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

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).

Timeline

Start

2026-07-01

Primary completion

2027-06-30

Completion

2027-06-30

Publications

• Background 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.
• 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.
• 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.

Drugs

Indications