- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012604
Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells
August 22, 2023 updated by: Institute of Oncology Ljubljana
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Primož Strojan, Prof.
- Phone Number: +38615879290
- Email: pstrojan@onko-i.si
Study Contact Backup
- Name: Violeta Kaluža
- Phone Number: +38615879122
- Email: vkaluza@onko-i.si
Study Locations
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-
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Ljubljana, Slovenia, SI-1000
- Institute of Oncology Ljubljana
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Ljubljana, Slovenia, SI-1000
- Blood Transfusion Center of Slovenia
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Contact:
- Urban Švajger, Prof.
- Phone Number: +386 1 5438 391
- Email: urban.svajger@ztm.si
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Principal Investigator:
- Urban Švajger, Prof.
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Sub-Investigator:
- Nataša Tešić, Dr.
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Sub-Investigator:
- Katarina Hartman, Dr.
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Ljubljana, Slovenia, SI-1000
- University Clinical Center Ljubljana
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Contact:
- Luka Ležaić, MD
- Phone Number: +386 1 522 34 49
- Email: luka.lezaic@kclj.si
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Sub-Investigator:
- Luka Ležaić, MD
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Sub-Investigator:
- Alkaž Sočan, PhD.
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Ljubljana, Slovenia, SI-1000
- University of Ljubljana
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
- age between 18-75 years
- both sexes
- signed "Informed Consent Form" for participation in the study
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: allogeneic mesenchymal stromal stem cells
Application of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) under ultrasound guidance into both parotid and submandibular glands.
|
mesenchymal stromal stem cells injection under ultrasound guidance into parotid and submandibular glands
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Change in unstimulated and stimulated whole salivary flow rate
Time Frame: 4 months
|
Flow rates assessed by sialometry
|
4 months
|
Efficacy: Change in saliva composition
Time Frame: 4 months
|
Change in saliva composition
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4 months
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Efficacy: Change in subjective assessment of xerostomia
Time Frame: 4 months
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Change in subjective assessment of xerostomia evaluated by Visual Analog Scale (VAS) questionnaire
|
4 months
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Efficacy: Change in quality of life
Time Frame: at baseline and 4 weeks and 4 months after intervention
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Change in quality of life evaluated by QLQ-H&N-35 questionnaire
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at baseline and 4 weeks and 4 months after intervention
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Efficacy: performance of MSCs application
Time Frame: 4 months
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Assessed by salivary gland scintigraphy with [99mTc]Tc-HMPAO labeled MSCs
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4 months
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Efficacy: Salivary gland function
Time Frame: 4 months
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Assessed by salivary gland scintigraphy with pertechnetate ([99mTc]TcO4-)
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4 months
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Efficacy: salivary gland appearance
Time Frame: 4 months
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Assessed by magnetic resonance imaging and ultrasonography
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4 months
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Efficacy: salivary gland structure
Time Frame: 4 months
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Assessed by histopathological examination of salivary gland tissue sample
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
August 5, 2023
First Submitted That Met QC Criteria
August 22, 2023
First Posted (Actual)
August 25, 2023
Study Record Updates
Last Update Posted (Actual)
August 25, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERIDNPVO-0038/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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