Status:
TERMINATED
AuriNovo for Auricular Reconstruction
Lead Sponsor:
3DBio Therapeutics
Conditions:
Microtia
Eligibility:
All Genders
6-25 years
Phase:
PHASE1
PHASE2
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 conduc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04399239
Start Date
August 9 2021
End Date
May 18 2023
Last Update
March 4 2024
Active Locations (2)
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1
John Reinisch, MD
Beverly Hills, California, United States, 90211
2
Microtia-Congenital Ear Deformity Institute
San Antonio, Texas, United States, 78240