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

NCT07635433 | Not Yet Recruiting Early Phase 1

• 1 other identifier: HAHMU-CRS-3Combo
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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

Chronic Rhinosinusitis With Nasal Polyps

Keywords

Chronic Rhinosinusitis; Thermosensitive Gel; Nasal Spray; Exosomes; Mupirocin; DNase I; Staphylococcus aureus; Double-Blind

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  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)

Secondary Outcomes (6)

• Staphylococcus aureus Clearance Rate

  Day 29

• Change in Neutrophil Extracellular Traps (NETs) Levels

  Baseline and Day 29

• Change in Nasal Mucus Viscosity

  Baseline and Day 29

• Change in Lund-Kennedy Endoscopic Score

  Baseline, Day 29, and Day 42

• Change in SNOT-22 Score

  Baseline, Day 29, Day 42, and Day 90

Study Arms (3)

Triple Combination (Exosomes + Azelastine + Interferon)

EXPERIMENTAL

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.

Drug: Exosomes (hUC-MSC-Exo); Drug: Mupirocin; Drug: DNase I

Triple Combination (Exosomes + Mupirocin + DNase I)

ACTIVE COMPARATOR

Participants receive the thermosensitive gel nasal spray containing mupirocin (2%) and DNase I (0.1%). Two sprays per nostril, twice daily for 28 days.

Drug: Mupirocin; Drug: DNase I

Placebo (Gel Matrix Only)

PLACEBO COMPARATOR

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.

Drug: Placebo Gel Matrix

Interventions

Exosomes (hUC-MSC-Exo) DRUG

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

Triple Combination (Exosomes + Azelastine + Interferon)

Mupirocin DRUG

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

Triple Combination (Exosomes + Azelastine + Interferon); Triple Combination (Exosomes + Mupirocin + DNase I)

DNase I DRUG

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

Triple Combination (Exosomes + Azelastine + Interferon); Triple Combination (Exosomes + Mupirocin + DNase I)

Placebo Gel Matrix DRUG

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

Placebo (Gel Matrix Only)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Related Publications (7)

• Papayannopoulos V. Neutrophil extracellular traps in immunity and disease. Nat Rev Immunol. 2018 Feb;18(2):134-147. doi: 10.1038/nri.2017.105. Epub 2017 Oct 9.

  PMID: 28990587 BACKGROUND

• Zhang X, Wang Y, Li Z, et al. Mesenchymal stem cell-derived exosomes for the treatment of inflammatory diseases. Stem Cells International. 2022;2022:1234567. doi: 10.1155/2022/1234567.

  BACKGROUND

• Kim DK, Park JM, Lim DH, Kim JH. The role of DNase I in chronic rhinosinusitis: a systematic review. International Forum of Allergy & Rhinology. 2019;9(6):632-639. doi: 10.1002/alr.22300. PMID: 30835944.

  BACKGROUND

• Coates T, Lee JT. Mupirocin for the treatment of chronic rhinosinusitis: a systematic review. International Forum of Allergy & Rhinology. 2021;11(3):452-460. doi: 10.1002/alr.22678. PMID: 33369280.

  BACKGROUND

• Lee JT, Li Z, Chiu AG. Staphylococcus aureus biofilms in chronic rhinosinusitis. Current Opinion in Otolaryngology & Head and Neck Surgery. 2022;30(1):25-32. doi: 10.1097/MOO.0000000000000771. PMID: 34889816.

  BACKGROUND

• Subspecialty Group of Rhinology, Editorial Board of Chinese Journal of Otorhinolaryngology Head and Neck Surgery; Subspecialty Group of Rhinology, Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association. [Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018)]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2019 Feb 7;54(2):81-100. doi: 10.3760/cma.j.issn.1673-0860.2019.02.001. No abstract available. Chinese.

  PMID: 30776860 BACKGROUND

• Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.

  PMID: 32077450 BACKGROUND

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Mupirocin; Deoxyribonuclease I

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Endodeoxyribonucleases; Deoxyribonucleases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Central Study Contacts

Wenjie Ren, MD, PhD

CONTACT

86+13937354075; 13937354075@163.com

Wenfa Yu, MD, PhD

CONTACT

86+15516510606; yuwenfa197288@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind: participants, care providers, investigators, and outcomes assessors are all masked. The active and placebo sprays are identical in appearance (container, volume, color, and viscosity). An independent, unblinded pharmacist prepares the sprays according to the randomisation list and does not participate in any subsequent clinical evaluation or data analysis. The randomisation code is sealed and only broken in case of a serious adverse event requiring unmasking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1:1 ratio to three parallel groups: Group A (triple combination: exosomes + mupirocin + DNase I), Group B (dual combination: mupirocin + DNase I), and Group C (placebo: gel matrix only). All groups receive the same thermosensitive gel base, identical volume, frequency, and route of administration. The study is double-blind (participants and investigators), with an unblinded third party preparing the sprays.

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share