A 20-year-old woman born with a small, misshapen ear received a 3D printed ear implant made from her own cells—a first-of-its-kind procedure health experts have called "a stunning advance in the field of tissue engineering," Roni Caryn Rabin reports for the New York Times.
On Thursday, regenerative medicine company 3DBio Therapeutics announced that the patient, who is part of the first clinical trial with a successful medical application for this type of technology, became the first to benefit from what many experts have called "a stunning advance in the field of tissue engineering," Rabin writes.
For the new ear, the company used a 3D printing manufacturing process that forms a solid, three-dimensional object from a digital model. The technology uses a computer-controlled printer that deposits thin layers of material to form the precise shape of an object, Rabin writes.
According to 3DBio, the new ear implant used several proprietary technologies, including a method that turned a small sample of the patient's cells into billions of cells. The 3D printer uses a collagen-based "bio ink" that keeps all the materials sterile and is safe inside the body.
Before the procedure, Arturo Bonilla, the pediatric ear reconstructive surgeon who performed the woman's implant surgery, removed half of a gram of cartilage from the woman's microtia ear remnant, then shipped it, along with a 3D scan of her healthy ear, to the 3DBio lab.
At the lab, the patient's chondrocytes—cells that help form cartilage—were extracted from the patient's tissue sample and grown in a proprietary collection of nutrients that helped the small sample multiply into billions of cells.
Then, the living cells were combined with the company's collagen-based bio-ink, "like chocolate chips mixed into cookie dough ice cream," according to Nathaniel Bachrach, 3DBio's chief scientific officer.
This collagen mixture was then inserted into the specialized 3D bio-printer, which created a replica of the patient's healthy ear—a process that took less than 10 minutes.
"It comes in as a biopsy from the patient, and it leaves a living ear," explained Daniel Cohen, 3DBio's CEO and co-founder.
The printed ear shape was then sent to Bonilla in a protective biodegradable. In March, he implanted it under the patient's skin, right above her jawbone. Soon after, the skin tightened around the implant and the shape of an ear started to emerge, Rabin writes.
3DBio has not yet released the technical details of the procedure, citing proprietary concerns, but the company said that federal regulators reviewed the trial design and outlined strict manufacturing standards. Once the trial is complete, 3DBio said the data will be published in a medical journal. The ongoing clinical trial currently includes 11 patients.
It is possible that transplants could fail or result in unanticipated health complications. However, since the cells were generated from the patient's own tissue, doctors and company officials said the patient's new ear is not likely to be rejected by her body.
Companies have previously used 3D printing technology to produce prosthetic limbs, but this ear implant appears to be the first known example of a 3D printed implant made of living tissues. And while 3DBio says the technology could eventually be used to make many other replacement body parts, Adam Feinberg, aprofessor of biomedical engineering and materials science and engineering at Carnegie Mellon University, cautioned that the path toward solid organs is a long one.
Still, he acknowledged, "It's definitely a big deal."
Feinberg, who is not affiliated with 3DBio, is a co-founder of FluidForm, a regenerative medicine company that also uses 3D printing. "It shows this technology is not an 'if' anymore, but a 'when,'" he added.
According to 3DBio's news release, the woman's new ear will continue to regenerate cartilage tissue, giving it the look and feel of a natural ear.
Separately, James Iatridis, who leads a spine bioengineering laboratory at Mount Sinai's Icahn School of Medicine, noted that there are other printed tissue implants in development, but said he was unaware of any other products that have been tested in a clinical trial.
"The 3-D ear implant is then a proof of concept to evaluate biocompatibility, and shape matching and shape retention, in living people," Iatridis added.
"This is so exciting, sometimes I have to temper myself a little bit," Bonilla said. "If everything goes as planned, this will revolutionize the way this is done." (Rabin, New York Times, 6/2)
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