June 2, 2022 – Doctors in the U.S. have successfully transplanted a 3D-printed ear implant that uses the patient’s cells.
The first “bioprinted living tissue implant” went to a 20-year-old woman, who was born with a small and misshapen ear. The implant was printed in a shape that matched her other ear and “will continue to regenerate cartilage tissue,” which will help it to look and feel like a natural ear, according to The New York Times.
3DBio Therapeutics, a regenerative medicine company based in New York City, is doing an early-stage clinical trial with patients who have microtia, a rare congenital disorder where one or both outer ears are absent or underdeveloped. The disorder affects about 1,500 babies born in the U.S. each year and typically has limited reconstruction options.
3DBio and the Microtia-Congenital Ear Deformity Institute, in Texas, did the human ear reconstruction using the AuriNovo implant, which received FDA designations for orphan drug and rare pediatric disease in 2019.
“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,” Arturo Bonilla, MD, a pediatric ear reconstructive surgeon specializing in microtia who performed the surgery, said in a statement.
The clinical trial is looking at how safe and effective the AuriNovo implant will be, with the goal of replacing current ear reconstruction surgeries that require doctors to use rib cartilage or certain implants.
“The AuriNovo implant requires a less invasive surgical procedure than the use of rib cartilage for reconstruction,” Bonilla said. “We also expect it to result in a more flexible ear than reconstruction with a PPE [porous polyethylene] implant.”
3DBio announced the results of the patient’s surgery in a news release on Thursday, which didn’t include technical details of the procedure because of privacy reasons. The company said the FDA has reviewed the clinical trial design and set strict manufacturing standards. The data is expected to be published in a medical journal when the study is complete.
The manufacturing process begins by taking a small sample of the patient’s ear to create billions of cartilage cells. The living cells are then mixed with the company’s collagen-based “bio ink,” which is safe for the body. The 3D bio-printer uses that ink to create an object based on a digital model that copies the patient’s healthy ear.
The ear implant procedure, which was done in March, marks one of several recent breakthroughs in organ and tissue transplants, the Times reported. Numerous companies across the world are developing implants that use 3D-printed technology to help patients with deformities and other health issues.
With more research, the technology could be used to make other body parts, including spinal disks, noses, knee cartilage, rotator cuffs, and reconstructive tissue for lumpectomy procedures, 3DBio said. In the more distant future, 3D printing could potentially create vital organs, such as livers, kidneys, and pancreases.
The clinical trial, which is also enrolling patients at Cedars-Sinai Medical Center in Los Angeles, has included 11 volunteers ages 6 to 25 so far. The patients will be followed for 5 years to evaluate long-term safety and satisfaction.