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3D-Printed Ear from Patient’s Cells Successfully Implanted

In news that’ll certainly be music to many ears, a surgeon-led team in Texas was able to successfully implant what it says is the first ear to be 3D-printed using the patient’s own cells. The procedure took place at the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas, using technology developed by New York-based 3DBio Therapeutics. It marks the first of what the partners are hoping will be 11 implants in a first-in-human clinical trial that’ll span the Texas institute and Cedars-Sinai Medical Center in Los Angeles.

3DBio’s AuriNovo uses 3D-printing technology to form an ear out of a patient’s auricular cartilage cells using a 3D scan of their opposite ear for guidance. The technology offers a less invasive implant process and a more accurate reconstruction than currently used methods to treat microtia, which rely on harvested rib cartilage grafts or inflexible porous polyethylene implants. The AuriNovo implant is constructed using 3DBio’s own cell processing technology to rapidly expand a clump of cells taken from the patient’s impacted ear. Those cells are combined with the company’s sterile bio-ink to fill out the rest of the implant.

Microtia is a congenital deformity that leads to small, improperly formed or completely absent outer ears and can impact hearing. It is a rare condition which affects anywhere between 1 in 2,000 and 1 in 10,000 babies born in the U.S. each year, per the Centers for Disease Control and Prevention. The first patient in the trial was a 20-year-old woman whose right ear was small and misshapen at birth, according to The New York Times. The replacement ear, implanted in March, is a perfect match for her left ear and, like its twin, is able to regenerate cartilage tissue to help it heal naturally.

3DBio Therapeutics and Microtia-Congenital Ear Deformity Institute are collaborating on a clinical trial aiming to create bioprinted implants for 10 more patients with microtia. Arturo Bonilla, M.D., a pediatric ear reconstructive surgeon and the founder and director of the Microtia-Congenital Ear Deformity Institute, led the procedure. Future participants in the trial will be split between Bonilla’s team and another led by John Reinisch, M.D., director of craniofacial and pediatric plastic surgery at Cedars-Sinai.

“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,” said Daniel Cohen, Ph.D., CEO, and co-founder of 3DBio. Cohen noted that success in the microtia trial will also determine where 3DBio next directs its technology-expanding beyond cartilage-focused procedures to treat nasal and spinal defects into lumpectomy reconstruction and, potentially, organs.

What is anotia and microtia?

Anotia and microtia are birth defects of a baby’s ear. Anotia happens when the external ear (the part of the ear that can be seen) is missing completely. Microtia happens when the external ear is small and not formed properly. Anotia/microtia usually happens during the first few weeks of pregnancy. These defects can vary from being barely noticeable to being a major problem with how the ear formed. Most of the time, Anotia/microtia affects how the baby’s ear looks, but usually the parts of the ear inside the head (the inner ear) are not affected. However, some babies with this defect also will have a narrow or missing ear canal.

Treatment

Treatment for babies with anotia/microtia depends on the type or severity of the condition. A healthcare provider or hearing specialist called an audiologist will test the baby’s hearing to determine any hearing loss in the ear(s) with the defect. Even a hearing loss in one ear can hurt school performance. All treatment options should be discussed, and early action may provide better results. Hearing aids may be used to improve a child’s hearing ability and to help with speech development.

Surgery is used to reconstruct the external ear. The timing of surgery depends on the severity of the defect and the child’s age. Surgery is usually performed between 4 and 10 years of age. Further treatment may be necessary if the child has other birth defects present.

In the absence of other conditions, children with anotia/microtia can develop normally and lead healthy lives. Some children with anotia/microtia may have issues with self-esteem if they are concerned with visible differences between themselves and other children. Parent-to-parent support groups can prove to be useful for new families of babies with birth defects of the head and face, including anotia/microtia.

Source:

  1. https://www.fiercebiotech.com/medtech/ear-3d-printed-patients-own-cells-implanted-successfully-first-human-trial
  2. https://www.cdc.gov/ncbddd/birthdefects/anotia microtia.html#:~:text=anotia%20and%20microtia%3F-,Anotia%20and%20microtia%20are%20birth%20defects%20of%20a%20baby’s%20ear,first%20few%20weeks%20of%20pregnancy.

Author

Dr Shilpa Subramanian

Dr. Shilpa Subramanian is a MDS, Periodontist and currently manages Global Pharmacovigilance and Medical Affairs Operations at a Healthcare company in Mumbai. She is passionate about staying ahead of the curve in clinical and non-clinical advances in the field of pharma and healthcare.

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