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Trial Demonstrates 3-D Printed Ear Tissue Implant

Human ear

(Nigel Durrant, Pixabay.

2 June 2022. A patient in a clinical trial received an implant made of three-dimensional printed tissue to replace a deformed ear caused by microtia, a congenital condition. The 3-D printed ear tissue is made by 3DBio Therapeutics in New York, and surgically implanted by a team from the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas.

Microtia is the name for a class of congenital tissue abnormalities that result in deformed outer ears often smaller than normal size, or in some cases not formed at all. According to the Microtia-Congenital Ear Deformity Institute, the condition is most likely to occur from decreased blood flow to the fetus. Microtia, says the institute, occurs more often in males than females and with the right ear, although in 10 percent of the cases, both ears are affected. In addition, most people with microtia have no ear canal. The condition occurs in one in every 6,000 to 12,000 births, or some 1,500 cases per year in the U.S.

3DBio Therapeutics is a regenerative medicine company developing 3-D printed tissue implants for reconstructive and orthopedic use. For microtia, the company offers its AuriNovo process that generates replacement ear tissue from patients’ own ear cartilage samples. Cells from the tissue sample are expanded in the lab, then combined with biocompatible inks for 3-D printing. The replacement cartilage tissue is custom-printed for each patient on a hydrogel collagen scaffold. The company’s process is based on research by its scientific founders Lawrence Bonassar and Hod Lipson, medical and engineering professors at Cornell University. Science & Enterprise first reported on their research in February 2013.

Less invasive surgical procedure

The first implant of replacement ear tissue was performed as part of an early- and mid-stage clinical trial testing the AuriNovo process with 11 children and young adults, age 6 to 25. Arturo Bonilla, who founded the the Microtia-Congenital Ear Deformity Institute, led the surgical team for the first implant. The trial also expects to enroll participants at Cedars-Sinai Medical Center in Los Angeles. The study team is looking primarily for signs of adverse effects from the implants in the three months following surgery, but also satisfaction by patients with the outcomes.

Bonilla says the AuriNovo process is an improvement over current reconstructive processes for microtia using rib cartilage tissue or porous polyethylene or PPE plastics. “The AuriNovo implant,” says Bonilla in a 3DBio statement, “requires a less invasive surgical procedure than the use of rib cartilage for reconstruction. We also expect it to result in a more flexible ear than reconstruction with a PPE implant.”

Daniel Cohen, co-founder and CEO of 3DBio adds, “We believe that the microtia clinical trial can provide us not only with robust evidence about the value of this innovative product and the positive impact it can have for microtia patients, but also demonstrate the potential for the technology to provide living tissue implants in other therapeutic areas in the future.”

“Our initial indications,” notes Cohen, “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.”

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