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

Auregen Biotherapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Microtia

Treatments: Combination Product: AUR-201

Study type: Interventional

Funder types: Industry

Identifiers

NCT06078566

AUR-201-06

Details and patient eligibility

About

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

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 8 to 29 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

AUR-201

Experimental group

Description:

AUR-201

Treatment:

Combination Product: AUR-201