NCT05820711Active, not recruitingPhase 1
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 6 Apr 2023
- Start date
- 17 Jul 2023
- Primary completion date
- 9 Dec 2025
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Head and neck cancer
- NCT number
- NCT05820711
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 23
- From 17 Jul 2023 to the primary completion date, 9 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Salivary gland disease (i.e., sialolithiasis)
Who the study is looking for
- History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED)
- Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation)
- ≥ 18 years of age, ≤ 90 years of age.
- Patients ≥ 2 years from completion of radiation therapy for HNC
- Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
- Willing and able to give informed consent
- Radiographically confirmed submandibular gland(s)
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.