A US-based regenerative medicine start-up 3DBio Therapeutics has successfully transplanted a 3D printed human ear made from a patient’s own living cells in a first-of-its-kind clinical trial.   

The bioprinted transplant IS carried out on a 20-year-old woman who was born with a mishappen ear. The groundbreaking technology has been developed for patients with microtia, a rare congenital deformity in which one or both outer ears are absent or underdeveloped.  

“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,” said Dr Arturo Bonilla, the surgeon who performed the procedure.  

An Alternate Solution To The Existing Procedures  

Microtia is a rare type of condition in which a child’s outer ear does not fully develop during the pregnancy. One in 5000 children is born with microtia every year. Before 3D printing came along, conventional solutions for microtia patients would involve taking cartilage from a person’s ribs, a very cumbersome operation or the use of porous polyethene (PPE) implants to reconstruct the outer ear.  

3DBio’s patient-specific implant, being called AuriNovo is developed using 3D bioprinting technology to provide a treatment alternative to conventionally procedures. This implant has the potential to significantly improve the lives of those children.   

This surgery is the first attempt in the world to 3D print cartilage from the patient’s own tissue. The ear is engineered in a shape that matched the woman’s other ear and will continue to regenerate cartilage tissue, making it look and feel like a natural ear.  

“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,” Bonilla added.   

3D Printing Living Tissue Implant  

The procedure of developing the implant begins with removing the cartilage from the patient’s affected ear and 3D scanning the patient’s unaffected ear in parallel to accurately match the implant’s geometry. The auricular cells are then extracted from the removed cartilage and expanded in specialized cell culture. These cells are then mixed with a collagen-based bio-ink, called ColVivo which is 3D bioprinted into a living tissue implant.   

The surgeon then placed the AuriNovo implant under the patient’s skin along with the artificial or overshell components for protection and structural support. Once the skin around the implant tightens, the shape of the ear becomes clearly visible. The implant has been designed to regenerate cartilage over patient’s lifetime and it’s less likely to be rejected because it is made from their own cells.  

“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 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,” said 3DBio CEO and Co-founder, Daniel Cohen.  

The clinical trial is currently evaluating the safety and efficacy of the AuriNovo implant. 3DBio intends to broaden the application of its proprietary 3D bioprinting technologies. This technology could eventually lead to tissue implants for other body parts like noses, knee cartilage etc. and vital organs such as livers, kidneys and pancreases.  

“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,” Cohen concluded.  

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