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Tissue Engineering

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

Study Summary

This trial is testing a new way to reconstruct the external ear for people born with microtia, a congenital deformity. They hope to collect safety data and preliminary efficacy data to see if this is a viable option for patients.

Eligible Conditions
  • Microtia

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as measured through overall satisfaction scores
Safety through assessment of AEs

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.

Find a Location

Who is running the clinical trial?

3DBio TherapeuticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities remaining to be a participant in this experiment?

"Based on the information provided by clinicaltrials.gov, this trial is no longer recruiting candidates as it was last updated in October of 2021. However, for those seeking to participate in a medical trial there are presently 7 other studies actively enrolling patients at the moment."

Answered by AI

What is the eligibility criteria for joining this medical experiment?

"This research investigation is seeking 11 qualified individuals afflicted with microtia, aged between 6 and 25 years old."

Answered by AI

Does the eligibility criteria for this trial encompass those who are over 30?

"Individuals wishing to partake in this medical research must fit within the age range of 6 to 25 years old. For those below 18 and above 65, there are 4 studies and 3 studies respectively."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
< 18
What site did they apply to?
Cedars-Sinai Pediatric Plastic Surgery
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I need help about 3d ear implant please help.
PatientReceived 1 prior treatment
~1 spots leftby Apr 2025