Trials / Terminated
TerminatedNCT06072040
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
A Phase 1/2, Multi-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 / Phase 2
- Study type
- Interventional
- Enrollment
- 3 (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
- 2024-01-26
- Primary completion
- 2025-11-14
- Completion
- 2025-11-14
- First posted
- 2023-10-10
- Last updated
- 2025-11-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06072040. Inclusion in this directory is not an endorsement.