Cure My Disease

Don't miss your cure!

 Log in / Sign up

Custom-grown ear implant tracked for long-term safety and looks

NCT ID NCT06078566

Disease control Sponsor: Auregen Biotherapeutics, SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed one person with microtia (a small or missing outer ear) who had already received an AUR-201 implant — a 3D-printed ear made from their own cartilage cells. Researchers checked how well the implant kept its shape and whether any side effects appeared up to 96 weeks after surgery. The study was terminated early, so the findings are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AUR-201 (a 3D-printed ear implant made from the patient's own cartilage cells)
What this could lead to
If successful, this could show that a custom-made, living ear implant remains stable and safe over time, offering a more natural option for people born with a small or missing ear.
What could go wrong
This is a very early, tiny study (only 1 participant) that was terminated early, so results are extremely limited. The implant may not hold its shape, could cause side effects, or may not work for others.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

1 person

The number who actually took part.

Started

Jan 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 29 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Microtia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

microtia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Microtia

Contacts and locations

Locations

  • Romo Plastic Surgery

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.