We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    aurinovo
Previous Study | Return to List | Next Study

AuriNovo for Auricular Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399239
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2020
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
3DBio Therapeutics

Tracking Information
First Submitted Date  ICMJE May 19, 2020
First Posted Date  ICMJE May 22, 2020
Last Update Posted Date October 18, 2021
Actual Study Start Date  ICMJE August 9, 2021
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • Safety through assessment of AEs [ Time Frame: 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 [ Time Frame: 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))
  • Efficacy as measured through overall satisfaction scores [ Time Frame: 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; - FACE-Q Kids Questionnaire (scores range from 74 (lowest satisfaction) to 296 (highest satisfaction))
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • Safety through assessment of AEs [ Time Frame: 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 [ Time Frame: 3 months ]
    Data will be collected to determine the suitability of the AACC to support reconstruction of the outer ear in microtia patients.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AuriNovo for Auricular Reconstruction
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Microtia
Intervention  ICMJE Combination Product: 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.
Other Name: AACC
Study Arms  ICMJE Experimental: 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.
Intervention: Combination Product: AuriNovo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 19, 2020)
11
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2028
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pediatric children 6-11, adolescents 12-16, or adults 17-25 years old
  2. Born with unilateral microtia Grade II, III, or IV
  3. No previous surgical procedure for auricular reconstruction
  4. Have undergone an audiological assessment prior to enrollment and surgeon confirmation that study participation will not preclude future hearing correction options
  5. Normal or near normal hairline position
  6. Able to adhere to the follow-up schedule and post-surgery care instructions
  7. Ability for the subject and/or guardian to understand and give informed consent
  8. Healthy subjects with no history of cancer, problematic wound healing, or immune disorders

Exclusion Criteria:

  1. Previous cochlear implant surgery
  2. 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.
  3. Sensitivity to broad-spectrum aminoglycoside antibiotics containing any of the following: streptomycin, gentamycin tobramycin, amikacin, kanamycin, neomycin, or plazomicin.
  4. 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.
  5. Patients previously diagnosed/evaluated for any of the following syndromes:

    1. CHARGE (Coloboma, Heart defect, choanal Atresia, Retarded growth and development, Genital hypoplasia, Ear anomalies) syndrome,
    2. Branchio-oto-renal (BOR) syndrome
    3. Patients with renal dysfunction of any etiology
  6. Patients with abnormal renal function determined at baseline with a blood test.
  7. Patients with a history of keloid formation.
  8. Patients with current skin infection.
  9. Patients on immunosuppressants.
  10. Any cognitive disorders where the patient would not be able to complete subject assessment questionnaires.
  11. 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)
  12. Patients requiring chronic use of any headgear (e.g., CPAP) that would interfere with the ability to wear post-operative ear protection.
  13. Pregnant females (a negative pregnancy test is required for females with reproductive potential)
  14. Female patients who are nursing/lactating
  15. 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:

  16. Treacher-Collins Syndrome
  17. Nager Syndrome
  18. Goldenhar syndrome or hemifacial microsomia plus an occlusal cant of 20 degrees or greater
  19. Absence of vertical ramus (as diagnosed on physical exam or CT)
  20. Absence of zygoma (as diagnosed on physical exam or CT)
  21. Significant orbital asymmetry or micro-ophthalmia (as diagnosed on physical exam or CT)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04399239
Other Study ID Numbers  ICMJE 3DBio12A2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party 3DBio Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE 3DBio Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account 3DBio Therapeutics
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP