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

7 juin 2026 mis à jour par: The First Affiliated Hospital of Xinxiang Medical College

A Single-Centre, Randomised, Double-Blind, Placebo-Controlled Exploratory Clinical Study of a Thermosensitive Gel Nasal Spray Loaded With Umbilical Cord Mesenchymal Stem Cell Exosomes, Mupirocin and DNase I for the Treatment of Chronic Rhinosinusitis (Chronic Type Without Polyps)

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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is an exploratory, single-centre, randomised, double-blind, placebo-controlled clinical study. A total of 108 participants (allowing for 20% dropout) will be enrolled and allocated in a 1:1:1 ratio to three parallel groups:

  • Group A (triple combination): thermosensitive gel + human umbilical cord mesenchymal stem cell exosomes (hUC-MSC-Exo, 1×10^10 particles/mL) + mupirocin (2%) + DNase I (0.1%).
  • Group B (dual control): gel + mupirocin (2%) + DNase I (0.1%).
  • Group C (placebo): blank gel matrix only. The gel matrix consists of Poloxamer 407 (18%) and chitosan hydrochloride (0.5%) in sterile phosphate-buffered saline (PBS, pH 6.4-6.8). At room temperature it is a liquid; upon contact with the nasal mucosa (33-35°C) it forms a semi-solid gel within 30 seconds, enabling sustained release.

Participants aged 18-65 years with diagnosed chronic rhinosinusitis (CRS) without polyps (duration >12 weeks), Lund-Kennedy secretion score ≥1, positive nasal culture for Staphylococcus aureus, and Sino-Nasal Outcome Test-22 (SNOT-22) score ≥30 are eligible. Key exclusion criteria include sinus surgery within 6 months, nasal polyps, Pseudomonas aeruginosa as the primary pathogen, use of systemic antibiotics/immunosuppressants within 4 weeks, and pregnancy.

The treatment period is 28 days, with twice-daily dosing (morning and evening). Each dose: 2 sprays per nostril (50 microlitres per spray). Single-spray dose: exosomes 2×10^9 particles, mupirocin 4 mg, DNase I 0.2 mg. Daily total doses are doubled.

Study visits include screening (day -7 to 0), treatment (days 1, 7, 14, 21), end-of-treatment (day 29±2), short-term follow-up (day 42±3), and long-term follow-up (day 90±7). Primary outcome: safety assessed by adverse events (Common Terminology Criteria for Adverse Events version 5.0, CTCAE v5.0). Secondary outcomes: bacterial clearance rate of Staphylococcus aureus, change in neutrophil extracellular traps (NETs) levels measured by MPO-DNA enzyme-linked immunosorbent assay (ELISA), mucus viscosity (rheometer), endoscopic Lund-Kennedy score (0-20, higher=worse), SNOT-22 score (0-110, higher=worse), visual analog scale (VAS) symptom diary (0-10, higher=worse), and number of acute exacerbations. Exploratory outcomes include biofilm disruption (electron microscopy), inflammatory cytokines (interleukin-8, IL-8; interleukin-17, IL-17; tumour necrosis factor-alpha, TNF-α; interleukin-10, IL-10), tight junction proteins (zonula occludens-1, ZO-1; occludin), 16S ribosomal RNA (rRNA) microbiome diversity, and mupirocin susceptibility testing.

The trial will be conducted at The First Affiliated Hospital of Henan Medical University (Zhongyuan Regenerative Medicine Laboratory). It has received ethical approval from the Ethics Committee of The First Affiliated Hospital of Henan Medical University (approval number: 2026-30). The study will adhere to Good Clinical Practice (GCP), the Declaration of Helsinki, and local regulations. Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed publications.

Type d'étude

Interventionnel

Inscription (Estimé)

108

Phase

  • Première phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 18 to 65 years, both genders
  • Diagnosis of chronic rhinosinusitis without nasal polyps according to Chinese guidelines (2018), duration >12 weeks
  • Nasal endoscopy shows purulent secretions (Lund-Kennedy secretion score ≥1)
  • Nasal secretion culture positive for Staphylococcus aureus
  • Sino-Nasal Outcome Test-22 (SNOT-22) score ≥30
  • Voluntary signed informed consent

Exclusion Criteria:

  • Sinus surgery within past 6 months, or anatomical abnormalities requiring reoperation
  • Confirmed allergic fungal rhinosinusitis, odontogenic rhinosinusitis, or nasal polyps
  • Nasal discharge culture indicating Pseudomonas aeruginosa as primary pathogen
  • Primary ciliary dyskinesia, cystic fibrosis, or severe immunodeficiency
  • Use of systemic antibiotics or immunosuppressants within past 4 weeks
  • Use of intranasal corticosteroids within past 2 weeks
  • Hypersensitivity to mupirocin, DNase I, or any component of the formulation
  • Severe renal impairment (estimated Glomerular Filtration Rate, eGFR <60 mL/min/1.73 m²)
  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • Uncontrolled severe systemic diseases (diabetes, hypertension, autoimmune diseases)
  • Malignancy within past 5 years
  • Participation in other clinical trials

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Triple Combination (Exosomes + Azelastine + Interferon)
Participants receive the thermosensitive gel nasal spray containing human umbilical cord mesenchymal stem cell exosomes (hUC-MSC-Exo, 1×10^10 particles/mL), mupirocin (2%), and DNase I (0.1%). Two sprays per nostril, twice daily for 28 days.
Médicament: Exosomes (hUC-MSC-Exo)
Umbilical cord mesenchymal stem cell exosomes, 1×10^10 particles/mL, in thermosensitive gel nasal spray.
Médicament: Mupirocin
Mupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.
Médicament: DNase I
DNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.
Comparateur actif: Triple Combination (Exosomes + Mupirocin + DNase I)
Participants receive the thermosensitive gel nasal spray containing mupirocin (2%) and DNase I (0.1%). Two sprays per nostril, twice daily for 28 days.
Médicament: Mupirocin
Mupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.
Médicament: DNase I
DNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.
Comparateur placebo: Placebo (Gel Matrix Only)
Participants receive the blank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS) without active ingredients. Two sprays per nostril, twice daily for 28 days.
Médicament: Placebo Gel Matrix
Blank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants with Treatment-Related Adverse Events
Délai: From baseline up to day 90 (long-term follow-up)
Local adverse events (epistaxis, nasal irritation, burning sensation, dryness), systemic adverse events (headache, nausea, allergic reactions), and changes in laboratory parameters (complete blood count, liver function, kidney function) graded according to CTCAE Version 5.0.
From baseline up to day 90 (long-term follow-up)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Staphylococcus aureus Clearance Rate
Délai: Day 29
Proportion of participants with negative nasal culture for Staphylococcus aureus at end of treatment.
Day 29
Change in Neutrophil Extracellular Traps (NETs) Levels
Délai: Baseline and Day 29
Measured by MPO-DNA complex ELISA in nasal lavage fluid.
Baseline and Day 29
Change in Nasal Mucus Viscosity
Délai: Baseline and Day 29
Assessed by rotational rheometer.
Baseline and Day 29
Change in Lund-Kennedy Endoscopic Score
Délai: Baseline, Day 29, and Day 42
Lund-Kennedy Endoscopic Score. Minimum value 0 (normal), maximum value 20 (most severe inflammation). Higher scores mean a worse outcome. This scale assesses polyps, oedema, discharge, scarring, and crusting. The score is used to evaluate nasal mucosal inflammation.
Baseline, Day 29, and Day 42
Change in SNOT-22 Score
Délai: Baseline, Day 29, Day 42, and Day 90
Sino-Nasal Outcome Test-22 (SNOT-22) Score. Minimum value 0 (no symptoms), maximum value 110 (worst possible symptoms). Higher scores mean a worse outcome. It measures symptom severity and quality of life in patients with chronic rhinosinusitis.
Baseline, Day 29, Day 42, and Day 90
Number of Acute Exacerbations
Délai: Up to Day 90
Number of acute exacerbations requiring antibiotic or steroid treatment within 3 months of follow-up.
Up to Day 90

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The First Affiliated Hospital of Xinxiang Medical College

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

30 juin 2027

Achèvement de l'étude (Estimé)

30 juin 2027

Dates d'inscription aux études

Première soumission

30 mai 2026

Première soumission répondant aux critères de contrôle qualité

7 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HAHMU-CRS-3Combo

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

This is a single-centre exploratory study with a small sample size (N=108). The data contain sensitive participant information and are subject to local privacy regulations. No formal data sharing agreement is planned.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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