3D-printed ear implants grown from patient cells head to clinical trials
There may soon be new hope for patients born with genetic defects that leave them with misshapen or missing ears. A new human clinical trial will test an implant known as AuriNovo, which uses a 3D-bioprinted ear grown from the patient’s own cells.
Microtia is a birth defect that affects the external part of a baby’s ear. This can range from a minor deformation that might be barely noticeable, to more severe forms where the ear is just a small lump of cartilage, or missing entirely. It can affect one or both ears, and in the worst cases can interfere with a patient’s hearing.
Current treatment options often involve plastic implants or ear reconstructions made from a patient’s own cartilage, harvested from their ribs, but that’s a very invasive procedure. So 3DBio Therapeutics has developed a new technique to 3D print ears from cells taken from the deformed ear.
First, cartilage-forming cells called chondrocytes are taken from a biopsy of the patient’s affected ear. These are expanded and grown in a lab culture system, before being mixed with a collagen-based bioink. This ink is then 3D printed into an implant that mirrors the size and shape of the unaffected ear. The end result is an implant called an AuriNovo, a more natural reconstructed ear that matures and develops over time, retaining the flexibility, elasticity and look of the real thing.
Now, the first patient has undergone the procedure as part of a phase 1/2a clinical trial into the safety and efficacy of the AuriNovo implant. Conducted by 3DBio and the Microtia-Congenital Ear Deformity Institute, the trial will follow 11 microtia patients for five years after the procedure.
The ability to 3D print ears using cartilage cells has been in the works for many years, progressing from cell cultures to implants in mice and finally to human tests. The company hopes that the new trial will not only give microtia patients new treatment options, but open up the possibilities to grow replacements for other cartilaginous body parts, like noses or knees.