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Multi-center clinical study of ear & nose reconstruction using tissue engineering cartilage transplantation

Multi-center clinical study of ear & nose reconstruction using tissue engineering cartilage transplantation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036707
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Maxillofacial deformities

Interventions

Experimental Group of ear reconstruction:Tissue engineering ear cartilage reconstruction
Experimental Group of nose reconstruction:Tissue engineering nose cartilage reconstruction

Sponsors

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria of ear reconstruction 1. The first diagnosis must conform to the ICD - 10: Q17.20 patients with congenital microtia malformation; 2. Aged 6 to 60 years; 3. Health, always without systemic disease; 4. Patients with small ear deformity index for level I and II; Inclusion criteria of nose reconstruction 1. Primary diagnosis is either nasal defect, nasal deformity or in need for rhinoplasty; 2. Aged 6-60 years, no gender requirement; 3. No surgical contraindication(s) such as systemic diseases.

Exclusion criteria

Exclusion criteria: Exclusion criteria of ear reconstruction 1. general condition is poor; 2. local hormone therapy within 3 months; 3. blood or bleeding tendency; 4. drug addiction (including poison, anesthetic and alcohol addiction); 5. scar, allergic constitution; 6. contagious viral infection; 7. with symptoms of fever, colds and other infections in nearly a month; 8. pregnant or lactating women, or plan in the first registration within one year after pregnancy; 9. patients with mental disorders, who can't cooperate with rehabilitation; 10. the poor development of attending craniofacial and facial nerve; 11. patients with malformations of other organs. Exclusion criteria of nose reconstruction 1. under poor physical condition, or preexisting contraindication(s) to surgical procedure such as systemic diseases; 2. Poor craniofacial and facial nerve development; 3. Tumor patients, life expectancy <5 years or occurrence of malignant tumor within past 10 years; 4. Suffering from hematological disease or bleeding tendency disease; 5. Major active infection or infectious viral infection; 6. Pregnancy, breastfeeding or have pregnancy intentions; 7. Preexisting of mental illness and cannot cooperate with rehabilitation treatment; 8. Drug addiction (including drug, narcotic and alcohol addiction); 9. Post operation of major organs within 6 weeks , or impaired surgical wound healing; 10. Currently participating in other clinical trial; 11. Other situations that are considered not suitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
physical examination;facial development;imaging;chemistry tests;other specialized examinations;

Countries

China

Contacts

Public ContactGuangdong Zhou

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine

guangdongzhou@126.com+86 13818248439

Outcome results

None listed

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