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Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic Sinusitis

NCT07635433 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-06-09

No results posted yet for this study

Summary

This study tests a new nasal spray for adults (18-65 years) with chronic rhinosinusitis (CRS) without nasal polyps. The spray contains a temperature-sensitive gel (thermosensitive gel) that turns into a soft gel inside the nose to slowly release three active ingredients: human umbilical cord mesenchymal stem cell exosomes (hUC-MSC-Exo) to help heal the nasal lining, mupirocin (an antibiotic that kills Staphylococcus aureus bacteria), and DNase I (an enzyme that breaks down thick mucus). The study aims to check the safety of this triple combination and see if it can reduce infection, clear mucus, and improve symptoms. Participants will be randomly assigned to one of three groups: triple spray, a dual spray (without exosomes), or a placebo (gel only). The treatment is used twice daily for 4 weeks, with follow-up visits up to day 90. The study is single-centre, double-blind, and placebo-controlled. Outcome measures include safety (adverse events graded by Common Terminology Criteria for Adverse Events version 5.0, CTCAE v5.0), bacterial clearance rate, changes in nasal endoscopy score (Lund-Kennedy), quality of life (Sino-Nasal Outcome Test-22, SNOT-22), and nasal symptom visual analog scale (VAS).

Conditions

Interventions

DRUG

Exosomes (hUC-MSC-Exo)

Umbilical cord mesenchymal stem cell exosomes, 1×10\^10 particles/mL, in thermosensitive gel nasal spray.

DRUG

Mupirocin

Mupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.

DRUG

DNase I

DNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.

DRUG

Placebo Gel Matrix

Blank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS).

Sponsors & Collaborators

  • The First Affiliated Hospital of Xinxiang Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2027-06-30

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Diseases

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 NCT07635433 on ClinicalTrials.gov