A 20-year-old woman who was born with a small and misshapen right ear has received a 3-D printed ear implant made from her own cells. The transplant, part of the first clinical trial of a successful medical application of this technology, was said to be a stunning advance in the field of tissue engineering.
The new ear was printed in a shape that matched the woman's left ear. The company said that the new ear will look and feel like a natural ear.
Adam Feinberg is a professor of biomedical engineering and materials science and engineering at Carnegie Mellon University. Dr. Feinberg is a co-founder of FluidForm, a company that uses 3-D printing.
The results of the woman's surgery were announced in a news release. It is more difficult for outside experts to evaluate the process because the company has not publicly disclosed the technical details. The company said that federal regulators had reviewed the trial design and set strict manufacturing standards, and that the data would be published in a medical journal when the study was complete.
The clinical trial that includes 11 patients is still going on and it is possible that the transplants could fail or cause health problems. Doctors and company officials said that the new ear is not likely to be rejected by the body since the cells came from the patient's own tissue.
7 years in the making, 3DBio's success is one of several recent breakthrough in the quest to improve organ and tissue transplants. A genetically modified pig's heart was donated to a man with heart disease in Maryland in January. Swiss doctors reported this week that a patient who received a human liver that had been preserved for three days was still healthy a year later.
The company that provided the pig for the heart procedure is also experimenting with 3-D printing to make lungs for transplants. In September, scientists from the Israel Institute of Technology reported that they had printed a network of blood vessels.
Companies have used 3-D printing to make custom-fit limbs. The ear implant, made from a small amount of cells from a woman's ear, is the first example of a 3-D printed implant made of living tissues.
Microtia, a rare birth defect that causes the auricle, or external part of the ear, to be small and malformed, can affect hearing in the ear. The technology could be used to make many other replacement body parts, including spine discs, noses, knee menisci, rotator cuffs and reconstructive tissue for lumpectomies. They said that 3-D printing could produce more complex vital organs, like the kidneys and pancreases.
The doctor who performed the woman's implant surgery said that he sometimes has to temper himself. The trial was funded by 3Dbio, but Dr. Bonilla has no financial stake in the company.
James Iatridis, who heads a spine bioengineering laboratory at Mount Sinai's Icahn School of Medicine, said that other 3-D printed tissue implants were in the works, but that he was unaware of any other products being tested in a clinical trial.
The 3-D ear implant is a proof of concept to evaluate biocompatibility, and shape matching and shape retention in living people.
Dr. Feinberg said that the external part of the ear is more decorative than functional. He warned that the path to solid organs was still a long one.
3-D printing creates a three-dimensional object from a digital model. The technology uses a computer-controlled printer to create the exact shape of the object.
The new ear implant from 3DBio is the first to use a method for turning a small sample of a patient's cells into billions of cells. The company's 3-D printer uses abio ink that is safe in the body and keeps all of the materials sterile.
All of the research and manufacturing takes place under one roof, in a new, nondescript brick building in Queens, staffed by masked technicians wearing bunny suit coveralls, gloves and bootees.
Daniel Cohen, 3DBio's chief executive and co-founder, explained during a tour of the facility last week that it comes in as a biopsies from the patient.
The patient who received the new ear was one of the first to have had a successful transplant. Cedars-Sinai Medical Center in Los Angeles has trial volunteers.
The surgeon began by removing half of the woman's microtia ear remnant. He shipped that along with a 3-D scanned ear from San Antonio to the 3D Bio building in Long Island City, Queens.
The patient's cells were isolated from the tissue sample and grown into billions of cells at the facility.
The living cells were mixed with the company's bio-ink, which was similar to chocolate chip cookie dough ice cream, according to the chief scientific officer.
The 3-D bio-printer squirted out the material from a nozzle in a steady, thin stream to create a small oblong shape that was a mirror replica of the patient's healthy ear. The printing process took less than 10 minutes.
The printed ear shape was encased in a protective shell and shipped overnight to Dr. Bonilla. He put the ear under the patient's skin. The shape of an ear emerged when the skin around the implant was tightened.
Approximately 1,500 babies are born in the United States each year with microtia or a related condition, anotia, in which the entire external ear is missing. 11 volunteers, ages 6 to 25, have been included in the clinical trial so far, who will be followed for five years to evaluate long-term safety and aesthetic outcomes.
Microtia reconstruction can be done while the patient is young so they don't get bullied or ridiculed when they start school.
A new procedure can be done in a few hours. The pricing for the implant will be in line with the current standard of care, according to a spokeswoman for 3D Bio.
The world of microtia has been waiting for a technology that would allow patients to heal from one day to the next.
The patient, who asked to be identified only by her first name because of privacy concerns, said she was excited about the new ear even though it was still covered by a bandage. Though many children with microtia are teased by their peers, it can lead to anxiety, depression and hostility, which can be a problem when you become more self-conscious about your appearance.
She said that you care more for your image when you are a teenager.
Most people could not tell that she was missing an ear because she wore her hair long and loose. She said she is looking forward to having fun with her hair and putting it back in pigtails or a bun.
I think my self-esteem will go up, she said.
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