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

NCT06012604 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-25

No results posted yet for this study

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

Interventions

BIOLOGICAL

allogeneic mesenchymal stromal stem cells

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

Sponsors & Collaborators

  • Blood Transfusion Centre of Slovenia

    collaborator OTHER_GOV

  • University Medical Centre Ljubljana

    collaborator OTHER

  • University of Ljubljana

    collaborator OTHER

  • Institute of Oncology Ljubljana

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06012604 on ClinicalTrials.gov