A 20-year-old woman who was born with a small and misshapen right ear has received a 3-D printed ear implant made from her own cells, the manufacturer announced on Thursday. Independent experts said that the transplant, part of the first clinical trial of a successful medical application of this technology, was a stunning advance in the field of tissue engineering.
The new ear was printed in a shape that precisely matched the woman’s left ear, according to 3DBio Therapeutics, a regenerative medicine company based in Queens. The new ear, transplanted in March, will continue to regenerate cartilage tissue, giving it the look and feel of a natural ear.
“It’s definitely a big deal,” said Adam Feinberg, a professor of biomedical engineering and materials science and engineering at Carnegie Mellon University. Dr. Feinberg, who is not affiliated with 3DBio, is a co-founder of Fluid Form, a regenerative medicine company that also uses 3-D printing. “It shows this technology is not an ‘if’ anymore, but a ‘when,’” he said.
Scientists have for the first time developed a 3D printed ear implant using living tissue under the first-in-human Phase 1/2a clinical trials in the United States.
3DBio Therapeutics (3DBio), a clinical-stage regenerative medicine company, announced the successful surgery of a rare congenital deformity where one or both outer ears are absent or underdeveloped.
The ear was printed in a shape that matched the woman's left ear and according to its makers, it will continue to regenerate cartilage tissue, making it feel natural. The company further said that the implant, being called Auriform, is designed to provide a treatment alternative to rib cartilage grafts and synthetic materials traditionally used to reconstruct the outer ear of microglia patients.
The team relied on 3D scanning of the opposite ear to specifically match the patient’s ear geometry. It incorporated the patient’s own auricular cartilage cells into a 3D-printed, living, full-sized ear construct designed to replace the patient’s microglia-affected ear.
The procedure was led by Dr Arturo Bonilla, a leading pediatric ear reconstructive surgeon specializing in microglia in Texas, who said that he is inspired by what this technology may mean for microglia 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 Auriform 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," Dr. Bonilla added.
While the company has not released the technical details of the procedure over proprietary concerns, it stated that it took over seven years to develop the technology.
“We believe that the microglia 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 microglia patients, but also demonstrate the potential for the technology to provide living tissue implants in other therapeutic areas in the future.” Daniel Cohen, Ph.D., 3DBio Chief Executive Officer, said in a release.
The company further added that the clinical trial will collect safety data on microglia ear reconstruction using Auriform and assess preliminary efficacy data.
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