Doctors Transplant 3-D Printed Ear Made of Human Cells

Three-dimensional printing has been utilized for the first time to create a body component using a patient’s own cells by the Queen’s biotech business 3DBio Therapeutic.

The manufacturer said on Thursday that a 20-year-old woman born with a tiny and malformed right ear had a 3-D printed ear implant manufactured from her own cells. In the first clinical trial of this technology’s successful medical application, the transplant was hailed by independent specialists as a spectacular advance in tissue engineering.

According to 3DBio Therapeutics, a Queens-based regenerative medicine business, the new ear was created to match the woman’s left ear exactly. An ear graft that was successfully implanted in March will continue to develop cartilage tissue, according to the firm that implanted it.

According to Carnegie Mellon University biomedical engineering and materials science and engineering professor Adam Feinberg, “It’s obviously a major thing.” One of the co-founders of FluidForm, which also uses 3-D printing for regenerative medicine, is Dr. Feinberg. As a result, he asserted, “this technology is no longer an “if,” but a “when.”

In a press release, 3DBio announced the results of the woman’s reconstructive surgery. Because of concerns over private information, the corporation has chosen not to make the technical details of the process available to the public, making it more difficult for independent experts to assess. The results will be published in a medical publication when the study is complete, the company said, citing a review by federal regulators of the trial design.

It’s possible that the transplants will fail or cause unexpected health problems for the 11 patients participating in the clinical experiment. However, doctors and industry officials say that the replacement ear is unlikely to be rejected by the patient’s body because the cells came from the patient.

Since 3DBio’s seven-year journey began, there have been a number of significant advancements in the field of organ and tissue transplantation. For the first time, a genetically engineered pig’s heart was transplanted into a 57-year-old man with coronary heart disease in Maryland in early January. Scientists are also working on ways to extend the lives of donated organs so that they do not go to waste; Swiss doctors revealed this week that a patient who received a human liver that had been preserved for three days was still healthy one year after receiving the organ..

An official with the genetically modified pig manufacturer United Therapeutics Corp. said that the company is now testing 3-D printing as a means of producing organs such as lungs for use in transplantation procedures. An Israeli institute of technology team also revealed in September that they had 3-D printed a network of blood vessels that would be necessary to provide nutrients to implanted tissue.

Prosthetic limbs consisting of lightweight metals and plastic have already been manufactured using 3-D printing technology. The ear implant, however, appears to be the first known example of a 3-D printed implant manufactured from living tissues and was made from a tiny glob of cells extracted from the woman’s deformed ear.

His auricle, or the exterior part of the ear, was small and deformed as a result of microtia, a very uncommon birth condition (it also can affect hearing in the ear). Researchers believe that the technology might be utilized to manufacture a wide range of replacement body parts ranging from spinal discs to the nose to knee meniscuses and even lumpectomies’ reconstructive tissue. Three-dimensional printing, they predicted, may one day generate organs as complicated as livers, kidneys, and pancreases.

Dr. Arturo Bonilla, a pediatric ear reconstructive surgeon in San Antonio, Texas, who performed the woman’s implant surgery, said, “This is so wonderful, sometimes I have to restrain myself a little bit.” Dr. Bonilla has no financial interest in 3DBio Therapeutics, which financed the study. “If everything goes according to plan, this will change the way this is done,” he said.

At Mount Sinai’s Icahn School of Medicine, James Iatridis is the director of a spine bioengineering laboratory and says that other 3-D printed tissue implants are in the pipeline, but that he has no knowledge of any other products that are currently being tested in clinical studies.

As a proof of concept, Dr. Iatridis added, “the 3-D ear implant will test biocompatibility, shape matching, and shape retention, in living persons”.

Still, Dr. Feinberg of Carnegie Mellon says that the exterior section of the ear is a rather basic appendage that is more aesthetic than useful. Solid organs, such as livers, kidneys, hearts, and lungs were still far off in the future, he said. If you’ve got an ear, you can make the leap to a spinal disc, he explained, but having an ear makes it more plausible.

A computer model is transformed into a three-dimensional physical object via the 3-D printing manufacturing process. Printing material in exact thin layers with a computer-controlled printer is the most common method.

3DBio Therapeutics’ innovative ear implant incorporates a number of proprietary technologies, including a way for transforming a small sample of a patient’s cells into billions of cells. Using a collagen-based “bio-ink,” the company’s 3-D printer maintains all components sterile during printing.

In a new, inconspicuous brick building in Queens outfitted with sterile “clean rooms” staffed by masked technicians in bunny suit coveralls, gloves, and bootees, all of the research and manufacturing takes place under one roof.

During a tour of 3DBio’s laboratory, CEO and co-founder Daniel Cohen stated, “It comes in as a biopsy from the patient, and it leaves a living ear.”

Patients who received new ears as part of the Dr. Bonilla clinical trial were among those who were the first to be successfully transplanted. Additionally, Cedars-Sinai Medical Center in Los Angeles is accepting trial participants.)

A sliver of cartilage from the woman’s microtia ear remnant was the first thing the physician removed during the procedure. Then he shipped it from San Antonio to the 3DBio building in Long Island City, Queens, along with a 3-D scan of her healthy ear.

The patient’s chondrocytes—the cells that makeup cartilage—were separated from the tissue sample and cultured in a customized slurry of nutrients at the laboratory, where they proliferated into billions of cells.

As explained by 3DBio’s chief scientific officer Nathaniel Bachrach, the living cells were then combined with the company’s collagen-based bio-ink.

It was necessary to use an advanced 3-D bio-printer to deliver the collagen through a thin, constant stream, which was then used to produce an exact reproduction of the patient’s normal, healthy ear using a syringe. Less than 10 minutes were required for the printing process to be completed.

Dr. Bonilla received the biodegradable shell-encased printed ear overnight in cold storage. It was then inserted right above the patient’s jawbone under her skin. The shape of an ear emerged once the skin around the implant was tightened.

Every year in the United States, about 1,500 newborns suffer from the disorder known as anotia in which the external ear is completely gone. To date, 11 volunteers ranging in age from 6 to 25 have participated in the clinical experiment, which will be monitored for the next five years to assess long-term safety and aesthetic results.

Dr. Bonilla noted that another alternative for microtia reconstruction is to harvest cartilage from the patient’s ribs and carve it into an approximate shape of the ear, which is generally done while the youngsters are young so that they are not subjected to bullying or mockery when they begin school.

New procedures can be completed in just a few hours, and they don’t necessitate a hospital stay. According to a spokesperson for 3DBio, the implant pricing is expected to be in line with the existing standard of care.

In Dr. Bonilla’s view, “the whole microtia world has been waiting for a technology where we wouldn’t have to go into the chest, and patients would heal from one day to the next,” he stated.

Even though it was still bandaged, Alexa, the patient who requested to only be named by her first name due to privacy concerns, expressed her excitement about her new ear. It’s not uncommon for kids who have microtia to be mocked, but Alexa says she wasn’t disturbed by it until her adolescent years when she started to feel more self-conscious about her looks.

“You care more about your image as a teenager,” she remarked. There were certain comments made by others that made me uncomfortable.

If you look closely enough, you won’t notice that Alexa has a deformed right ear because she wears her hair long and loose. As for her hair, she says she’s looking forward to putting it back up in pigtails or a bun and playing with it for a while.

A few years down the road, she believes her self-esteem will improve.