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

NCT06078566 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: AUR-201-06
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microtia

Outcome Measures

Primary Outcomes (2)

• Appearance/Long-Term Durability of the AUR-201 Implant

  \- The primary efficacy endpoint for the assessment of long-term durability is based on the improvement in overall appearance at 48 and 96 weeks post-implantation compared to pre-implantation baseline as determined by review and rating of photographs on a 5-point Likert scale by a panel of blinded independent experts.

  72 weeks. The study starts at 24 weeks post implantation and ends at 96 weeks post implantation for a total of 72 weeks for this study.

• Incidence of Long Term Treatment-Emergent Adverse Events

  * The primary safety endpoint for the assessment of long-term safety and tolerability is based on the incidence of treatment-emergent adverse events that initiate or worsen after the Final Study Visit of Study AUR-201-05 (24 weeks post-implantation) through the Final Study Visit of this LTFU study (96 weeks post-implantation). Any untoward medical occurrence that initiates or worsens after the Final Study Visit of Study AUR-201-05 through the Final Study Visit of this study (Study AUR-201-06), whether or not considered related to AUR-201 (including the associated procedures, i.e., biopsy, implantation, and explantation), will be included as part of this end. * The severity of AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  72 weeks. The study starts at 24 weeks post implantation and ends at 96 weeks post implantation for a total of 72 weeks for this study

Study Arms (1)

AUR-201

EXPERIMENTAL

AUR-201

Combination Product: AUR-201

Interventions

AUR-201 COMBINATION_PRODUCT

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

AUR-201

Eligibility Criteria

• Age: 8 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject or guardian signed the informed consent form (ICF).

You may not qualify if:

• \. Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study.

Sponsors & Collaborators

• Auregen Biotherapeutics, SA: lead

Study Sites (1)

Romo Plastic Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Romo, III, MD, FACS

  Romo Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: eyes are blacked out in photos
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 12, 2023
• Study Start: January 26, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)