Pediatric Nasal Deformities
Conditions
Interventions
Human reconstructed elastic cartilage, cultured and manufactured from the patient's own auricular perichondrium tissue, will be surgically transplanted into the nasal deformity site with a maximum of
Sponsors
Kobayashi Shinji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with congenital pediatric facial deformities requiring augmentation rhinoplasty and nasal tip surgery. 2)Patients aged 6 to 12 years at the time of consent by a legally authorized representative (any gender). 3)Patients weighing at least 18 kg. 4)Patients able to attend outpatient visits on the protocol-specified dates. 5)Patients with written consent from a legally authorized representative and, where possible, assent from the patient (written or verbal).
Exclusion criteria
Exclusion criteria: 1)Patients who test positive or are suspected to be positive for hepatitis B, hepatitis C, syphilis, human immunodeficiency virus (HIV), or human T-cell leukemia virus type 1 (HTLV-1) 2)Patients classified as Class 3 or higher in the American Society of Anesthesiologists Physical Status (ASA-PS) classification 3)Patients who have or are suspected to have malignant tumors 4)Patients with diabetes 5)Patients who have or are suspected to have infectious diseases or sepsis. However, patients with infections expected to recover quickly, such as the common cold or influenza, are not excluded (i.e., they are eligible). 6)Patients suspected of having a local infection at the surgical site (tissue collection or transplantation site) 7)Patients who have or are suspected to have immunodeficiency disorders (primary or secondary) or autoimmune diseases 8)Patients with bleeding tendencies or disorders (e.g., hemophilia, coagulation abnormalities) 9)Patients with a history of anaphylactic reactions 10)Patients who have had or are suspected to have hypersensitivity or allergies to collagen products, fibroblast growth factor products, insulin-like growth factor products, penicillin or aminoglycoside antibiotics, or animals from which raw materials are derived (e.g., bovine, porcine) 11)Patients who already have any material implanted at the transplantation site 12)Patients who have received any of the following agents within 12 weeks prior to consent: fibroblast growth factor 2 (FGF-2), parathyroid hormone, insulin-like growth factor 1 (IGF-1), growth hormone, sex hormones (female/male), thyroid hormone, interleukin-1 receptor antagonist, vitamin D (excluding supplements), or steroids (excluding topical formulations) 13)Patients currently participating in another clinical trial, those who participated in another clinical trial within 4 weeks prior to consent, or those planning to participate in another clinical trial during this study 14)Female patients who are pregnant or suspected to be pregnant 15)Patients deemed unsuitable for participation by the investigator, such as cases where the guardian is considered unable to provide appropriate care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects who experienced adverse events for which a causal relationship with the investigational product or its malfunction cannot be ruled out | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Status of the following adverse events (number of affected subjects, number of events, severity, seriousness): All adverse events Adverse events for which a causal relationship with the protocol treatment cannot be ruled out Adverse events for which a causal relationship with the tissue harvesting procedure cannot be ruled out Adverse events for which a causal relationship with the transplantation procedure cannot be ruled out Efficacy: Number of subjects who showed augmentation effect at the nasal tip on cephalogram Presence or absence of hyperplasia or hypertrophy as determined by MRI | — |
Contacts
Public ContactShinji Kobayashi
Kanagawa Children's Medical Center
Outcome results
None listed