First 3D printed ear made with human cells transplanted
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3DBio Therapeutics says the company has completed its "first-in-human" implant in a clinical trial. Photo: 3DBio Therapeutics
The first 3D printed ear implant has been successfully transplanted on a 20-year-old woman as part of an ongoing clinical trial.
Driving the news: 3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute announced Thursday that they conducted the human ear reconstruction using a living tissue ear implant.
The company said it’s the first implant and creates “an entire suite of processes and engineering solutions required to support the technology platform.”
Why it matters: Microtia, a rare congenital deformity where one or both outer ears are absent or underdeveloped, affects approximately 1,500 babies born in the U.S. annually.
- The new ear was printed in a shape that matches the woman’s left ear, according to 3DBio, a regenerative medicine company based in Queens, New York.
- AuriNovo, the name of the implant, is designed to provide a “treatment alternative to rib cartilage grafts and synthetic materials traditionally used to reconstruct the outer ear of microtia patients,” the company said, noting the FDA granted the implant, “Orphan Drug and Rare Pediatric Disease Designations.”
What they’re saying: The successful application of the technology is considered a major advance in the field of tissue engineering, experts told the New York Times.
- Adam Feinberg, a professor of biomedical engineering and materials science and engineering at Carnegie Mellon University, who is not affiliated with 3DBio, told the Times that the advancement was “definitely a big deal.”
- “It shows this technology is not an ‘if’ anymore, but a ‘when,’” Feinberg, a co-founder of regenerative medicine company FluidForm, told the Times.
- However, the company has not released technical details about the process, the Times notes, making peer evaluation of the science difficult.
What’s next: A clinical trial is being conducted in Los Angeles and San Antonio, Texas, and expects to enroll 11 patients.
- Daniel Cohen, Ph.D., 3DBio CEO and cofounder, said initial indications focus on “cartilage in the reconstructive and orthopedic fields including treating complex nasal defects and spinal degeneration.”
- “We look forward to leveraging our platform to solve other high-impact, unmet medical needs like lumpectomy reconstruction and eventually expand to organs,” Cohen said.
