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Application of adipose-derived stem cells in postoperative rehabilitation of chronic sinusitis: a randomized controlled study

Application of adipose-derived stem cells in postoperative rehabilitation of chronic sinusitis: a randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029694
Enrollment
Unknown
Registered
2020-02-09
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-02-10

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

Conditions

Chronic sinusitis

Interventions

experimental group:Inject stem cell fluid into the surgical area
control group:normal saline

Sponsors

Tongji Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Subjects shall be Chinese citizens aged 18 to 60, regardless of gender. 2. Subjects shall meet the diagnostic criteria for chronic sinusitis (Chinese guide for diagnosis and treatment of chronic sinusitis 2018) and meet the surgical indications 3. The subject is in good health and has no clinically significant disease that interferes with the test schedule or operation or affects the safety of the subject. 4. Subjects shall be able to comply with the treatment and follow-up schedule. 5. Fertile female subjects must have negative urine HCG at screening.

Exclusion criteria

Exclusion criteria: 1. Subjects with acute sinusitis and acute nasal infection. 2. Subjects with any clinical abnormalities in vital signs or clinically significant abnormalities in ecg results at screening or baseline follow-up. 3. Subjects with clinically significant cardiovascular, lung, kidney, liver, metabolic disease, hematological or neurological disease, or subjects with impaired immune system. 4. Subjects suffering from upper respiratory tract infection. 5. Subjects with septal deviation requiring corrective surgery. 6. Subjects are members of the research team directly involved in this study. 7. Subjects with nasal vestibular inflammation, nasal tumor and other nasal diseases. 8. Subjects plan to get pregnant within three months 9. Subjects who have participated in clinical drug trials within three months. 10. Subjects who used drugs that may affect the results of the test and stop for less than the prescribed time.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;quality of life (QOL);sinonasal outcome test-20 (SNOT-20);Lund-Kenenedy;Lund-Mackay;

Countries

China

Contacts

Public ContactYu Shaoqing

Tongji Hospital of Tongji University

yu_shaoqing@163.com+86 13916455012

Outcome results

None listed

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