A US biotechnology company has announced that it’s managed to reconstruct an ear, using 3D-printing – of a sort.
The company, 3DBio, has developed an external ear implant from living tissue that can be used by people with microtia, a congenital condition where one or both outer ears are not fully developed, or not there at all. It is about to start a Phase 1/2A clinical trial with 11 participants, to establish its safety and initial efficacy.
One participant has already gone through the process, successfully having her ear reconstructed.
The implant, called the AuriNovo implant, is made from a 3D-printed scaffold, designed to match the patient’s other ear. The scaffold is composed of a hydrogel (a water-containing gel) filled with collagen, the most common protein in the human body. Cartilage cells from an individual patient are added to this scaffold.
Should patients wish to correct their microtia (not all do), the current way to do this is via plastic surgery that either harvests rib-cage material, or uses polyethylene plastic to re-create the ear.
Dr Arturo Bonilla, a paediatric ear reconstructive surgeon who led the first procedure, says the new implant method is less invasive than the rib-cartilage procedure, and more flexible than the plastic ear.
“My hope is that AuriNovo will one day become the standard of care, replacing the current surgical methods for ear reconstruction,” says Bonilla.
Dr Daniel Cohen, CEO and co-founder of 3DBio, says the method marks “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.
“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.”
Beyond ears, the company is next planning to investigate nasal reconstruction and spinal degeneration.
The researchers estimate that the interventions in the trial will be complete by February 2023, and the study will be complete by 2028.