In A First, Patient Receives 3-D Printed Ear Implant Made From Her Own Cells

3-D Printed Ear Implant: Alexa, 20, who was born with a small and contorted right ear, received the new ear printed in a shape that precisely matched her left ear.

A woman from Mexico recently received a 3-D printed ear implant made from her own cells. The ear was manufactured by 3D Bio Therapeutics, a regenerative medicine company based in Queens. | Representative Photo

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A woman from Mexico recently received a 3-D printed ear implant made from her own cells. This marks the first instance of a successful medical application of 3-D bioprinting using the patient’s own cells. Alexa, 20, who was born with a small and contorted right ear, received the new ear printed in a shape that precisely matched her left ear.

The ear was manufactured by 3D Bio Therapeutics, a regenerative medicine company based in Queens. The company announced on Thursday that the new ear, transplanted in March, will continue to regenerate cartilage tissue, giving it the look and feel of a natural ear, The New York Times (NYT) reported.

How The Transplant Is A ‘Stunning Advance’ In Tissue Engineering

According to independent experts, the transplant, which is part of the first clinical trial of a successful medical application of 3D bioprinting, was a stunning advance in the field of tissue engineering. Quoting Adam Feinberg, who co-founded FluidForm, another regenerative medicine firm that uses 3-D printing, the NYT report said that the transplant is definitely a "big deal", and that it shows the technology is not an 'if' anymore, but a 'when'. 

The company which manufactured the 3-D printed ear announced the results of Alexa's reconstructive surgery in a press release, but did not reveal the technical details of the procedure, citing proprietary concerns. However, the company stated that the trial design was reviewed by federal regulators, and that the data would be published in a medical journal after the study was complete.

As many as 11 patients are involved in the ongoing clinical trial. There is a possibility of the transplants failing or bringing unanticipated health complications. However, doctors and company officials clarified that the new ear is not likely to be rejected by the body because the cells originated from the patient's own tissue, according to the report.

The company's recent feat is one of several recent achievements in the pursuit to improve organ and tissue transplants. In January this year, surgeons in Maryland transplanted the heart of a genetically modified pig into a 57-year-old man with heart disease. However, the man died two months after the transplant. In order to ensure that the life of donor organs do not go to waste, scientists are developing techniques to extend the life of those organs. According to an article published in the journal Nature this week, a patient who received a human liver that had been preserved for three days was still healthy a year later. The transplant was performed by doctors at the University Hospital Zurich, Switzerland.

How Is The 3D Ear Different From Other Prosthetics?

Earlier, companies used 3-D printing technology to create custom-fit prosthetic limbs made of plastic and lightweight metals. However, the ear implant produced by 3D Bio Therapeutics is different because it was made from a tiny glob of cells harvested from the patient's contorted ear. Also, this is the first known example of a 3-D printed implant made of living tissues, the NYT report said.

What Do Company Executives And 3-D Bioprinting Experts Say?

Alexa was born with microtia, a rare birth defect that causes the auricle, which is the external part of the ear, to be small and malformed, and can affect hearing in the ear. The company executives said that with more research, the technology could be used to make many other replacement body parts, including spinal discs, noses, knee menisci, rotator cuffs and reconstructive tissue, according to the report. They added that 3-D printing could even produce far more complex vital organs such as livers, kidneys, and pancreases.

Quoting Dr Arturo Bonilla, a paediatric ear reconstructive surgeon based in San Antonio, Texas, who performed Alexa's implant surgery, the report said that if everything goes as planned, the transplant will revolutionise the way this is done.

Dr James Iatrids, who heads a spine bioengineering laboratory at Mount Sinai's Icahn School of Medicine, said the 3-D ear implant is a proof of concept to evaluate biocompatibility, and shape matching and shape retention in living people.

Dr Feinberg of Carnegie Mellon University, Pittsburgh, Pennsylvania, said that the external part of the ear is a relatively simple appendage that is more cosmetic than functional, and cautioned that the path toward solid organs including livers, kidneys, hearts, and lungs was still a long one, according to the report. 

How Was The 3-D Printed Ear Manufactured?

The 3-D printing manufacturing process creates a solid, three-dimensional object from a digital model, and involves the use of a computer-controlled printer that deposits material in thin layers to create the precise shape of the object. 

The ear implant created by 3DBio Therapeutics was manufactured through the integration of several proprietary technologies, beginning with a method which generates billions of cells from a small sample of a patient's cells, the company executives said. A collagen-based "bio ink" which is safe in the human body, and keeps all the materials sterile, was used in the 3-D bioprinting process. 

The 3-D printed ear was manufactured in hygienic conditions in "clean rooms" in a new building in Queens. Daniel Cohen, 3DBio's chief executive and co-founder, said, "It comes in as a biopsy from the patient, and it leaves a living ear." 

Dr Bonilla, who leads the clinical trials, began the surgery by removing half of a gram of cartilage from the woman's microtia ear remnant. Then, he shipped the cartilage, along with a 3-D scan of her healthy ear, from San Antonio to the 3DBio building in Long Island City, Queens, where the patient's chondrocytes were isolated from the tissue sample. Chondrocytes are cells responsible for cartilage formation. After being isolated, the cells were grown in a proprietary slurry of nutrients, in which they proliferated into billions of cells. 

Nathaniel Bachrach, 3DBio's chief scientific officer, explained that the living cells were then mixed with the firm's collagen-based bio ink, similar to chocolate chips being mixed into cookie dough ice cream.

Then, the collagen was inserted through a syringe into the specialised 3-D bioprinter, following which the material was squirted out from a nozzle in a steady, thin stream, zipping around to create a small oblong shape, the article said. The shape was a mirror replica of the patient's healthy ear, and it took less than ten minutes to print the ear. 

After this, the printed ear shape was encased in a protective biodegradable shell, and shipped to Dr Bonilla's lab, where the surgeon implanted the ear under the patient's skin, just above her jawbone. The shape of an ear emerged as the skin tightened around the implant. 

Are There Other Options For Microtia Reconstruction?

According to the report, Dr Bonilla said that another option for microtia reconstruction requires inpatient surgery to harvest cartilage from the patient's ribs. Then, the cartilage is carved into an approximate shape of the ear.

The new procedure is more efficient because it can be performed  in a few hours, and outside of a hospital. Dr Bonilla said he has always felt the whole microtia world has been waiting for a technology where doctors would not have to go into the chest, and the patients would heal from one day to the next.

According to the report, Alexa said that earlier, she used to cover her right ear by wearing her hair long and loose, but now, she is looking forward to having fun with her hair, and will put it back in pigtails or up in a bun. She said she believes her "self-esteem will go up".