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Study on the Efficacy and Safety of Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Xerostomia after Radiotherapy for Nasopharyngeal Carcinoma

Study on the Efficacy and Safety of Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Xerostomia after Radiotherapy for Nasopharyngeal Carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107372
Enrollment
Unknown
Registered
2025-08-11
Start date
2026-01-25
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia after radiotherapy for nasopharyngeal carcinoma

Interventions

Research Group:Local injection of stem cell exosomal preparation agent

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old < age < 70 years old; 2. The general condition is good and you can cooperate with all kinds of examinations; 3. Patients diagnosed with nasopharyngeal carcinoma by histology and pathology; 4. Nasopharyngeal carcinoma patients who have achieved complete remission (CR) after radical radiotherapy and chemotherapy and have remained stable for = 6 months; 5. MRI or other imaging examinations have confirmed that there is no recurrence, lymph node metastasis or distant metastasis of the primary lesion; 6. At rest, the saliva secretion was less than 0.20ml/min, and obvious symptoms such as dry mouth and dysphagia occurred. There was a temporal correlation between the above symptoms and radiotherapy; 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Suffering from a serious mental illness and lacking autonomy; 3.It can be combined with other diseases that can cause dry mouth symptoms, such as Sjogren's syndrome and salivary gland stones; 4.Take anticholinergic drugs; 5.Poor overall condition, or accompanied by severe systemic infection; 6.Has a history of severe allergies in the past; 7.Other malignant tumors are present throughout the body; 8.Currently undergoing high-risk treatments such as anticoagulation and dialysis; 9.Long-term use of high-dose glucocorticoids within the past three months; 10.There is a history of cerebral hemorrhage or cerebral infarction within six months; 11.There is a history of unstable angina pectoris or myocardial infarction within 6 months;

Design outcomes

Primary

MeasureTime frame
The variation level of salivary secretion flow rate at rest and under stimulation;

Secondary

MeasureTime frame
Changes in the inner diameter (D) of the branch vessels of the submandibular gland of the facial artery;Exosome injection safety: including adverse events (AE) and serious adverse events (SAE);Changes in peak systolic blood flow velocity (PSV) of the submandibular gland branch of the facial artery;Changes in the branch vascular resistance index (RI) of the submandibular gland of the facial artery;Changes in the end-diastolic blood flow velocity (EDV) of the branch arteries of the submandibular gland in the facial artery;Volume changes of the submandibular gland;Changes in the scores of the Anderson Dysphagia Scale Questionnaire (MDADI);Changes in the score of the Dry Mouth Related Quality of Life Scale (XeQOL);

Countries

China

Contacts

Public ContactDesheng Wang

Fujian Medical University Union Hospital

fzwangdesheng@163.com+86 591 86218033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026