A Multicenter, Single Arm, Prospective, Open-Label, Staged Study of the Safety and Efficacy of the AuriNovo Construct for Auricular Reconstruction in Subjects With Unilateral Microtia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Safety through assessment of AEs
研究概览
简要总结
AuriNovo provides a patient-specific, biological construct for use in the surgical reconstruction of the external ear in people born with microtia Grades II-IV. This Phase 1 / 2A study is being conducted to collect preliminary safety data on microtic ear reconstruction using AuriNovo, fine-tune technical, logistical, surgical, and post-surgical care aspects related to implantation, and to gather preliminary efficacy data including short- and longer-term in vivo duration and biological status of the implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric children 6-11, adolescents 12-16, or adults 17-25 years old
- •Born with unilateral microtia Grade II, III, or IV
- •No previous surgical procedure for auricular reconstruction
- •Have undergone an audiological assessment prior to enrollment and surgeon confirmation that study participation will not preclude future hearing correction options
- •Normal or near normal hairline position
- •Able to adhere to the follow-up schedule and post-surgery care instructions
- •Ability for the subject and/or guardian to understand and give informed consent
- •Healthy subjects with no history of cancer, problematic wound healing, or immune disorders
排除标准
- •Previous cochlear implant surgery
- •Patients with prior surgery in the temporal, parietal, or mastoid regions of the affected side that resulted in scarring that may affect the outcome of microtia reconstruction surgery.
- •Sensitivity to broad-spectrum aminoglycoside antibiotics containing any of the following: streptomycin, gentamycin tobramycin, amikacin, kanamycin, neomycin, or plazomicin.
- •Sensitivity to materials of porcine origin including pork products. For subjects with no known exposure to porcine materials including pork products, sensitivity as confirmed at baseline through a positive porcine skin sensitivity test.
- •Patients previously diagnosed/evaluated for any of the following syndromes:
- •CHARGE (Coloboma, Heart defect, choanal Atresia, Retarded growth and development, Genital hypoplasia, Ear anomalies) syndrome,
- •Branchio-oto-renal (BOR) syndrome
- •Patients with renal dysfunction of any etiology
- •Patients with abnormal renal function determined at baseline with a blood test.
- •Patients with a history of keloid formation.
- •Patients with current skin infection.
- •Patients on immunosuppressants.
- •Any cognitive disorders where the patient would not be able to complete subject assessment questionnaires.
- •Lifestyle activities likely to affect healing or ability to adhere to the protocol (e.g., active contact sports and protective gear interferes with wearing post-operative ear protection)
- •Patients requiring chronic use of any headgear (e.g., CPAP) that would interfere with the ability to wear post-operative ear protection.
- •Pregnant females (a negative pregnancy test is required for females with reproductive potential)
- •Female patients who are nursing/lactating
- •Patients of reproductive potential (male and female) unwilling to use effective contraception during the first post-operative year.
- •For this first-in-human study, microtia patients with significant craniofacial asymmetries or deformities from other syndromes will be excluded in order to aid initial assessments of efficacy of AuriNovo. The following syndromes or conditions are additional exclusion factors:
- •Treacher-Collins Syndrome
- •Nager Syndrome
- •Goldenhar syndrome or hemifacial microsomia plus an occlusal cant of 20 degrees or greater
- •Absence of vertical ramus (as diagnosed on physical exam or CT)
- •Absence of zygoma (as diagnosed on physical exam or CT)
- •Significant orbital asymmetry or micro-ophthalmia (as diagnosed on physical exam or CT)
研究组 & 干预措施
AuriNovo
AuriNovo is a patient-specific, biologically natural, supportive base for surgical reconstruction of the external ear (auricle) in people born with microtia Grades II-IV. The construct is a 3D-bioprinted collagen hydrogel scaffold encapsulating the patient's own auricular cartilage cells (chondrocytes). The construct is printed in a size and shape that matches the contralateral ear for implantation into the patient.
干预措施: AuriNovo (Combination Product)
结局指标
主要结局
Safety through assessment of AEs
时间窗: 3 months
Safety data will be collected on AE type, frequency and severity, treatment, and the time to resolution.
Efficacy as measured through overall satisfaction scores
时间窗: 3 months
Data will be collected to determine the suitability of the AACC to support reconstruction of the outer ear in microtia patients. The following will be used to determine satisfaction; \- Surgical Outcomes Questionnaire (scores range from 15 (lowest satisfaction) to 75 (highest satisfaction))
次要结局
未报告次要终点