AuriNovo for Auricular Reconstruction

NCT04399239 | Terminated Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 3DBio12A2020
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Microtia

Keywords

ear reconstruction

Outcome Measures

Primary Outcomes (3)

• Safety through assessment of AEs

  Safety data will be collected on AE type, frequency and severity, treatment, and the time to resolution.

  3 months

• Efficacy as measured through overall satisfaction scores

  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))

  3 months

• Efficacy as measured through overall satisfaction scores

  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; \- FACE-Q Kids Questionnaire (scores range from 74 (lowest satisfaction) to 296 (highest satisfaction))

  3 months

Study Arms (1)

AuriNovo

EXPERIMENTAL

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.

Combination Product: AuriNovo

Interventions

AuriNovo COMBINATION_PRODUCT

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.

Also known as: AACC

AuriNovo

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3DBio Therapeutics: lead

Study Sites (2)

John Reinisch, MD

Beverly Hills, California, 90211, United States

Location

Microtia-Congenital Ear Deformity Institute

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: August 9, 2021
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: March 4, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)