Trials / Terminated
TerminatedNCT04399239
AuriNovo for Auricular Reconstruction
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- 3DBio Therapeutics · Industry
- Sex
- All
- Age
- 6 Years – 25 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-08-09
- Primary completion
- 2023-05-18
- Completion
- 2023-05-18
- First posted
- 2020-05-22
- Last updated
- 2024-03-04
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04399239. Inclusion in this directory is not an endorsement.