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Nasal inhaled umbilical cord MSC-derived exosomes for pediatric allergic rhinitis
ChiCTR2600123791Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Apr 2026
- Countries
- 1
- Sponsor
- Shenzhen Baoan Women's and Children's Hospital
- Modality
- Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Conditions
- allergic rhinitis (AR)
01
Overview
Phase 2, randomised, double-blind trial of human umbilical cord mesenchymal stem cell-derived exosomes in allergic rhinitis (AR) (4 arms), sponsored by Shenzhen Baoan Women's and Children's Hospital. Primary endpoints: Reflective Total Nasal Symptom Score (rTNSS) and Safety and tolerability. Planned start Apr 2026; status: not yet recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
HUCMSC-EXOs low dose
Nasal atomization inhalation of 1×10^9 particles in 5 mL per dose every 2 days for 4 weeks.
HUCMSC-EXOs medium dose
Nasal atomization inhalation of 1×10^10 particles in 5 mL per dose every 2 days for 4 weeks.
HUCMSC-EXOs high dose
Nasal atomization inhalation of 1×10^11 particles in 5 mL per dose every 2 days for 4 weeks.
Placebo (normal saline)
Nasal atomization inhalation of 5 mL normal saline per dose every 2 days for 4 weeks.
03
Who it enrols
Children aged 6–14 years with moderate-to-severe persistent allergic rhinitis, positive allergen testing (skin prick or serum specific IgE), and an rTNSS score ≥ 8 at screening. Excludes asthma, significant nasal structural disease, recent infections or nasal surgery, recent biologic or allergen immunotherapy, recent use of multiple anti-allergic medications, autoimmune disease, severe systemic or specific infections, long-term immunosuppression, pregnancy/lactation, recent participation in another clinical trial, and known allergy to investigational product components.
04
Endpoints
Primary
Reflective Total Nasal Symptom Score (rTNSS)
Safety and tolerability
Secondary
Nasal ventilation function
Olfactory function
Use of allergic rhinitis medications
Inflammatory factors in nasal secretions (IL-4, IL-5)
Specific IgE in nasal lavage fluid
Nasal mucosa status
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
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