Head and Neck CancerPhase 1NCT05820711
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
A Phase 1 study testing MSC in people with Head and Neck Cancer and Xerostomia, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Cancer, Xerostomia
- What is being tested?
- MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Salivary gland disease (i.e., sialolithiasis)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
Official title: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
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.
- Conditions
- Head and Neck Cancer, Xerostomia
- Being tested
- MSC
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCDrug
Injection of MSCs into submandibular glands at pre-specified dose level:
- Dose -1: 5 (4 - 6) x10^6 MSCs (to be used only if Dose level 1 is not tolerated) per gland (0.5 ml)
- Dose 0: 10 (8 - 12) x10^6 MSCs per gland (1 ml)
- Dose 1: 20 (16 - 24) x10^6 MSCs per gland (2 ml)
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cell (MSC) injection | Experimental | Not described Receives: Drug: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Measured: Up to 1 month post-injection
Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale
Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
Measured: 1 month post-injection
Safety and Tolerability: Number of Serious Adverse Events
Incidence of any serious adverse event
Measured: Up to 1 month post-injection
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
Incidence of pre-specified adverse events
Measured: Up to 1 month post-injection
Secondary outcomes (5)
Change in Quality of Life
Efficacy of MSC assessed through University of Michigan Xerostomia Related Quality of Life (XeQOL) scale, which is a 15-item assessment scale with 4 domains. The score is the average of all responses of all domains and can range from 0 to 4, where higher scores indicate increased xerostomia burden.
Measured: Baseline to 24 months post-injection
Change in Quality of Life
Efficacy of MSC assessed through the MD Anderson Dysphagia Index (MDADI), which is a 20-item questionnaire designed for evaluating the impact of dysphagia (swallowing ability). Scores range from 20 (extremely low functioning) to 100 (high functioning).
Measured: Baseline to 24 months post-injection
Change in Quality of Life
Efficacy of MSC assessed through VAS xerostomia questionnaire, which is an 8-item questionnaire that measures the perception of dry mouth. Scores range from 0-10, with 0 being low dryness and 10 being high dryness.
Measured: Baseline to 24 months post-injection
Change in salivary production
Saliva production will be measured by having participants chew inert gum base to the pace of a metronome (70 beats per minute) while expectorating saliva (without swallowing) into the saliva collection aid for 5 minutes total40. Cryovials will be weighed before and after collection and the difference in weight (g) will represent the amount of saliva produced in 5 minutes for each condition.
Measured: Baseline to 24 months post-injection
Shear wave velocity with acoustic radiation force impulse
Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound
Measured: 3, 6, and 12 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start17 Jul 2023
- Primary completion9 Dec 2025
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Grace Blitzer, MD, Principal investigator, University of Wisconsin, MadisonJacques Galipeau, MD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820711
- Sponsor's protocol ID
- 2023-0194
- Other IDs
- UW21144, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, Protocol Version 7/14/2026, 4UH3DE030431-02, A533300
- Status last verified
- Feb 2026
- First submitted
- 6 Apr 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05820711
- Acronym / sponsor ID
- 2023-0194
- Conditions
- Head and Neck Cancer, Xerostomia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem Cell (MSC) injection | Experimental | Drug: MSC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Salivary gland disease (i.e., sialolithiasis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCInjection of MSCs into submandibular glands at pre-specified dose level: * Dose -1: 5 (4 - 6) x10^6 MSCs (to be used only if Dose level 1 is not tolerated) per gland (0.5 ml) * Dose 0: 10 (8 - 12) x10^6 MSCs per gland (1 ml) * Dose 1: 20 (16 - 24) x10^6 MSCs per gland (2 ml) | Drug | Mesenchymal Stem Cell (MSC) injection |
Primary outcome
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
Time frame: Up to 1 month post-injection
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale
Time frame: 1 month post-injection
Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
Safety and Tolerability: Number of Serious Adverse Events
Time frame: Up to 1 month post-injection
Incidence of any serious adverse event
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
Time frame: Up to 1 month post-injection
Incidence of pre-specified adverse events
5 secondary outcomes
Change in Quality of Life
Time frame: Baseline to 24 months post-injection
Change in Quality of Life
Time frame: Baseline to 24 months post-injection
Change in Quality of Life
Time frame: Baseline to 24 months post-injection
Change in salivary production
Time frame: Baseline to 24 months post-injection
Shear wave velocity with acoustic radiation force impulse
Time frame: 3, 6, and 12 months post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Blitzer, MD principal investigator
University of Wisconsin, Madison
Jacques Galipeau, MD study director
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSC in people with Head and Neck Cancer and Xerostomia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D) (time frame: Up to 1 month post-injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.