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

7 juni 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

108

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Exosomes (hUC-MSC-Exo)
Umbilical cord mesenchymal stem cell exosomes, 1×10^10 particles/mL, in thermosensitive gel nasal spray.
Geneesmiddel: Mupirocin
Mupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.
Geneesmiddel: DNase I
DNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.
Actieve vergelijker: 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.
Geneesmiddel: Mupirocin
Mupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.
Geneesmiddel: DNase I
DNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.
Placebo-vergelijker: 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.
Geneesmiddel: Placebo Gel Matrix
Blank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants with Treatment-Related Adverse Events
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Staphylococcus aureus Clearance Rate
Tijdsspanne: 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
Tijdsspanne: Baseline and Day 29
Measured by MPO-DNA complex ELISA in nasal lavage fluid.
Baseline and Day 29
Change in Nasal Mucus Viscosity
Tijdsspanne: Baseline and Day 29
Assessed by rotational rheometer.
Baseline and Day 29
Change in Lund-Kennedy Endoscopic Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to Day 90
Number of acute exacerbations requiring antibiotic or steroid treatment within 3 months of follow-up.
Up to Day 90

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

30 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

7 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HAHMU-CRS-3Combo

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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