Trials / Terminated
TerminatedNCT06225336
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia (Australia)
A Phase 1/2, Single-Center, Open-Label, Single-Arm Safety, Tolerability, and Efficacy Study of an Auricle and Wedge Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Auregen Biotherapeutics, SA · Industry
- Sex
- All
- Age
- 8 Years – 29 Years
- Healthy volunteers
- Not accepted
Summary
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
Detailed description
AUR-201 is an auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | AUR-201 | Auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix. |
Timeline
- Start date
- 2022-11-04
- Primary completion
- 2025-09-10
- Completion
- 2025-09-10
- First posted
- 2024-01-25
- Last updated
- 2025-11-19
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT06225336. Inclusion in this directory is not an endorsement.