In a first for medicine, a surgeon has successfully implanted an outer ear developed and 3D-printed in a laboratory.
A 20-year-old woman who was born with the congenital disorder microtia and had one misshapen ear received the new appendage in March, 3DBio Therapeutics, the company that manufactured the ear, said in a news release Thursday. The ear was constructed from her own cells as a mirror replica of her other ear.
Outside experts said it is the first time that 3D-printed tissue had been implanted into a human body.
“It’s a big milestone,” said Dr. Anthony Atala, the director of the Wake Forest Institute for Regenerative Medicine. “Ears have been implanted by hand. It’s now using a printer, which helps automate the process, which is important for the field.”
The milestone could open doors for investment and new excitement around 3D tissue printing, potentially paving the way for new therapies in regenerative medicine.
“I’m hoping these kinds of success will build enthusiasm and understanding this is moving from the realm of science fiction into reality,” said Adam Feinberg, a professor of biomedical engineering at Carnegie Mellon University and chief technology officer for Fluidform, a 3D bioprinting startup.
Microtia patients are born without outer ears or with appendages that are smaller and different in shape.
“A lot of these children experience psychological and social impacts from growing up without an outer ear,” said Dan Cohen, a co-founder and the CEO of 3DBio Therapeutics.
For microtia patients today, surgeons often carve into a child’s rib cage to shave off cartilage and then construct an ear.
3D printing, in which a machine creates a three-dimensional object from raw materials, could reduce risks. The process is also used to create houses to recycled tools on the International Space Station.
To print an ear, 3DBio Therapeutics scientists first built a three-dimensional computer model, based on a scan of the woman’s other ear. Then, they cultured living cells and put them into a “bioink” made of collagen. A printer then deposited the bioink layer after layer to create the right shape — a mirror image of the woman’s ear. A final biodegradable shell shields the implant while it generates cartilage.
“In this case, you don’t have to go into the rib cage and expose the lungs to infection and have other surgical risks,” said Adetola Adesida, a professor in the department of surgery at the University of Alberta, who was not involved in the implant.
Implanting a printed ear is much the same procedure as typical, Cohen said. Dr. Arturo Bonilla, a San Antonio-based pediatric ear reconstructive surgeon specializing in microtia, performed the March surgery.
In a news release, Bonilla said he hoped 3D printing would become the new standard of care for microtia patients.
The implant was part of an ongoing clinical trial involving 11 patients.
The company said it will share its clinical safety and efficacy data upon the trial’s completion. Without clinical trial data, the outside experts could not evaluate the methods used to construct the ear in detail. The outside experts who spoke with NBC News said the research appeared to be credible.
Feinberg said getting a green light from Food and Drug Administration regulators to pursue the research signals that the company has a reliable process.
The development of the ear could pave the way for more ambitious projects, Feinberg said.
“The ear is a relatively simple organ. It has some function. It does help funnel sound into the air,” Feinberg said. “We’re thinking of it mostly as a cosmetic outcome. The next step is to build more functional tissues or organs. It’s a much higher bar.”
3D printing technology could also help scientists scale regenerative medicine solutions that have been produced in laboratories but are not available broadly.
“3D printing is a really great tool to be able to automate the process,” Atala said. “It brings automation, reproducibility. It brings reliability. It brings decreased cost.”