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Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201

NCT06078566 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-11-21

No results posted yet for this study

Summary

Long-term follow-up of unilateral microtia patients implanted with AUR-201.

Conditions

  • Microtia

Interventions

COMBINATION_PRODUCT

AUR-201

Auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.

Sponsors & Collaborators

  • Auregen Biotherapeutics, SA

    lead INDUSTRY

Principal Investigators

  • Thomas Romo, III, MD, FACS · Romo Plastic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2025-11-14
Completion
2025-11-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078566 on ClinicalTrials.gov