AMS Spring 2023

Bioprinted Ear Transplants in Clinical Trials with 3DBio

6K SmarTech

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Affecting one to five of every 100,000 children born, Microtia is a condition in which an individual has an undeveloped ear or no external ear features at all. Treatment may consist of creating an ear prosthetic or surgical reconstruction via rib cartilage graft. This latter case involves several operations in which rib cartilage is formed into an ear shape, growing it in place on the scalp, and then raising the ear into place. 3DBio Therapeutics hopes that it has found an easier path with bioprinting.

3DBio is a very credible company that includes Cornell professors Larry Bonassar and Hod Lipson. The latter is one of the sharpest minds in 3D printing and has done a lot of groundbreaking work for many years. The company is running a human Phase 1/2a clinical trial with 11 patients to test the efficacy and safety its AuriNovo product. Designed to mirror the patients’ intact ear, the AuriNovo is a bioprinted collagen ear implant made out of a hydrogel and the patients’ own chondrocytes (cartilage generating cells). Conducted by Cedars-Sinai Pediatric Plastic Surgery, the Microtia-Congenital Ear Deformity Institute, and 3DBio, the clinical trial started in 2021 and is set to run at the earliest until 2023, with the study ending in 2028.

“As a physician who has treated thousands of children with microtia from across the country and around the world, I am inspired by what this technology may mean for microtia patients and their families. This study will allow us to investigate the safety and aesthetic properties of this new procedure for ear reconstruction using the patient’s own cartilage cells. My hope is that AuriNovo will one day become the standard-of-care replacing the current surgical methods for ear reconstruction requiring the harvesting of rib cartilage or the use of porous polyethylene (PPE) implants. The AuriNovo implant requires a less invasive surgical procedure than the use of rib cartilage for reconstruction. We also expect it to result in a more flexible ear than reconstruction with a PPE implant. The AuriNovo living tissue implant is designed to provide a better solution for patients born with microtia by transforming their appearance and building their confidence and self-esteem,” said Pedriatric Microtia surgeon Dr. Arturo Bonilla.

“This is a truly historic moment for patients with microtia, and more broadly, for the regenerative medicine field as we are beginning to demonstrate the real-world application of next-generation tissue engineering technology. It is the culmination of more than seven years of our company’s focused efforts to develop a uniquely differentiated technology platform meeting the FDA’s requirements for therapeutic manufacturing of reconstructive implants. We believe that the microtia clinical trial can provide us not only with robust evidence about the value of this innovative product and the positive impact it can have for microtia patients, but also demonstrate the potential for the technology to provide living tissue implants in other therapeutic areas in the future. Our initial indications focus on cartilage in the reconstructive and orthopedic fields including treating complex nasal defects and spinal degeneration. We look forward to leveraging our platform to solve other high impact, unmet medical needs like lumpectomy reconstruction and eventually expand to organs,” said 3DBio CEO Daniel Cohen.

We’ve been looking at various 3D printed ear stories over the years, like this reconstruction and this UK clinical trial. I would expect a lot of similar products to emerge, should funding be available. It’s tough to think of any other bioprinted implant that is lower risk. The company has been working on the implant for seven years and hopes to parlay success in this area to a similar product for nasal defects, lumpectomies, and, later still, orthopedic applications, such as rotator cuff injuries, torn meniscuses, and herniated disks. This is a huge step forward for an impressive firm in an admirable field.

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