A 20-year-old woman who was born with an imperfect right ear received an ear implant made from her own cells. Interestingly, these ear implants are made using 3D prints.
Independent experts say that the transplant, part of the first clinical trials of the successful medical application of this technology, represents a stunning advance in the field of tissue engineering.
3DBio Therapeutics, a regenerative medicine company based in New York, United States, said the new ear was molded in the exact same shape as the woman's left ear.
The new ear, which was transplanted in March, will continue to regenerate cartilage tissue and ultimately give the ear a natural look and feel.
The results of the woman's reconstructive surgery were announced by 3DBio in a news release. But so far, 3DBio has not publicly disclosed the technical details of the transplant process, making it difficult for outside experts to evaluate.
Quoted from The Irish Times, 3DBio 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 completed.
A clinical trial covering 11 patients is currently underway, and it is possible the transplant could fail or carry unforeseen health complications. But because the cells come from the patient's own tissue, the new ear is unlikely to be rejected by the body, doctors and company officials said.
The success of 3DBio, which spanned seven years, is one of several recent breakthroughs in efforts to improve organ and tissue transplantation.
In January, surgeons in Maryland transplanted a genetically modified pig heart into a 57-year-old man with heart disease. Unfortunately, this effort was only able to prolong his life for two months.
Scientists are also developing techniques to extend the life of donor organs so they don't go to waste. Swiss doctors reported this week that a patient who received a human liver that had been preserved for three days was found to be healthy a year later.
James Iatridis, who heads the spine biotechnology laboratory at Mount Sinai's Icahn School of Medicine, said another 3D-printed tissue implant was in the works, but he wasn't aware of any other products being tested in clinical trials.
"The 3D ear implant then became a proof of concept for evaluating biocompatibility, and shape matching and shape retention, in living people," Iatridis said.
According to him, the outer ear is a relatively simple appendage that is more cosmetic than functional. He warned that the road to implant solid organs such as liver, kidney, heart and lungs is still long.
The manufacturing process of 3D printing creates solid three-dimensional objects from digital models. This technology generally involves a computer-controlled printer that deposits the material in a thin layer to create the exact shape of the object.
The new ear implant from 3DBio Therapeutics integrates several proprietary technologies, executives say, starting with a method to turn a small sample of a patient's cells into billions of cells. The company's 3D printers use collagen-based "bio inks" that are safe in the body and keep all materials sterile.
Ear making
The surgeon started by removing half a gram of cartilage from the woman's remaining ear microtia. He sent that, along with a 3D scan of his healthy ear, from San Antonio to the 3DBio building in Long Island City, Queens.
At the facility, patient chondrocytes, cells responsible for cartilage formation, isolated from tissue samples and grown in a nutrient slurry, proliferate into billions of cells.
The live cells are then mixed with the company's collagen-based bio ink. Next, the collagen is fed through a syringe into a special 3D bio-printer, which sprays the material from a nozzle in a steady, thin stream, swirling it to create a tiny oval shape that is a replica of the patient's healthy ear. The whole printing process takes less than 10 minutes.
The molded ear shape is then encased in a biodegradable protective shell and kept in cold storage. Once finished, the ear is implanted under the patient's skin, just above the jawbone. When the skin around the implant is tightened, the shape of the ear will appear.