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Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis

NCT07312656 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-31

No results posted yet for this study

Summary

Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. According to the latest data from the International Agency for Research on Cancer (IARC), approximately 650,000 new cases of head and neck cancers are diagnosed globally each year, with about 70% of patients undergoing radiotherapy. RIOM develops through a multistep pathophysiological cascade, including initiation of mucosal injury, signaling amplification, inflammatory response, ulceration, and eventual healing. Ionizing radiation induces DNA damage in oral mucosal epithelial cells, triggering increased apoptosis. This cellular injury promotes the activation and release of pro-inflammatory mediators such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6), compromising the integrity of the mucosal barrier and ultimately leading to ulcer formation. Current clinical management of RIOM remains largely supportive, relying on oral hygiene, nutritional supplementation, and pain control, with no effective prophylactic agents available. Despite extensive research into potential interventions internationally, no drugs specifically approved by the FDA or NMPA for the prevention of RIOM have reached the market. This significant unmet clinical need calls for urgent scientific and therapeutic advancement. This study aims to evaluate the therapeutic efficacy and safety profile of aerosolized exosomes derived from mesenchymal stem cells in the prevention and treatment of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancers. The ultimate objective is to establish a novel and effective therapeutic strategy for clinical application.

Conditions

  • Oral Mucositis (Ulcerative) Due to Radiation

Interventions

DRUG

mesenchymal stem cell-derived exosomes

Mesenchymal Exosome Administration Protocol: 1. Administration Timing: Begin 7 days prior to radiotherapy initiation and continue until 14 days post-radiotherapy completion. 2. Preparation: Remove the exosome vial, open the cap, add 5mL of saline solution, and secure the spray cap. 3. Administration Frequency: 3 times daily (30 minutes after breakfast, lunch, and dinner). 4. Dosage: Approximately 1.5mL per spray. 5. Administration Method: Oral spray. Evenly spray onto the oral mucosal surface. Avoid eating or rinsing for 20 minutes after administration.

Sponsors & Collaborators

  • LiuZhou People's Hospital

    collaborator OTHER

  • First People's Hospital of Yulin

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-06-30
Completion
2028-02-29

Countries

  • China

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 NCT07312656 on ClinicalTrials.gov