A medical team has announced a successful human ear tissue implant. What is unique and exciting about this is that the ear was made from the patient’s own cells, created in a 3D bioprinting machine. According to New York Times, the patient was a 20-year-old woman with a condition called microtia affecting her right ear. The new ear was printed in a shape that directly matched her left ear, providing a natural look. Microtia is a rare congenital condition that causes the outer ear to be underdeveloped or absent. It usually only affects only one ear but can affect both, with 1,500 babies every year in the US being born with it. Microtia can also cause hearing loss due to its effects on the ear canal or middle ear. While this may not be life-threatening, it can cause long-term mental health problems and mood disorders. Currently, there are two ways to reconstruct the ear for people with microtia: rib cartilage ear reconstruction and artificial implants. Unfortunately, these methods are limited as they are difficult to perform, and few surgeons have the training. 3DBio Therapeutics (3DBio), a regenerative medicine company, has teamed up with Microtia-Congenital Ear Deformity Institute and they are currently conducting a Phase 1 /2a clinical trial – these trials are used to evaluate the safety and efficacy of the implant. The trial consists of 11 patients and is still ongoing, so there should be slight caution. As it is in the early days, the company has not yet disclosed technical details of the procedure – however, federal regulators have reviewed the trial design and set very strict manufacturing standards. Once the study is complete, then the data will be published in a medical journal. Generally, in this procedure, a patient’s own chondrocytes (cells involved in growing cartilage) are obtained from their affected ear. The cells are grown using a specialized cell culture system and then mixed with a bio-ink. The bio-ink is then shaped by a 3D bioprinter into a living implant in the shape of the patient’s unaffected ear. This implant is surrounded by a biodegradable overshell that helps provide early structural support and is implanted into the patient. This overshell is resorbed by the body over time. The implant will then mature with time and would give a typical “look and feel” of an ear. This technology aims to avoid implant rejection. It could also be used in young children, maintain a natural look over a lifetime, avoid painful rib cartilage harvests, and could be constructed in an outpatient surgical procedure. The technology platform was purpose-built to meet the Federal Drug Administrations (FDA) therapeutic manufacturing requirements and has been granted Orphan Drug and Rare Pediatric Disease Designation. This procedure will hopefully be used to treat other people with rare conditions like microtia. The procedure was conducted by a team led by Arturo Bonilla who is a leading pediatric ear constructive surgeon who specializes in microtia. “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,” said Bonilla in a statement. “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. My hope is that AuriNovo™ will one day become the standard-of-care replacing the current surgical methods for ear reconstruction requiring the harvesting of rib cartilage or the use of porous polyethylene (PPE) implants.” Overall, this is pretty awesome technology. In the future, this technology and workflow may be used for traumatic injuries, congenital conditions, and tissue degeneration. Source
