Suspended

AUR-201AUR-201 Implant for Unilateral Microtia

Study Aim

This study aims to assess the safety, tolerability, and effectiveness of the AUR-201 implant in improving the appearance of the ear in individuals with unilateral microtia over a period of 24 weeks.

What is being tested

AUR-201

Combination Product

Who is being recruted

Congenital Abnormalities+2

+ Ear Diseases

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

From 8 to 29 Years

+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: January 2024

See protocol details

Summary

Principal SponsorAuregen Biotherapeutics, SA

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 26, 2024

Actual date on which the first participant was enrolled.

This study is focused on testing a new treatment for individuals with one-sided microtia, a condition where a person is born with an underdeveloped ear. The researchers are examining a new implant called AUR-201, which is made using 3D technology and a special gel-like substance containing cells from the patient's own ear. This study is important because it could offer a new way to help people with microtia, potentially improving their ear appearance and function using personalized medical technology. In this study, participants receive the AUR-201 implant under their skin. The process uses cells taken from the patient's ear, which are then combined with a biopolymer, a material that supports the cells. The study is designed to evaluate how safe and tolerable this treatment is, as well as its effectiveness in creating a more natural-looking ear. As this is an early-phase clinical trial, researchers are primarily focused on ensuring the treatment is safe and noting any side effects that occur, while also observing changes in the ear’s appearance after the implant.

Official TitleA Phase 1/2, Multi-Center, Open-Label, Single-Arm Safety, Tolerability, and Efficacy Study of an Auricle and Wedge Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia

NCT06072040

Principal SponsorAuregen Biotherapeutics, SA

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 29 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesEar DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOtorhinolaryngologic DiseasesCongenital Microtia

Criteria

16 inclusion criteria required to participate

* Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as some double barrier methods (condom with spermicide) in conjunction with use by the partner of an intrauterine device, diaphragm with spermicide, oral contraceptives, birth control patch or vaginal ring, or injectable or implanted contraceptives. Abstinence is acceptable only as true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. A woman that is postmenopausal (≥2 years since last menstrual period) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) is not considered a WCBP.

Naïve to microtia surgery or have had prior failed microtia surgery not involving the TPF flap;

Willing to refrain from non-contact sports and contact sports (e.g., football, soccer, rugby, boxing, karate) for 6 and 12 weeks, respectively, following the first implantation surgery, or longer if deemed necessary for healing by the PI. If the PI opts to implant the AUR-201 wedge at a separate subcutaneous location on Day 0 and then 12 weeks ± 28 days later implants the wedge in the final location, these periods of refraining from non-contact and contact sports will also apply to the second implantation surgery;

Able and willing to adhere to the post-operative wound care instructions (including, but not limited to, wearing protective devices specified by the PI) and the protocol specified follow-up schedule;

Show More Criteria

19 exclusion criteria prevent from participating

Known hypersensitivity to amide-containing anesthetics;

Treatment with a chemotherapeutic within 12 months prior to screening;

Additional planned surgical procedures, including piercings, at the microtia or biopsy sites (i.e., beyond the AUR-201 biopsy and implantation procedures with skin grafts) during the subject's planned participation in this study;

Treatment with oral steroids within 1 month prior to screening;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

AUR-201

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Romo Plastic Surgery

New York, United StatesOpen Romo Plastic Surgery in Google Maps

SuspendedOne Study Center