drugset / Trial / NCT04399239

AuriNovo for Auricular Reconstruction

NCT04399239 ↗

Phase 1/2 Terminated 2 enrolled 3DBio Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

AuriNovo provides a patient-specific, biological construct for use in the surgical reconstruction of the external ear in people born with microtia Grades II-IV. This Phase 1 / 2A study is being conducted to collect preliminary safety data on microtic ear reconstruction using AuriNovo, fine-tune technical, logistical, surgical, and post-surgical care aspects related to implantation, and to gather preliminary efficacy data including short- and longer-term in vivo duration and biological status of the implant.

Timeline

Start
2021-08-09
Primary completion
2023-05-18
Completion
2023-05-18

Outcome

Outcome not reported

Stopped: “Company decision, not safety related.”

Drugs

EvaluationDrugModalityDoseRoute
Subject AuriNovo Other / unclassified — Other

Indications