Sunday, December 10, 2023

3DBio implants 3D-bioprinted ear in a first-in-human clinical trial

A Cornellian-founded startup company, 3DBio Therapeutics, has announced the successful implantation of a 3D-bioprinted ear implant grown from the patient’s own living cells in a first-of-its-kind clinical trial.

This bioengineered breakthrough has the potential to significantly improve the lives of children who are born with microtia, a congenital ear deformity, around the world. The current treatments for microtia often involve plastic implants or ear reconstructions made from a patient’s own cartilage, harvested from their ribs, but that’s a very invasive procedure.

Now, the 3D-bioprinting platform potentially offers patients an alternative solution with a living ear implant made from their own cells. The implant known as AuriNovo, developed by 3DBio Therapeutics, consists of an entire suite of technologies, processes, and engineering that supports 3D bioprinting.

First, chondrocytes – cells that form cartilage – are extracted from a patient’s impacted ear. These cells are expanded and grown in a specialized cell culture system and then mixed with a collagen-based bio-ink called ColVivo. That material is then 3D-bioprinted into a living ear implant that matches the size and shape of a typical ear. The end result is an AuriNovo implant that is surgically placed under the patient’s skin along with a temporary biodegradable shell that provides protection and structural support.

Now, the first patient has undergone the procedure as part of a phase 1/2a clinical trial, which aims to evaluate the safety and preliminary efficacy of the technology, specifically for patients with microtia. Conducted by 3DBio and Microtia-Congenital Ear, the trial involves 11 patients and is being conducted in sites in Los Angeles, California, and San Antonio, Texas.

The company hopes that the approach could eventually lead to tissue implants for treating other conditions and traumatic injuries, reconstructive and regenerative therapy, and possibly even the biomanufacture of whole organs.