AuriNovo for Microtia

No longer recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: 3DBio Therapeutics

Must not be taking: Immunosuppressants, Aminoglycosides

Disqualifiers: Cochlear implant, Renal dysfunction, Keloids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AuriNovo, designed to help individuals born with microtia, a condition where the outer ear is underdeveloped. The goal is to determine if AuriNovo can safely and effectively aid in ear reconstruction. AuriNovo uses a 3D-printed scaffold made from the patient's own ear cartilage cells to reshape the ear. Ideal participants have microtia on one side, have not undergone ear surgery, and can adhere to post-surgery care. This study aims to refine the treatment process and assess how well the new ear structure holds up over time. As a Phase 1, Phase 2 trial, this research focuses on understanding how AuriNovo works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, you may not be eligible to participate.

What prior data suggests that AuriNovo is safe for microtic ear reconstruction?

In a previous study, AuriNovo helped rebuild ears in patients with microtia, a condition where the outer ear doesn't fully develop. This treatment uses a 3D-printed structure made from a special gel that includes the patient's own cartilage cells. Research has focused on understanding its safety for people.

Early results suggest that AuriNovo is generally well-tolerated. Since this study is in its early stages, it primarily collects safety information. The treatment has passed basic safety tests in the lab and is now being tried in people. So far, no major safety issues have been reported. However, because it is still early, more information is needed to confirm its safety for everyone. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for microtia?

Unlike traditional treatments for microtia, which often involve using rib cartilage or synthetic materials to reconstruct the ear, AuriNovo offers a cutting-edge approach by utilizing a 3D-bioprinted collagen hydrogel scaffold. This scaffold is infused with the patient’s own auricular cartilage cells, making it a biologically natural and patient-specific solution. Researchers are excited about AuriNovo because it precisely matches the size and shape of the patient’s other ear, potentially leading to more natural-looking results and reducing the risks associated with foreign materials or complex surgeries.

What evidence suggests that AuriNovo is effective for microtia reconstruction?

Research has shown that AuriNovo, the treatment under study in this trial, offers a promising new approach for rebuilding underdeveloped ears in individuals with microtia, a condition where the outer ear doesn't form properly. AuriNovo is a custom-made implant created from the patient's own ear cartilage cells, ensuring a natural fit and appearance. This method uses 3D printing technology to produce an ear that matches the size and shape of the person's other ear. Early results suggest that this approach can enhance both the appearance and function of the ear. While complete clinical data is still being gathered, the personalized design of AuriNovo is expected to yield better results compared to traditional reconstruction methods. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Healthy subjects with no history of cancer, problematic wound healing, or immune disorders

Adhering to the follow-up schedule and post-surgery care instructions is able to be done.

The text is saying that the person needs to have an audiology assessment to make sure they are still eligible to be a part of the study and that the study will not prevent them from getting hearing correction surgery in the future.

Exclusion Criteria

You have had a surgery to implant a hearing device in the past.

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 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical reconstruction of the external ear using the AuriNovo construct

3 months

Multiple visits for surgical procedure and post-surgical care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of AEs and satisfaction scores

3 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• AuriNovo

How Is the Trial Designed?

Group I: AuriNovo Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

3DBio Therapeutics

Lead Sponsor

Trials

1

Recruited

2+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04399239

NCT04399239 | AuriNovo for Auricular Reconstruction 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.

2. microtia.net microtia.net/the-future-of-microtia-surgery/

The Future of Microtia Surgery AuriNovo is a patient-specific, biologic implant for use in surgical reconstruction of the external ear (auricle) in people born with microtia Grades II-IV.

3. biospace.com biospace.com/3dbio-therapeutics-and-the-microtia-congenital-ear-deformity-institute-conduct-human-ear-reconstruction-using-3d-bioprinted-living-tissue-implant-in-a-first-in-human-clinical-trial

3DBio Therapeutics and the Microtia-Congenital Ear ... The clinical trial will collect safety data on microtic ear reconstruction using AuriNovo™ and assess preliminary efficacy data which will ...

4. mms.businesswire.com mms.businesswire.com/media/20220602005051/en/1473688/1/3DBio_AuriNovo.pdf

AuriNovo™ 3D-Bioprinted Ear Implant: A First-of-its-kind ... The study will collect safety data, efficacy (aesthetic outcome) data, and evaluate technical, logistical, surgical and post-surgical care ...

5. withpower.com withpower.com/trial/phase-2-congenital-microtia-7-2021-57e07

AuriNovo for Auricular Reconstruction · Info for Participants This trial is testing AuriNovo, a custom-made biological ear implant, for people born with underdeveloped ears (microtia Grades II-IV).

6. ir.printbio.com ir.printbio.com/3dbio-therapeutics-and-the-microtia-congenital-ear-deformity-institute-conduct-human-ear-reconstruction-using-3d-bioprinted-living-tissue-implant-in-a-first-in-human-clinical-trial/

Human Ear Reconstruction Using 3D-Bioprinted Living Tissue ... The clinical trial will collect safety data on microtic ear reconstruction using AuriNovo™ and assess preliminary efficacy data which will be ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9234983/

Bringing Hydrogel-Based Craniofacial Therapies to the Clinic Ultimately, 10 years later, the FDA removed the boxed warning after multiple post-market studies demonstrated no increased safety risk with use of the gel. 6.3.

8. 3dprintingindustry.com 3dprintingindustry.com/news/3dbio-conducts-successful-human-ear-reconstruction-with-3d-bioprinted-aurinovo-implant-210201/

3DBio conducts successful human ear reconstruction with ... The Phase 1/2a clinical trial is currently evaluating the safety and efficacy of the AuriNovo implant for use in reconstructive surgeries in ...

9. threedmedprint.biomedcentral.com threedmedprint.biomedcentral.com/articles/10.1186/s41205-025-00253-2

Assessing the landscape of clinical and observational trials ... The trial aimed to implant AuriNovo™, an auricle bioprinted using autologous chondrocytes in a collagen bioink and customized to the patient's ...