Woman born with microtia receives first-ever 3D printed ear transplant from her own cells

In an unprecedented example of interdisciplinary achievement, a US startup, 3DBio Therapeutics, carried out the first-ever 3D printed ear transplant in a first-of-a-kind clinical trial. The patient who underwent the transplantation was reportedly suffering from microtia, a condition wherein a person is born without an external ear and got an artificial ear made out of her own tissues. According to a report by Cornell Chronicle, Cornell University's publication house, the company which carried out the transplant is a Cornellian-founded startup and was established in 2014.

How does the 3D-printed ear work?

Explaining the working of the 3D-printed ear, 3DBio Therapeutics revealed that it is first prepared using the patient’s own auricular cells combined with collagen. The company has named the investigational product AuriNovo, which is a patient-specific, biologic implant for use in surgical reconstruction of the external ear. As per the protocol for preparing the artificial ear, a surgeon first designs an AuriNovo implant which is customised according to the requirements, meaning the size and shape fit for the patient. 

During the microtia reconstruction surgery, the artificial or overshell components are placed around the patient's ears following which the surgeon will stitch the overshell together and implant the entire AuriNovo under the skin.

Interestingly, the 3D-printed product has been designed to regenerate cartilage tissue which eventually grows as if it is natural.  

"Not only is this an application you’ve never seen before, it’s made with a technology you’ve never seen before", Lawrence Bossnar, one of the co-founders of 3DBio Therapeutics said as per Cornell Chronicle. "Even tissue-engineered implants in general, there just aren’t that many of them on the market, or even in clinical trials". The developers of the implant believe that this breakthrough has the potential to improve the lives of thousands of children who are born with congenital ear deformities. 

While the clinical program was conducted under the US Food and Drug Administration (FDA), the AuriNovo product has not been approved by the FDA. "It is anticipated that it will take approximately 18 to 21 months to recruit the targeted number of subjects due to staged (spread out over time) enrollment and up to 5 additional years to complete the long-term follow up", 3DBio Therapeutics says.