Surgeons Transplanted a Lab-Grown Ear From Patient's Own Cells in Early Clinical Trial

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A medical team in the United States said on Thursday that they had successfully repaired a human ear using the patient's own tissue to build a 3D bioimplant, a groundbreaking method that they hope can one day be used to cure others with a rare birth condition.

The operation was part of an early-stage clinical experiment to assess the implant's safety and efficacy in persons with microtia, a condition in which the external ear is tiny and poorly shaped.

The implant, known as AuriNovo, was created by 3DBio Therapeutics, and the procedure was performed by Arturo Bonilla, founder and director of the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas.

"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," Bonilla stated.

He hopes the implant may one day replace the existing therapy for microtia, which requires transplanting cartilage from a patient's ribs or reconstructing the outer ears with synthetic materials such as porous polyethylene (PPE).

The method entails creating a blueprint by 3D scanning the patient's opposite ear, then extracting a sample of the patient's ear cartilage cells and growing them to an appropriate number.

These cells are combined with bio-ink made of collagen and molded into an outer ear. The implant is encased in a printed, biodegradable shell that provides immediate support but eventually dissolves in the patient's body.

The implanted ear is expected to grow over time, taking on the natural appearance and feel of a normal ear, including flexibility.

The clinical research, which is being done in California and Texas, is expected to enroll 11 participants.

According to Bonilla: "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."

Microtia affects around one out of every 2,000-10,000 newborns, according to the Centers for Disease Control and Prevention. Diabetic moms and a maternal diet deficient in carbs and folic acid are two factors that might increase risk.

Boys are more likely than girls to be afflicted, and Hispanic, Asian, Pacific Islander, and Native Americans are more affected than non-Hispanic Whites.

Children with microtia can develop normally and enjoy healthy lives in the absence of additional disorders, however they may struggle with self-esteem and face taunting and bullying because of their appearance.

3DBio plans to produce implants with more severe kinds of microtia in the future.

Other cartilage-related diseases that potentially benefit from 3D printed implants include nose abnormalities or injuries, breast reconstruction, knee meniscus injury, and shoulder rotator cuff tears.

"Our initial indications focus on cartilage in the reconstructive and orthopedic fields, and then our pipeline builds upon this progress to expand into the neurosurgical and organ system fields," the business states on its website.