |
| Phase | NA |
What the finished NCT04007081 record still lists
NCT04007081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Bone Marrow Aspiration is the first listed.
NCT04007081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04007081 about?
NCT04007081 is a clinical study titled "Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia". Xerostomia, or dry mouth, is a common side effect of head neck radiation. Current treatment options for radiation-induced xerostomia are generally supportive in nature. Most of these supportive interventions do not reverse xerostomia and are palliative in intent. The investigators propose that auto...
What is the current status of trial NCT04007081?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-10-18. Estimated completion is 2021-03-10.
What interventions are being tested in trial NCT04007081?
The interventions under investigation include: Bone Marrow Aspiration (PROCEDURE), Ultrasound Imaging of Salivary Glands (DIAGNOSTIC_TEST), Salivary Assay (OTHER), Quality of Life Instruments (OTHER).
Who is sponsoring clinical trial NCT04007081?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04007081's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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