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

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

Study Description
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Brief Summary:
Long-term follow-up of unilateral microtia patients implanted with AUR-201.

Condition or disease Intervention/treatment Phase
Microtia Combination Product: AUR-201 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: eyes are blacked out in photos
Primary Purpose: Treatment
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)
Actual Study Start Date : January 26, 2024
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: AUR-201
AUR-201
 Combination Product: AUR-201
Auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06078566


Contacts
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Contact: Michelle Nelken 6177554149 mnelken@auregen.bio

Locations
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United States, New York
Romo Plastic Surgery Recruiting
New York, New York, United States, 10021
Contact: Thomas Romo, III, MD, FACS         
Principal Investigator: Thomas Romo, III, MD, FACS         
Sponsors and Collaborators
Auregen Biotherapeutics, SA
Investigators
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Principal Investigator: Thomas Romo, III, MD, FACS Romo Plastic Surgery
More Information
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Responsible Party: Auregen Biotherapeutics, SA
ClinicalTrials.gov Identifier: NCT06078566    
Other Study ID Numbers: AUR-201-06
First Posted: October 12, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Microtia
Ear Diseases
Otorhinolaryngologic Diseases
Congenital Abnormalities