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Tissue Engineering
AuriNovo for Auricular Reconstruction
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
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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Who is running the clinical trial?
3DBio TherapeuticsLead Sponsor