In the United States, a surgeon has transplanted an ear implant made from human cells! The company 3DBio Therapeutics was responsible for the manufacturing of this implant for a 20-year-old young woman. She suffered from microtia in her right ear, a congenital anomaly that prevents the development of the external ear. Named AuriNovo, the ear transplant was 3D printed from the patient’s own collagen hydrogel and cartilage cells. This is the first time the device has been clinically tested – trials will still need to be conducted on a total of 11 patients in California and Texas.
One of the biggest challenges in the bioprinting industry is the clinical trial phase. It is critical that the safety, efficacy and durability of implants and organs designed by 3D printing is guaranteed. In fact, even if you have certainly heard about bioprinted hearts, 3D printed kidneys, etc, this stage is the biggest obstacle to long-term production. Indeed, there is still a long way to go before these solutions are implanted in a patient, but this ear transplant is a more than encouraging start! In fact, the FDA has even granted the implant AuriNovo™ Orphan Drug and Rare Pediatric Disease Designations, essentially naming it as safe for use in individuals with microtia.
Existing treatments to correct microtia involve designing a prosthesis from cartilage taken from the patient’s ribs – a very cumbersome operation. This prosthesis can also be made from porous polyethylene, a less flexible substance. This is where 3D printing has a card to play. Dr. Arturo Bonilla is the surgeon who performed the surgery on the young woman commented: “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. 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..”
Creating the 3D Printed Ear Implant
The first step in manufacturing the implant is to remove cartilage from the patient’s right ear – the teams specify that half a gram is sufficient. A 3D scan of the left ear is performed in parallel. 3DBio Therapeutics then isolates the cartilage-forming cells from the sample and grows them in a proprietary nutrient mixture, allowing the cells to multiply. These cells are then mixed with the company’s own bio-ink, which is inserted into the syringe of the bioprinter. In only 10 minutes, a replica of the patient’s ear could be made, layer by layer.
Once the printing process was complete, the ear was enclosed in a biodegradable protective envelope and sent to Dr. Bonilla. The surgeon then performed the graft under the patient’s skin. The shape of the ear is clearly visible once the skin is tightened around the implant.
Professor Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, which initiated the first 3D printed kidney project, said of the bioprinted ear transplant, “It’s a big milestone. Ears have been implanted by hand. It’s now using a printer, which helps automate the process, which is important for the field. 3D printing is a really great tool to be able to automate the process. It brings automation, reproducibility. It brings reliability. It brings decreased cost.” It remains to be seen whether the other planned clinical trials will be as successful – we hope so! You can find out more about it in the press release HERE.