Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells: a Pilot Study

ERIDNPVO-0038/2023

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.

2023-09-01

2025-08-01

2025-08-01

Not yet recruiting

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'intervention group control group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-08-25