AuriNovo for Microtia

Phase 1 & 2

Waitlist Available

Research Sponsored by 3DBio Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing AuriNovo, a custom-made biological ear implant, for people born with underdeveloped ears (microtia Grades II-IV). The study aims to ensure the safety of the implant and improve surgical techniques. The goal is to see how well the implant works and lasts. AuriNovo is developed using novel tissue engineering techniques, including a 3D-printed biodegradable auricle scaffold combined with patient-derived cells.

Eligible Conditions

Microtia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy as measured through overall satisfaction scores

Safety through assessment of AEs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AuriNovoExperimental Treatment1 Intervention

AuriNovo is a patient-specific, biologically natural, supportive base for surgical reconstruction of the external ear (auricle) in people born with microtia Grades II-IV. The construct is a 3D-bioprinted collagen hydrogel scaffold encapsulating the patient's own auricular cartilage cells (chondrocytes). The construct is printed in a size and shape that matches the contralateral ear for implantation into the patient.

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