Xerostomia Following RadiotherapyPhase 1NCT06012604
Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells
A Phase 1 study testing allogeneic mesenchymal stromal stem cells in people with Xerostomia Following Radiotherapy, run by Institute of Oncology Ljubljana at 4 sites in Slovenia.
Trial summary
The goal of this clinical trial is to learn about toxicity of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) treatment in head and neck cancer patients with for post-radiation xerostomia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerostomia Following Radiotherapy
- What is being tested?
- allogeneic mesenchymal stromal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesSlovenia
- Study dates
- Sep 2023to Aug 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- squamous cell carcinoma of the oropharynx, Union for International Cancer Control TNM Classification of Malignant Tumors )8th ed.) clinical stage T1-2N+ or cT3-4cN0-3 M0, treated with curative intent radiotherapy (tumor dose 66-70 Gy, bilateral neck irradiation) with or without concurrent chemotherapy
- 2 years or more post-treatment without signs of locoregional recurrence or systemic metastasis
- non-smoker or former smoker (quit smoking ≥2 years ago)
- mean radiation dose >26 Gy to each of the parotid glands and >35 Gy to each of the submandibular glands
- xerostomia of grade 2 or 3, assessed according to the CTCAE v5.0 scale
- Clinically reduced salivary flow and hyposalivation (unstimulated whole saliva flow rate 0.05-0.20 ml/min)
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- age between 18-75 years
- both sexes
- signed "Informed Consent Form" for participation in the study
Who cannot join
- newly diagnosed malignancy anywhere in the body within the past two years
- active smoker
- use of medications with potential to cause dry mouth (e.g., tricyclic antidepressants, antipsychotics, decongestants, bronchodilators, antihypertensives like beta-blockers and diuretics, antihistamines, hypnotic sedatives, opioids, and muscle relaxants)
- other salivary gland diseases (e.g., Sjögren's syndrome, scleroderma, sialolithiasis, etc.)
- patients on anticoagulant therapy that cannot be discontinued during the intervention
- pregnancy or planned pregnancy within the next two years
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- breastfeeding
- active, uncontrolled infection or other medical (including psychiatric) conditions that, in the researchers' opinion, do not allow for the safe administration of the planned therapy and performance of the follow-up procedures
- known substance abuse or alcoholism
Trial locations and contacts
4 sites in 1 country.
Slovenia4 sites
Blood Transfusion Center of Slovenia
Ljubljana, SI-1000
Urban Švajger, Prof., +386 1 5438 391, urban.svajger@ztm.si
Urban Švajger, Prof.
Institute of Oncology Ljubljana
Ljubljana, SI-1000
University Clinical Center Ljubljana
Ljubljana, SI-1000
Luka Ležaić, MD, +386 1 522 34 49, luka.lezaic@kclj.si
Luka Ležaić, MD
University of Ljubljana
Ljubljana, SI-1000
About this study
Official title: Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells: a Pilot Study
The goal of this clinical trial is to learn about toxicity of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) treatment in head and neck cancer patients with for post-radiation xerostomia. The main question it aims to answer is the toxicity of intervention and the secondary objective is to assess preliminary efficacy. Participants will receive MSC in both parotid and submandibular glands: the toxicity of the intervention will be assessed using CTCAE v5.0 and its effect will be evaluated through measuring salivary flow and composition, radiologically (ultrasonography, magnetic resonance imaging), with scintigraphy and questionnaires. In the control group, salivary gland function (salivary flow and saliva composition) will be assessed for comparison with the intervention group.
Read the detailed description
The aim of the study is to assess the safety and preliminary efficacy of treating xerostomia with allogeneic mesenchymal stromal stem cells (MSC) derived from umbilical cord tissue. This is a non-randomized, single-center, non-blinded Phase I study. There will be 10 patients in the intervention group and 10 healthy volunteers in the control group. In the intervention group, patients who were successfully treated with (chemo)radiotherapy for oropharyngeal squamous cell carcinoma two or more years ago and have xerostomia of grade 2 or 3 according to CTCAE v.5.0 will receive MSC injections under ultrasound guidance into both parotid and submandibular glands (1 ml syringe with 50×106 MSC and 0.5 ml syringe with 25×106 MSC). Before the application, measurements of unstimulated and stimulated saliva flow, saliva composition, and blood parameters (complete blood count, biochemical tests, prothrombin time, international normalized ratio) will be performed. Magnetic resonance imaging of the glands (to assess changes in volume, signal, and diffusivity), ultrasound elastography (to assess gland consistency), salivary gland scintigraphy with pertechnetate ([99mTc]TcO4-, to evaluate radioisotope uptake in functioning parenchyma and excretory fraction of each gland) and scintigraphy with hexamethylpropyleneamine oxime ([99mTc]Tc-HMPAO)-labeled MSC (to assess distribution, retention, and migration of MSC from the site of application) will also be conducted, along with a biopsy from one of the four glands (to evaluate morphological changes in glandular tissue). Patients will complete two xerostomia questionnaires and a quality of life questionnaire European Organization for Research and Treatment of Cancer Quality of Life H\&N35. On the 1st and 5th day after the intervention (day 0), patients will be examined, and toxicity will be assessed according to CTCAE v5.0. The effect of the intervention will be evaluated at 4 weeks and 4 months, repeating the tests performed before the intervention, with the exception of the biopsy and scintigraphy, which will be repeated only 4 months after the intervention (from the same gland as the first time). In the control group, healthy individuals will submit saliva samples to determine unstimulated and stimulated saliva flow and saliva composition (for comparison with the intervention group).
- Conditions
- Xerostomia Following Radiotherapy
- Being tested
- allogeneic mesenchymal stromal stem cells
- Keywords
- post-radiation xerostomia, allogenic mesenchyma stromal stem cells, toxicity, effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic mesenchymal stromal stem cellsBiological
mesenchymal stromal stem cells injection under ultrasound guidance into parotid and submandibular glands
| Study group | Role | What they receive |
|---|---|---|
| allogeneic mesenchymal stromal stem cells | Experimental | Application of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) under ultrasound guidance into both parotid and submandibular glands. Receives: Biological: allogeneic mesenchymal stromal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of patients with serious adverse events
Registration of number of patients with serious adverse events in a 4 months follow-up period
Measured: 4 months
Secondary outcomes (8)
Efficacy: Change in unstimulated and stimulated whole salivary flow rate
Flow rates assessed by sialometry
Measured: 4 months
Efficacy: Change in saliva composition
Change in saliva composition
Measured: 4 months
Efficacy: Change in subjective assessment of xerostomia
Change in subjective assessment of xerostomia evaluated by Visual Analog Scale (VAS) questionnaire
Measured: 4 months
Efficacy: Change in quality of life
Change in quality of life evaluated by QLQ-H\&N-35 questionnaire
Measured: at baseline and 4 weeks and 4 months after intervention
Efficacy: performance of MSCs application
Assessed by salivary gland scintigraphy with [99mTc]Tc-HMPAO labeled MSCs
Measured: 4 months
Efficacy: Salivary gland function
Assessed by salivary gland scintigraphy with pertechnetate ([99mTc]TcO4-)
Measured: 4 months
Efficacy: salivary gland appearance
Assessed by magnetic resonance imaging and ultrasonography
Measured: 4 months
Efficacy: salivary gland structure
Assessed by histopathological examination of salivary gland tissue sample
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia Following RadiotherapyStudies 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
- intervention group control group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Blood Transfusion Centre of Slovenia, University Medical Centre Ljubljana, University of Ljubljana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012604
- Sponsor's protocol ID
- ERIDNPVO-0038/2023
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2023
- Last updated
- 25 Aug 2023
- 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 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells: a Pilot Study
- ClinicalTrials.gov ID
- NCT06012604
- Acronym / sponsor ID
- ERIDNPVO-0038/2023
- Conditions
- Xerostomia Following Radiotherapy
- Keywords
- post-radiation xerostomia, allogenic mesenchyma stromal stem cells, toxicity, effectiveness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Collaborators
- Blood Transfusion Centre of Slovenia, University Medical Centre Ljubljana, University of Ljubljana
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 25 Aug 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 trial is to learn about toxicity of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) treatment in head and neck cancer patients with for post-radiation xerostomia. The main question it aims to answer is the toxicity of intervention and the secondary objective is to assess preliminary efficacy. Participants will receive MSC in both parotid and submandibular glands: the toxicity of the intervention will be assessed using CTCAE v5.0 and its effect will be evaluated through measuring salivary flow and composition, radiologically (ultrasonography, magnetic resonance imaging), with scintigraphy and questionnaires. In the control group, salivary gland function (salivary flow and saliva composition) will be assessed for comparison with the intervention group.
Detailed description
The aim of the study is to assess the safety and preliminary efficacy of treating xerostomia with allogeneic mesenchymal stromal stem cells (MSC) derived from umbilical cord tissue. This is a non-randomized, single-center, non-blinded Phase I study. There will be 10 patients in the intervention group and 10 healthy volunteers in the control group. In the intervention group, patients who were successfully treated with (chemo)radiotherapy for oropharyngeal squamous cell carcinoma two or more years ago and have xerostomia of grade 2 or 3 according to CTCAE v.5.0 will receive MSC injections under ultrasound guidance into both parotid and submandibular glands (1 ml syringe with 50×106 MSC and 0.5 ml syringe with 25×106 MSC). Before the application, measurements of unstimulated and stimulated saliva flow, saliva composition, and blood parameters (complete blood count, biochemical tests, prothrombin time, international normalized ratio) will be performed. Magnetic resonance imaging of the glands (to assess changes in volume, signal, and diffusivity), ultrasound elastography (to assess gland consistency), salivary gland scintigraphy with pertechnetate ([99mTc]TcO4-, to evaluate radioisotope uptake in functioning parenchyma and excretory fraction of each gland) and scintigraphy with hexamethylpropyleneamine oxime ([99mTc]Tc-HMPAO)-labeled MSC (to assess distribution, retention, and migration of MSC from the site of application) will also be conducted, along with a biopsy from one of the four glands (to evaluate morphological changes in glandular tissue). Patients will complete two xerostomia questionnaires and a quality of life questionnaire European Organization for Research and Treatment of Cancer Quality of Life H\&N35. On the 1st and 5th day after the intervention (day 0), patients will be examined, and toxicity will be assessed according to CTCAE v5.0. The effect of the intervention will be evaluated at 4 weeks and 4 months, repeating the tests performed before the intervention, with the exception of the biopsy and scintigraphy, which will be repeated only 4 months after the intervention (from the same gland as the first time). In the control group, healthy individuals will submit saliva samples to determine unstimulated and stimulated saliva flow and saliva composition (for comparison with the intervention group).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intervention group control group
| Arm | Type | Receives |
|---|---|---|
| allogeneic mesenchymal stromal stem cells | Experimental | Biological: allogeneic mesenchymal stromal stem cellsApplication of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) under ultrasound guidance into both parotid and submandibular glands. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- squamous cell carcinoma of the oropharynx, Union for International Cancer Control TNM Classification of Malignant Tumors )8th ed.) clinical stage T1-2N+ or cT3-4cN0-3 M0, treated with curative intent radiotherapy (tumor dose 66-70 Gy, bilateral neck irradiation) with or without concurrent chemotherapy
- 2 years or more post-treatment without signs of locoregional recurrence or systemic metastasis
- non-smoker or former smoker (quit smoking ≥2 years ago)
- mean radiation dose >26 Gy to each of the parotid glands and >35 Gy to each of the submandibular glands
- xerostomia of grade 2 or 3, assessed according to the CTCAE v5.0 scale
Key exclusion criteria (9 listed)
- newly diagnosed malignancy anywhere in the body within the past two years
- active smoker
- use of medications with potential to cause dry mouth (e.g., tricyclic antidepressants, antipsychotics, decongestants, bronchodilators, antihypertensives like beta-blockers and diuretics, antihistamines, hypnotic sedatives, opioids, and muscle relaxants)
- other salivary gland diseases (e.g., Sjögren's syndrome, scleroderma, sialolithiasis, etc.)
- patients on anticoagulant therapy that cannot be discontinued during the intervention
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 stem cellsmesenchymal stromal stem cells injection under ultrasound guidance into parotid and submandibular glands | Biological | allogeneic mesenchymal stromal stem cells |
Primary outcome
Safety: Number of patients with serious adverse events
Time frame: 4 months
Registration of number of patients with serious adverse events in a 4 months follow-up period
8 secondary outcomes
Efficacy: Change in unstimulated and stimulated whole salivary flow rate
Time frame: 4 months
Efficacy: Change in saliva composition
Time frame: 4 months
Efficacy: Change in subjective assessment of xerostomia
Time frame: 4 months
Efficacy: Change in quality of life
Time frame: at baseline and 4 weeks and 4 months after intervention
Efficacy: performance of MSCs application
Time frame: 4 months
Efficacy: Salivary gland function
Time frame: 4 months
Efficacy: salivary gland appearance
Time frame: 4 months
Efficacy: salivary gland structure
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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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.
4 sites 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 stem cells in people with Xerostomia Following Radiotherapy, run by Institute of Oncology Ljubljana at 4 sites 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Primož Strojan, Prof. (+38615879290, pstrojan@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of patients with serious adverse events (time frame: 4 months). 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 25 Aug 2023.