Trials / Terminated
TerminatedNCT06078566
Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
Long-Term Follow-Up Study of Unilateral Microtia Patients Who Participated in Study AUR 201 05 and Had the AUR-201 Implant in Place at Final Visit (24 Weeks After the First Implantation Surgery)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Auregen Biotherapeutics, SA · Industry
- Sex
- All
- Age
- 8 Years – 29 Years
- Healthy volunteers
- Not accepted
Summary
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
Detailed description
Long-term follow-up study of unilateral microtia patients who participated in Study AUR-201-05 and had the AUR-201 implant in place at the final visit (24 weeks post-implantation).
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
- 2023-10-12
- Last updated
- 2025-11-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06078566. Inclusion in this directory is not an endorsement.