Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04489732 · ClinicalTrials.gov registry record · Phase 1
MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer
A Phase 1 study of Xerostomia Following Radiotherapy, sponsored by University of Wisconsin, Madison.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04489732: Active Phase 1 study of Xerostomia Following Radiotherapy, sponsored by University of Wisconsin, Madison.
NCT04489732 is a Phase 1 study of Xerostomia Following Radiotherapy that is active but no longer recruiting, run by University of Wisconsin, Madison. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04489732, a Phase 1 study of Xerostomia Following Radiotherapy, is active but no longer recruiting, sponsored by University of Wisconsin, Madison.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single center pilot study designed to determine the safety and tolerability of autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12 participants will be enrolled and can expect to be on study for up to 2 years.
Primary Outcome
Dose limiting toxicity is defined as: submandibular pain \> 5 on a pain scale of 0-10 at 1-month after MSC injection OR any serious AE OR any of the selected toxicities listed per protocol within one-month post-injection.
Conditions Studied
Interventions
- BIOLOGICAL Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells
Study Locations (1)
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What the registry record for NCT04489732 still lists
NCT04489732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Xerostomia Following Radiotherapy appearing as the primary indexed condition, and to 1 intervention - of which Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells is the first listed.
NCT04489732 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04489732 about?
NCT04489732 is a clinical study titled "MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer". This is a single center pilot study designed to determine the safety and tolerability of autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12 participants will be enro...
What is the current status of trial NCT04489732?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-02-18. Estimated completion is 2026-05.
What conditions does trial NCT04489732 study?
This clinical trial studies the following conditions: Xerostomia Following Radiotherapy.
What interventions are being tested in trial NCT04489732?
The interventions under investigation include: Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04489732?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04489732 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
How this trial's enrollment target compares
Where NCT04489732's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI