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

7. juni 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

108

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Exosomes (hUC-MSC-Exo)
Umbilical cord mesenchymal stem cell exosomes, 1×10^10 particles/mL, in thermosensitive gel nasal spray.
Legemiddel: Mupirocin
Mupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.
Legemiddel: DNase I
DNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.
Aktiv komparator: 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.
Legemiddel: Mupirocin
Mupirocin 2% (20 mg/mL) in thermosensitive gel nasal spray.
Legemiddel: DNase I
DNase I 0.1% (1 mg/mL) in thermosensitive gel nasal spray.
Placebo komparator: 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.
Legemiddel: Placebo Gel Matrix
Blank thermosensitive gel matrix (Poloxamer 407 18% + chitosan hydrochloride 0.5% in PBS).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants with Treatment-Related Adverse Events
Tidsramme: 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)

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

30. mai 2026

Først innsendt som oppfylte QC-kriteriene

7. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HAHMU-CRS-3Combo

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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