Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells

NCT06012604 | Unknown Phase 1

• 1 other identifier: ERIDNPVO-0038/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Xerostomia Following Radiotherapy

Keywords

post-radiation xerostomia; allogenic mesenchyma stromal stem cells; toxicity; effectiveness

Outcome Measures

Primary Outcomes (1)

• Safety: Number of patients with serious adverse events

  Registration of number of patients with serious adverse events in a 4 months follow-up period

  4 months

Secondary Outcomes (8)

• Efficacy: Change in unstimulated and stimulated whole salivary flow rate

  4 months

• Efficacy: Change in saliva composition

  4 months

• Efficacy: Change in subjective assessment of xerostomia

  4 months

• Efficacy: Change in quality of life

  at baseline and 4 weeks and 4 months after intervention

• Efficacy: performance of MSCs application

  4 months

Study Arms (1)

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.

Biological: allogeneic mesenchymal stromal stem cells

Interventions

allogeneic mesenchymal stromal stem cells BIOLOGICAL

mesenchymal stromal stem cells injection under ultrasound guidance into parotid and submandibular glands

allogeneic mesenchymal stromal stem cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead
• Blood Transfusion Centre of Slovenia: collaborator
• University Medical Centre Ljubljana: collaborator
• University of Ljubljana: collaborator

Study Sites (4)

Blood Transfusion Center of Slovenia

Ljubljana, SI-1000, Slovenia

Location

Institute of Oncology Ljubljana

Ljubljana, SI-1000, Slovenia

Location

University Clinical Center Ljubljana

Ljubljana, SI-1000, Slovenia

Location

University of Ljubljana

Ljubljana, SI-1000, Slovenia

Location

Central Study Contacts

Primož Strojan, Prof.

CONTACT

+38615879290; pstrojan@onko-i.si

Violeta Kaluža

CONTACT

+38615879122; vkaluza@onko-i.si

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: intervention group control group

Study Record Dates

• First Submitted: August 5, 2023
• First Posted: August 25, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (4)