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

• ClinicalTrials.gov Identifier: NCT06078566
• Recruitment Status: Recruiting
• First Posted: October 12, 2023
• Last Update Posted: February 2, 2024
• Sponsor: Auregen Biotherapeutics, SA
• Information provided by (Responsible Party): Auregen Biotherapeutics, SA

Tracking Information

• First Submitted Date: September 29, 2023
• First Posted Date: October 12, 2023
• Last Update Posted Date: February 2, 2024
• Actual Study Start Date: January 26, 2024
• Estimated Primary Completion Date: June 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 11, 2023)

• Appearance/Long-Term Durability of the AUR-201 Implant [ Time Frame: 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. ]
  - 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.
• Incidence of Long Term Treatment-Emergent Adverse Events [ Time Frame: 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 ]
  • 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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
• Official Title: 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)
• Brief 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).
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:

eyes are blacked out in photos

Primary Purpose: Treatment

• Condition: Microtia

Intervention

Combination Product: AUR-201

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

Study Arms

Experimental: AUR-201

AUR-201

Intervention: Combination Product: AUR-201

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 9, 2023): 10
• Original Enrollment: Not Provided
• Estimated Study Completion Date: June 2026
• Estimated Primary Completion Date: June 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Participated in Study AUR-201-05 and had the AUR-201 implant (auricle* or auricle and wedge) in place at the Final Study Visit of Study AUR-201-05 (24 weeks after the first implantation surgery). *If the Principal Investigator (PI) opted not to implant the wedge component beneath the auricle component and the subject has only the auricle in place at the Final Study Visit of Study AUR-201-05, the subject will be considered eligible under this inclusion criterion;
2. Subject or guardian signed the informed consent form (ICF).

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 29 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Michelle Nelken; 6177554149; mnelken@auregen.bio

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06078566
• Other Study ID Numbers: AUR-201-06
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Auregen Biotherapeutics, SA
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Auregen Biotherapeutics, SA
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Principal Investigator: Thomas Romo, III, MD, FACS; Romo Plastic Surgery

• PRS Account: Auregen Biotherapeutics, SA
• Verification Date: February 2024