Status:
UNKNOWN
Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells
Lead Sponsor:
Institute of Oncology Ljubljana
Collaborating Sponsors:
Blood Transfusion Centre of Slovenia
University Medical Centre Ljubljana
Conditions:
Xerostomia Following Radiotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 po...
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-rand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06012604
Start Date
September 1 2023
End Date
August 1 2025
Last Update
August 25 2023
Active Locations (4)
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1
Blood Transfusion Center of Slovenia
Ljubljana, Slovenia, SI-1000
2
Institute of Oncology Ljubljana
Ljubljana, Slovenia, SI-1000
3
University Clinical Center Ljubljana
Ljubljana, Slovenia, SI-1000
4
University of Ljubljana
Ljubljana, Slovenia, SI-1000