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A single-arm clinical study to evaluate the safety and efficacy of intralnasal delivery of mesenchymal stem cell-derived exosome for allergic rhinitis

A single-arm clinical study to evaluate the safety and efficacy of intralnasal delivery of mesenchymal stem cell-derived exosome for allergic rhinitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063022
Enrollment
Unknown
Registered
2022-08-28
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis

Interventions

Group 1 :exosome intrnasal administration

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Allergic rhinitis (2015, Tianjin); 2. Aged 18-65 years; 3. Ineffective or ineffective treatment with standardized antiallergic drugs (including continuous local glucocorticoids, local and oral antihistamines, nasal irrigation, etc.); 4. Voluntarily sign the informed consent, understand and accept the duration of the study, and be able and willing to comply with all requirements, including the planned treatment, follow-up, and other study procedures.

Exclusion criteria

Exclusion criteria: 1. Other diseases of nasal cavity and paranasal sinuses (such as nasal polyps, chronic rhinitis, chronic sinusitis, frame structure malformation, etc.); 2. Pregnancy, diagnosis of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.; 3. Suffering from serious systemic diseases, such as tumors, gastrointestinal ulcers, diabetes, tuberculosis, mental diseases, etc.; 4. Syphilis, leprosy, tuberculosis and other specific infections; 5. Subjects using immunosuppressive agents for a long time; 6. Subjects who have participated in other clinical trials in the past months; 7. Subjects deemed inappropriate to participate in this clinical study by the investigator.

Design outcomes

Primary

MeasureTime frame
Blood routine examination;Serum specific IgE;Serum inflammatory factors;Nasal lavage fluid inflammatory factors;Symptom visual analogue scale score;

Secondary

MeasureTime frame
Life quality score;Endoscopy;Olfactometry;

Countries

China

Contacts

Public ContactChenjie Yu

Nanjing Drum Tower Hospital

entphd@163.com+86 13705168089

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026