In an incredible week for medical advancements, filled with successful trials in the treatment of cancer, an astounding scientific feat has taken the internet by storm as a 20-year-old woman becomes the first person to receive a successful ear transplant using 3D-printed technology.
The patient in question was being treated for the congenital disorder microtia—a birth defect where the outer ear (or sometimes inner ear) does not develop—and received her new hearing organ in March 2022 by regenerative medicine company 3DBio Therapeutics, as revealed in a press release shared on 2 June. The transplanted ear, called AuriNovo, was developed from the patient’s own cells to act as an identical clone of her other ear and has been dubbed by some experts as the first time 3D-printed tissue has been successfully implanted into a human body.
3DBio Therapeutics, based in Long Island, New York, has also announced that the transplant is part of an ongoing clinical trial that will test the use of its AuriNovo ear on 11 patients, a huge step in tackling the issue of microtia that occurs in around 1,500 babies in the US each year, The Verge reported. Unfortunately, as of today, precise technical details about the process of growing the ear have not been disclosed by the company, with data only set to be released upon completion of the study, as noted by The New York Times.
However, the basic principle of the process, mentioned in both The New York Times and NBC News, involves the use of a 3D computer model that is based on a scan of the subject’s other ear. Once this has been built, living cells taken from the patient are cultured and placed into a “bioink” composed of collagen. A printer then places layer after layer of the bioink material to form the exact replica of the image of a patient’s other ear. Finally, the organ is shielded with a biodegradable shell until cartilage develops.
Doctor Daniel Cohen, chief executive officer and co-founder of the company, stated as part of the press release that “this is a truly historic moment for patients with microtia, and more broadly, for the regenerative medicine field as we are beginning to demonstrate the real-world application of next-generation tissue engineering technology.” Cohen further explained that the results were a culmination of seven years of development while continuously meeting the Food and Drug Administration’s (FDA) requirements for manufacturing the scientific components.
The transplant was carried out by microtia and ear reconstructive specialist surgeon Doctor Arturo Bonilla. “As a physician who has treated thousands of children with microtia from across the country and around the world, I am inspired by what this technology may mean for microtia patients and their families,” Bonilla said. The expert, who is also the founder and director of the Microtia-Congenital Ear Deformity Institute, added as part of the company’s press release that “this study will allow us to investigate the safety and aesthetic properties of this new procedure for ear reconstruction using the patient’s own cartilage cells.”
Aside from the aesthetics, Professor Anthony Atala, who was not involved with the study and is director of the Wake Forest Institute for Regenerative Medicine, told The Guardian that the newly grown and attached cartilage could actually help funnel sound into the inner ear. However, 3DBio Therapeutics may not be the first to achieve this as other similar cases have been previously reported in China.
Beyond this, Cohen has beliefs that such advancing waves in the technology in question (starting with the company’s reconstruction of cartilage in both nasal defects as well as more serious spinal degeneration) could eventually lead to the solving of even more medically complex issues that are often unmet—like breast reconstruction following cancer treatment which, over time, could extend to any organ. Though it’s of course imperfect, and ears are nothing compared to more ‘serious’ organs, the scientific advancement is most definitely a ground-breaking medical marvel.
Switzerland has voted for a new ‘presumed consent’ system on organ donations, which makes everyone a potential donor after their death—unless ‘opted out’ by the individual during their lifetime. The Federal Council and Parliament proposed the legal change on 15 May 2022, which was approved by over 60 per cent of voters with the aim to boost chances of patients on the waiting list and save more lives in the country.
According to the current laws in Switzerland, transplants are only possible if the deceased person had consented to it while alive. However, their wishes often remain unknown and, in such cases, the decision is usually left to the person’s family and relatives—who mostly opt against the donation. This system has left many waiting in vain for organ donors.
In fact, as per Swisstransplant, the Swiss National Foundation for organ donation and transplantation, one to two patients die every week while waiting for an organ donation in Switzerland. At the end of 2021, more than 1,400 patients were on the waiting list in the country of about 8.6 million people. Meanwhile, the foundation estimated that only 166 deceased individuals had donated their organs last year—with a total of 484 organs from deceased donors being transplanted to those in need.
In a press conference held at Bern, Franz Immer, director of Swisstransplant, admitted the voting result for the new system is a ‘yes to life’. “The public have shown that they are ready to give a chance to the people who are on the waiting list,” Immer added.
Under the ‘presumed consent’ model, people who do not wish to become organ donors after death must explicitly say so. Those who have not made their wishes clear would be assumed to be in favour. However, relatives would still be able to refuse if they know or suspect that the person concerned would have chosen not to donate an organ. In cases where no relatives can be contacted, no organs may be removed.
The rules of the system—which are already adopted in a number of other countries including Spain, Belgium, France, Austria and Wales—would only be applicable to those aged 16 and above. The medical conditions for donations also remain the same: only people who die in a hospital’s intensive care unit can donate their organs and two doctors must confirm the death.
Although Swiss Health Minister Alain Berset called the new move an “evolution,” not everyone agreed with the government’s proposals. According to France24, a group headed by a midwife and a doctor, with support from some theologians, jurists, populists and the religious right, has gathered enough signatures to force the issue to a referendum. “They claimed it was ethically dubious to assume that someone who has not made their wishes clear would consent to donate an organ,” the outlet wrote. “They insisted on the need for patients to provide explicit, informed consent before any and all medical procedures. They also warned that the shift would place greater strain on relatives of the deceased, who might not dare refuse, for fear that they would be viewed as selfish.”
At the same time, however, the Yes to the Transplantation Act committee highlighted how 80 per cent of the population supports organ donation. “An organ donation can save the lives of up to nine people and significantly improve their quality of life,” they outlined. “It is six times more likely that you or a family member could need a donor organ than that you could donate your organs.”
As of today, the Federal Office of Public Health (FOPH) predicts that the new presumed consent model will come into force in 2024 at the earliest.