MicrotiaPhase 1/2NCT04399239
AuriNovo for Auricular Reconstruction
A Phase 1/2 study testing AuriNovo in people with Microtia, run by 3DBio Therapeutics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Microtia
- What is being tested?
- AuriNovo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Aug 2021to 18 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Reinisch, MD
Beverly Hills, California, 90211
Microtia-Congenital Ear Deformity Institute
San Antonio, Texas, 78240
About this study
Official title: 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
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
- Being tested
- AuriNovo
- Keywords
- ear reconstruction
- Medical subject headings
- Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriNovoCombination product
Also called AACC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: AuriNovo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety through assessment of AEs
Safety data will be collected on AE type, frequency and severity, treatment, and the time to resolution.
Measured: 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))
Measured: 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))
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start9 Aug 2021
- Primary completion18 May 2023
- Study completion18 May 2023
Why it stopped: Company decision, not safety related.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrotiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3DBio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399239
- Sponsor's protocol ID
- 3DBio12A2020
- Status last verified
- May 2023
- First submitted
- 19 May 2020
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04399239
- Acronym / sponsor ID
- 3DBio12A2020
- Conditions
- Microtia
- Keywords
- ear reconstruction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision, not safety related.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- 3DBio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AuriNovo | Experimental | Combination Product: AuriNovoAuriNovo 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. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuriNovoAlso: AACCAuriNovo 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 |
Primary outcome
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))
Results and safety
The study was stopped early (reason given: Company decision, not safety related.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AuriNovo in people with Microtia, run by 3DBio Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision, not safety related.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety through assessment of AEs (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.