Written By Laura Clark (Profile to be added soon!)
Step right up, folks! It’s not a paper moon. Last month, 3DBio Therapeutics successfully created the world’s first 3D-printed ear. This federally regulated study represents the growing role of additive manufacturing technology in reconstructive surgery. And according to Grand View Research, the bioprinting market as a whole is set to grow 9.9% by 2030.
The Changing State of 3D Printing in Medicine
At present, the 3D printing market has seen success with plastic and lightweight metal external prosthetics that are artificially attached to the body. There are also advancements in the mass production of medical equipment and hyper-realistic medical models, but no study has been FDA-approved for implanting bioprinted materials in a human—until now.
Living Tissue Implants Have Arrived—But There Is Work To Do
3DBio Therapeutics is currently the only regenerative medicine company solving medical challenges with custom-engineered 3D-bioprinted living implants. Their most recent clinical trial provides a living-tissue ear implant for 11 patients with a primarily aesthetic birth defect called microtia.
And what’s the impact of a successful trial? About 1500 babies born in the United States each year have either microtia or a similar condition called anotia where the whole external ear is missing. The current procedure is highly invasive, where a part of the patient’s rib is removed and an ear is carved out of the bone, while this new procedure can be done in a few hours.
This is an exciting advancement in reconstructive surgery that will change lives, but keep in mind that combatting tissue rejection will be crucial to the success of the trial. Evaluating the immune response against biomaterials used for 3-D printed organs is the key to responding to potential complications in the patient.
From Print to Transplant: Here’s How They Did It
What makes this procedure unique is the 3-D printing material that the company calls bio-ink. This material promotes tissue regeneration and significantly decreases the chance of the patient’s body rejecting the implant.
1. Patient Undergoes Biopsy Procedure
The process begins with a surgeon harvesting a half-gram sample of the patient’s cells from the misshapen ear cartilage. Then, to create an exact prototype of the ear, the surgeon ships a scan of the patient’s healthy ear with the sample to 3DBio’s building in Long Island City, Queens.
2. Culturing the Cells in an Artificial Environment
At the company’s facility, the patient’s cartilage cells are isolated from the sample using 3DBio’s proprietary method, which creates billions of cells with a concoction of nutrients. The cells are multiplied until there’s enough material for the collagen-based bio-ink, which are used to print the ear implant.
3. Patient’s Multiplied Cells are Blended with the “Bio-Ink”
At this time, the exact ingredients and process for adding cells to the bio-ink are proprietary. But 3DBio’s Chief Scientific Officer, Nathaniel Bachrach describes blending the bio-ink as, “chocolate chips mixed into cookie dough ice cream.” That is some compelling imagery, Dr. Bachrach!
4. Ear Implant is Printed to Match the Healthy Ear
In less than ten minutes, the final ear implant product, AuriNovo™ is complete. This process involves feeding the bio-ink with a syringe into a 3D bioprinter with a specialized nozzle creating an exact copy of the patient’s ear into a model implant or Overshell.
Most importantly, the implant contains exact copies of the patient’s cells, which will decrease the chances of the body rejecting the implant.
5. Patient Receives Reconstructive Surgery
During surgery, 3DBio describes that the surgeon places the Overshell around the organic tissue of the patient, sutures the outside elements together, and implants the AuriNovo™ product under the skin.
So What’s Next For BioPrinting?
The results of the trial so far are proof of the concept that bio-ink is safe in the body and that its chemical properties assist in keeping all of the implant’s materials sterile.
James Iatridis, a laboratory lead at a Spine Engineering Laboratory at Mount Sinai’s School of Medicine says the success of the study will allow researchers to, “evaluate biocompatibility, and shape matching and shape retention, in living people”—beyond just the application in microtia patients.
However, Dr. Feinberg of Carnegie Mellon is quick to remind us that organ bioprinting will be a much longer journey. He says, “Just going from an ear to a spinal disc is a pretty big jump, but it’s more realistic if you’ve got the ear.”