In what the company is calling a "groundbreaking reconstructive procedure," 3DBio Therapeutics has transplanted a 3D-printed ear made of living cells. The reconstruction is the first in-human phase of the clinical trial for the implant, called AuriNovo, and appears to be the first 3D-printed implant made of living tissues.
The implant is specifically for patients with microtia, a rare congenital ailment where the outer ear is either underdeveloped or doesn't exist at all. According to the Centers for Disease Control and Prevention, it's hard to estimate just how many people are impacted because of the range of the ailment varies, but estimates show that the birth defect impacts about 1 in every 2,000 to 10,000 in the U.S. The cause, in most cases, is unknown, although some cases are caused by genetic changes or the use of isotretinoin, or Accutane medication, during pregnancy.
The patient who received the transplant is a 20-year-old woman from Mexico whose right ear is impacted by the ailment. She received the surgery in March, and will continue to be monitored for five years, a spokesperson for 3DBio told CBS News.
Dr. Arturo Bonilla, a pediatric surgeon at the Congenital Ear Institute, the largest pediatric microtia center in North America, led the transplant. In a statement, he said that he's "inspired" by what the advancement could mean for microtia patients.
Traditionally, doctors have to harvest rib cartilage or use porous polyethylene (PPE) implants to do this kind of transplant, both of which come with a set of challenges. Using rib cartilage, for example, requires a substantial harvest from at least three ribs and typically must be done in at least two separate hours-long procedures. It could result in a chest deformity, and the implants are rigid and can cause discomfort.
PPE implants typically requires taking a large section of skin from a patient's scalp, and because the implant is not made of biological material, there is early risk for infection and later risk of implant changes, discomfort and even a risk of the implant shattering.
Using a patient's own cartilage cells is less invasive, and according to Bonilla, will allow for a more flexible ear. He also said that for those who have microtia, getting such a surgery can drastically help with their self-esteem. While it is not believed to impact hearing, it does offer an aesthetic relief.
"An issue that becomes more prominent is bullying or teasing. Children don't understand that they're hurting somebody else's feelings, but it really does affect them in a major way. And that's usually when they start coming to my office, so that I can start taking care of them and helping them and advising them as far as what are the next options," Bonilla said. "...The new technology with AuriNovo is exciting. I've actually been waiting for this my whole career."
To create the new appendage, doctors conducted a biopsy on the ear of the patient that was impacted and extracted chondrocytes, the cells that create cartilage. Those cells were then expanded and mixed with what the company calls ColVivo collagen-based bio-ink before being molded with a 3D bioprinter into the size and shape of the patient's opposite ear.
Daniel Cohen, CEO and co-founder of 3DBio, said that the impact of this technology could go well beyond patients with microtia.
"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," he said. "...Our 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."
There are an estimated 11 people participating in the clinical trial, and doctors are continuing to enroll subjects. The study officially began in August last year. Pending the outcome of this trial, researchers will conduct a second and larger trial before seeking FDA approval of AuriNovo, which also been granted orphan drug and rare pediatric disease designations by the FDA, meaning that it will receive a priority review when ready.
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