MicrotiaPhase 1/2AUR-201NCT06072040
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
A Phase 1/2 study testing AUR-201 in people with Microtia, run by Auregen Biotherapeutics, SA at 1 site in United States.
Trial summary
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age. Read more about this study
- Who is it for?
- Ages 8 to 29 years
- Conditions the study is for
- Microtia
- What is being tested?
- AUR-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 14 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child between 8 and 17 years of age (inclusive) at the time the parent/guardian signs the ICF or adult between 18 and 29 years of age (inclusive) at the time of signing the ICF. Note, the implantations of AUR-201 will initially be staggered based on age and completion of specified DSMB evaluations;
- Diagnosed with Grade II, III, or IV congenital unilateral microtia requiring complete auricular reconstruction;
- Naïve to microtia surgery or have had prior failed microtia surgery not involving the TPF flap;
- 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;
- 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;
- PI deems the subject an appropriate candidate for the planned AUR-201 biopsy and implantation procedure (i.e., either TPF flap or pocket technique) and that the subject meets the following criteria:
Show all 18Show fewer
- Healthy auricular cartilage donor site (e.g., conchal bowl site) on contralateral (non-microtic) ear available for biopsy;
- Healthy skin tissue at site of planned microtia repair;
- Healthy (other than for microtia) as determined by the PI based on medical history, physical examinations, body weight, vital signs, 12-lead electrocardiogram (ECG), and safety laboratory tests at screening/pre-biopsy baseline;
- Negative test results for human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum (i.e., syphilis), and West Nile virus 1 (WNV-1) within seven days prior to the biopsy for harvesting auricular cartilage from the contralateral ear;
- Body weight ≥ 30 kg at time of screening;
- Able to understand English or Spanish language;
- Subject or parent/guardian able to understand the ICF and give informed consent, and for subjects <18 years of age, subject able to understand the ICF and give assent;
- Subject or parent/guardian signed the ICFs for both this study (Protocol No. AUR-201-05) and the long-term follow-up (LTFU) study (Protocol No. AUR-201-06), and for subjects <18 years of age, the subject provided assent for both studies;
- Women of childbearing potential (WCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the pre-biopsy baseline visit;
- WCBP must agree to abstain from sex or use an adequate method of contraception* from the time of informed consent through the Final Study Visit (24 weeks ± 14 days after the first implantation surgery);
- Males must abstain from sex with WCBP or use an adequate method of contraception* from the time of informed consent through the Final Study Visit (24 weeks ± 14 days after the first implantation surgery).
- 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.
Who cannot join
- Any comorbidities likely to affect healing or the ability to adhere to the protocol, including:
- Burns, trauma, problematic wound healing, or scarring skin malformations at the planned site of microtia repair or the planned site of biopsy collection for auricular cartilage;
- Squamous cell carcinoma, basal cell carcinoma, or melanoma at the planned site of microtia repair or the planned site of biopsy collection for auricular cartilage;
- Uncontrolled diabetes or hypertension;
- History of diabetes requiring amputation or dialysis;
- Serious autoimmune disorder, or ongoing immunocompromised state;
Show all 39Show fewer
- Current or recent history (within four weeks prior to initial screening visit) of a clinically significant bacterial, fungal, or mycobacterial infection;
- Current clinically significant viral infection;
- History of human transmissible spongiform encephalopathies (TSEs), including Creutzfeldt-Jakob disease;
- History of Zika virus infection;
- Completed treatment of syphilis within 12 months prior to screening;
- Uncontrolled acne vulgaris in the planned site of microtia repair;
- History of organ transplant;
- Major cardiac, pulmonary, renal, hepatic, metabolic, neurologic, or urologic disorders;
- Predisposition or history of keloid or hypertrophic scar development;
- Lifestyle activities likely to affect healing or ability to adhere to the protocol [e.g., active contact sports and protective gear that interferes with wearing post-operative molds (e.g., silicone mold or protective gauze) and plastic ear cup];
- Diagnosed with any of the following syndromes or conditions:
- Treacher-Collins syndrome;
- Nager syndrome;
- Goldenhar syndrome or hemifacial microsomia plus an occlusal cant of 20 degrees or greater;
- Absence of vertical ramus [as diagnosed on physical exam or computed tomography (CT)];
- Absence of zygoma (as diagnosed on physical exam or CT);
- Significant orbital asymmetry or micro-ophthalmia (as diagnosed on physical exam or CT);
- History of major congenital disorder that could impact wound healing or cell expansion from the biopsy sample;
- Inadequate renal function as indicated by serum creatinine >1.5 x the upper limit of normal (ULN) and either a >50% decrement of blood flow or anatomic abnormalities on renal scan;
- Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study;
- Treatment with an immunosuppressant within 6 months prior to screening;
- Treatment with a chemotherapeutic within 12 months prior to screening;
- Treatment with isotretinoin within 12 months prior to screening;
- Treatment with oral steroids within 1 month prior to screening;
- Current tobacco, marijuana, or illicit drug use, including vaping;
- Participation in another interventional (non-observational) clinical study (other than as a documented placebo subject with no interventions at the planned site of biopsy or implantation) within 6 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;
- Pregnant or breastfeeding (or planning to become pregnant or breastfeed during the study);
- Presence of an implanted hearing enhancement device if it will interfere with the surgical technique (TPF flap or pocket) planned for AUR-201 implantation;
- Known hypersensitivity to the biopolymer components used in the manufacture of AUR-201, including gellan gum and sodium alginate;
- Known hypersensitivity to the components in the AUR-201 transport medium, including Dulbecco's Modified Eagle's Medium (DMEM), L-alanyl-L-glutamine, and 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES);
- Known hypersensitivity to amide-containing anesthetics;
- Known hypersensitivity to povidone iodine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 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
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
Read the detailed description
AUR-201 is an auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.
- Conditions
- Microtia
- Being tested
- AUR-201
- Medical subject headings
- Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR-201Combination product
Auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.
| Study group | Role | What they receive |
|---|---|---|
| AUR-201 | Experimental | AUR-201 Receives: Combination Product: AUR-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
- To assess the safety and tolerability of AUR-201 in patients with unilateral microtia based on Incidence of Treatment-Emergent Adverse Events from the time of biopsy sample collection of auricular cartilage from the contralateral (non-microtic) ear through 24 weeks post-implantation of AUR-201.
- The severity of AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: 24 weeks
Appearance/Efficacy of the AUR-201 Implant
- To assess the efficacy of AUR-201 in patients with unilateral microtia based on improvement in overall appearance at 24 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start26 Jan 2024
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrotiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auregen Biotherapeutics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Romo, III, MD, FACS, Principal investigator, Romo Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072040
- Sponsor's protocol ID
- AUR-201-05
- Acronym
- AUR-201
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT06072040
- Acronym / sponsor ID
- AUR-201 / AUR-201-05
- Conditions
- Microtia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Auregen Biotherapeutics, SAIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
Detailed description
AUR-201 is an auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUR-201 | Experimental | Combination Product: AUR-201AUR-201 |
Who may qualify
- Ages
- 8 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Child between 8 and 17 years of age (inclusive) at the time the parent/guardian signs the ICF or adult between 18 and 29 years of age (inclusive) at the time of signing the ICF. Note, the implantations of AUR-201 will initially be staggered based on age and completion of specified DSMB evaluations;
- Diagnosed with Grade II, III, or IV congenital unilateral microtia requiring complete auricular reconstruction;
- Naïve to microtia surgery or have had prior failed microtia surgery not involving the TPF flap;
- 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;
- 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;
Key exclusion criteria (39 listed)
- Any comorbidities likely to affect healing or the ability to adhere to the protocol, including:
- Predisposition or history of keloid or hypertrophic scar development;
- Lifestyle activities likely to affect healing or ability to adhere to the protocol [e.g., active contact sports and protective gear that interferes with wearing post-operative molds (e.g., silicone mold or protective gauze) and plastic ear cup];
- Diagnosed with any of the following syndromes or conditions:
- Inadequate renal function as indicated by serum creatinine >1.5 x the upper limit of normal (ULN) and either a >50% decrement of blood flow or anatomic abnormalities on renal scan;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUR-201Auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix. | Combination product | AUR-201 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 24 weeks
* To assess the safety and tolerability of AUR-201 in patients with unilateral microtia based on Incidence of Treatment-Emergent Adverse Events from the time of biopsy sample collection of auricular cartilage from the contralateral (non-microtic) ear through 24 weeks post-implantation of AUR-201. * The severity of AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Appearance/Efficacy of the AUR-201 Implant
Time frame: 24 weeks
- To assess the efficacy of AUR-201 in patients with unilateral microtia based on improvement in overall appearance at 24 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.
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Related trials for Microtia
Recruiting
Case Management for Microtia
Congenital Microtia
Not yet recruiting
Deep Learning for Flap Perfusion Detection
Congenital Microtia
RecruitingPhase 2
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
Microtia, Dysbiosis
Not yet recruiting
OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
Deafness Caused by High Grade Microtia or Ear Atresia
Recruiting
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Microtia, Congenital, Microtia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Romo, III, MD, FACS principal investigator
Romo Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AUR-201 in people with Microtia, run by Auregen Biotherapeutics, SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.