Radiation-Induced XerostomiaPhase 1NCT07431645
Pilot Study of Radiation-Induced Xerostomia Treatment With Allogeneic Mesenchymal Stromal Stem Cells
A Phase 1 study testing Allogeneic Mesenchymal Stromal Cells (MSC) in people with Radiation-Induced Xerostomia and Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This pilot interventional study evaluates the safety and preliminary efficacy of treatment with allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue in patients with radiation-induced xerostomia after radiotherapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-Induced Xerostomia, Head and Neck Cancer
- What is being tested?
- Allogeneic Mesenchymal Stromal Cells (MSC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Apr 2023to 10 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- History of radiotherapy for head and neck cancer
- Presence of radiation-induced xerostomia
- Completed oncological treatment
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Active malignant disease requiring ongoing oncological treatment
- Acute infection or inflammation in the oral cavity or salivary glands
- Severe systemic disease or condition that could influence study results
- Contraindication to the planned intervention (MSC administration)
- Pregnancy or breastfeeding
- Any condition that, in the investigator's opinion, would interfere with participation or evaluation of outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Treating Radiation-Induced Xerostomia Using Allogeneic Mesenchymal Stromal Stem Cells
This pilot interventional study evaluates the safety and preliminary efficacy of treatment with allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue in patients with radiation-induced xerostomia after radiotherapy for head and neck cancer. Xerostomia is a frequent late adverse effect of radiotherapy and can significantly impair oral function and quality of life.
Participants receive a single administration of allogeneic MSCs as the study intervention and are followed for clinical outcomes. The study evaluates safety, salivary gland function, subjective xerostomia symptoms, and imaging-based changes in salivary gland tissue.
The results of this pilot study may support the development of regenerative treatment strategies for radiation-induced salivary gland damage.
Read the detailed description
This is a prospective pilot interventional clinical study designed to assess the safety and preliminary efficacy of treatment of radiation-induced xerostomia using allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue. Radiation-induced xerostomia is a common late complication in patients treated with radiotherapy for head and neck cancer and is associated with reduced salivary flow, impaired oral health, swallowing difficulties, and decreased quality of life.
Allogeneic MSCs are characterized by strong immunomodulatory properties and regenerative potential. In this study, MSCs obtained from umbilical cord tissue are administered as a therapeutic intervention to evaluate their potential to improve salivary gland function and reduce symptoms of xerostomia.
The primary objective of the study is to assess the safety of MSC administration, with follow-up monitoring for adverse events during a four-month period after the intervention.
Secondary objectives include evaluation of preliminary efficacy of MSC therapy by assessing:
subjective xerostomia symptoms and patient-reported outcomes,
salivary flow and salivary quality parameters,
radiological, scintigraphic, and morphological changes of salivary gland tissue following treatment.
Participants undergo structured clinical evaluations and follow-up assessments according to the study protocol. The study aims to provide early evidence on feasibility and potential clinical benefit of MSC-based therapy for the treatment of radiation-induced xerostomia.
- Conditions
- Radiation-Induced Xerostomia, Head and Neck Cancer
- Being tested
- Allogeneic Mesenchymal Stromal Cells (MSC)
- Keywords
- Xerostomia, Radiotherapy, Head and Neck Cancer
- 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.
Allogeneic Mesenchymal Stromal Cells (MSC)Biological
Also called Umbilical Cord-Derived MSC, Allogeneic UC-MSC
Allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue are administered to participants with radiation-induced xerostomia following radiotherapy for head and neck cancer. The intervention is performed according to the study protocol to evaluate safety and preliminary efficacy. Participants are monitored for adverse events and changes in salivary gland function, saliva quality, imaging findings, and xerostomia-related symptoms during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic MSC Treatment for Radiation-Induced Xerostomia | Experimental | Participants with radiation-induced xerostomia following radiotherapy for head and neck cancer receive a single administration of allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue. The intervention is performed according to the study protocol, and participants are prospectively followed to assess safety and preliminary efficacy, including salivary gland function, salivary quality, imaging findings, and patient-reported outcomes related to xerostomia. Receives: Biological: Allogeneic Mesenchymal Stromal Cells (MSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia
Safety is assessed by the incidence, type, and severity of adverse events and serious adverse events following administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSC) in participants with radiation-induced xerostomia.
Measured: From intervention through 4 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Apr 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced XerostomiaStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- Participants with radiation-induced xerostomia receive allogeneic umbilical cord-derived mesenchymal stromal cells (MSC). Safety and preliminary efficacy outcomes are assessed during follow-up after the intervention.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431645
- Sponsor's protocol ID
- OI-XEROSTOMIA-MSC-2023
- Other IDs
- ERID-KSOPR-0026/2023
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Treating Radiation-Induced Xerostomia Using Allogeneic Mesenchymal Stromal Stem Cells
- ClinicalTrials.gov ID
- NCT07431645
- Acronym / sponsor ID
- OI-XEROSTOMIA-MSC-2023
- Conditions
- Radiation-Induced Xerostomia, Head and Neck Cancer
- Keywords
- Xerostomia, Radiotherapy, Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 24 Feb 2026 (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.
This pilot interventional study evaluates the safety and preliminary efficacy of treatment with allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue in patients with radiation-induced xerostomia after radiotherapy for head and neck cancer. Xerostomia is a frequent late adverse effect of radiotherapy and can significantly impair oral function and quality of life.
Participants receive a single administration of allogeneic MSCs as the study intervention and are followed for clinical outcomes. The study evaluates safety, salivary gland function, subjective xerostomia symptoms, and imaging-based changes in salivary gland tissue.
The results of this pilot study may support the development of regenerative treatment strategies for radiation-induced salivary gland damage.
Detailed description
This is a prospective pilot interventional clinical study designed to assess the safety and preliminary efficacy of treatment of radiation-induced xerostomia using allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue. Radiation-induced xerostomia is a common late complication in patients treated with radiotherapy for head and neck cancer and is associated with reduced salivary flow, impaired oral health, swallowing difficulties, and decreased quality of life.
Allogeneic MSCs are characterized by strong immunomodulatory properties and regenerative potential. In this study, MSCs obtained from umbilical cord tissue are administered as a therapeutic intervention to evaluate their potential to improve salivary gland function and reduce symptoms of xerostomia.
The primary objective of the study is to assess the safety of MSC administration, with follow-up monitoring for adverse events during a four-month period after the intervention.
Secondary objectives include evaluation of preliminary efficacy of MSC therapy by assessing:
subjective xerostomia symptoms and patient-reported outcomes,
salivary flow and salivary quality parameters,
radiological, scintigraphic, and morphological changes of salivary gland tissue following treatment.
Participants undergo structured clinical evaluations and follow-up assessments according to the study protocol. The study aims to provide early evidence on feasibility and potential clinical benefit of MSC-based therapy for the treatment of radiation-induced xerostomia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants with radiation-induced xerostomia receive allogeneic umbilical cord-derived mesenchymal stromal cells (MSC). Safety and preliminary efficacy outcomes are assessed during follow-up after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Allogeneic MSC Treatment for Radiation-Induced Xerostomia | Experimental | Biological: Allogeneic Mesenchymal Stromal Cells (MSC)Participants with radiation-induced xerostomia following radiotherapy for head and neck cancer receive a single administration of allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue. The intervention is performed according to the study protocol, and participants are prospectively followed to assess safety and preliminary efficacy, including salivary gland function, salivary quality, imaging findings, and patient-reported outcomes related to xerostomia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- History of radiotherapy for head and neck cancer
- Presence of radiation-induced xerostomia
- Completed oncological treatment
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (6 listed)
- Active malignant disease requiring ongoing oncological treatment
- Acute infection or inflammation in the oral cavity or salivary glands
- Severe systemic disease or condition that could influence study results
- Contraindication to the planned intervention (MSC administration)
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Allogeneic Mesenchymal Stromal Cells (MSC)Also: Umbilical Cord-Derived MSC, Allogeneic UC-MSCAllogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue are administered to participants with radiation-induced xerostomia following radiotherapy for head and neck cancer. The intervention is performed according to the study protocol to evaluate safety and preliminary efficacy. Participants are monitored for adverse events and changes in salivary gland function, saliva quality, imaging findings, and xerostomia-related symptoms during follow-up. | Biological | Allogeneic MSC Treatment for Radiation-Induced Xerostomia |
Primary outcome
Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia
Time frame: From intervention through 4 months after the intervention
Safety is assessed by the incidence, type, and severity of adverse events and serious adverse events following administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSC) in participants with radiation-induced xerostomia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Radiation-Induced Xerostomia
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RecruitingPhase 2
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
Head and Neck Cancer
Active, not recruitingPhase 3
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
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RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Active, not recruitingPhase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Allogeneic Mesenchymal Stromal Cells (MSC) in people with Radiation-Induced Xerostomia and Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 Mar 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia (time frame: From intervention through 4 months after the intervention). 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 3 Mar 2026.