Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia

NCT06072040 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: AUR-201-05
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.

Conditions

Microtia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 weeks

Study Arms (1)

AUR-201

EXPERIMENTAL

AUR-201

Combination Product: AUR-201

Interventions

AUR-201 COMBINATION_PRODUCT

Auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.

AUR-201

Eligibility Criteria

• Age: 8 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Auregen Biotherapeutics, SA: lead

Study Sites (1)

Romo Plastic Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Romo, III, MD, FACS

  Romo Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: January 26, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)