Chronic rhinosinusitis
Conditions
Interventions
Low-dose group (LDG) , Medium-dose group (MDG) , High-dose group (HDG):First Cycle - Low-dose Group (LDG):
Enrolled subjects: 3
Administration: Intranasal delivery twice daily (morning and evening)
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Informed Consent & Compliance:Understand and sign the informed consent form prior to participation, and comply with all study requirements. 2)Age:18–70 years old. 3)Diagnosis of CRSwNP (EPOS2020 Criteria) with Type 2 Inflammation. Must meet at least 4 of the following 6 criteria: (1) Blood eosinophil (EOS) count >0.25×10^9/L or percentage >4.5%;(2) Serum total IgE >60 IU/mL;(3) SNOT-22 score >= 40; (4) Comorbid asthma requiring regular inhaled corticosteroid (ICS) treatment; (5) Loss of smell; (6) Previous oral corticosteroid (OCS) therapy for CRSwNP. 4)Nasal Polyp Score (NPS):Total NPS >= 4 (with unilateral score >= 2). 5)Contraception Requirements for Female Participants. Eligible women must meet one of the following:No pregnancy potential (e.g., postmenopausal, surgically sterilized); OR If of childbearing potential:Negative urine pregnancy test at baseline;Agreement to use highly effective contraception during the study and for 30 days after treatment completion.Male participants with partners of childbearing potential must also use effective contraception until 30 days post-treatment.
Exclusion criteria
Exclusion criteria: 1. Nasal/Sinus Tumors or Other Systemic Conditions: Presence of nasal/sinus tumors, fungal sinusitis, or immunodeficiency disorders. 2. Recent Upper Respiratory Infection (URI): History of URI within the past month. 3.Active or Chronic Infections: Hepatitis B (HBsAg, HBeAg, anti-HBe, or anti-HBc positive), hepatitis C (anti-HCV positive), syphilis (serum antibody positive), or HIV infection (anti-HIV positive). 4.Recent Participation in Another Clinical Trial: Currently or within the past 6 months, participated in another investigational drug/device study. 5.Prior Stem Cell Therapy: Previous participation in any stem cell-based clinical research. 6. Recent Use of Systemic Corticosteroids or Biologics: Received oral corticosteroids or biologic therapy within the past 6 months. 7. Allergies or Renal Impairment: Known allergy to antibiotics or antifungal drugs. Serum creatinine exceeding 2× the upper limit of normal (ULN) at screening. 8.Hepatic Impairment: AST/ALT levels >3× ULN at screening. 9.Investigator’s Discretion: Any other condition deemed by the investigator to make the patient unsuitable for the study. 10.Inability or Unwillingness to Provide Consent: Individuals who cannot or refuse to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in nasal polyp size (Nasal Polyp Score, NPS); | — |
Countries
China
Contacts
Public ContactWei Lv
Department of Otolaryngology-Head and Neck Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China
Outcome results
None listed