3DBio Therapeutics said it had for the first time used 3D printing to make a body part with a patient’s own cells.
Alexa was born with a congenital disorder called microtia, which caused her to have a small and misshapen right ear. In order to provide her with a new ear, Dr Arturo Bonilla, a paediatric ear reconstructive surgeon in San Antonio removed half a gram of cartilage from the patient’s ear remnant and sent it to a laboratory along with a 3D scan of her healthy ear. The result was a brand new ear created from the patient’s cells.
The printing process took less than 10 minutes.
Cornell-founded start-up 3DBio Therapeutics was the New York-based company behind the “revolutionary” transplant. Independent experts said that the procedure, which was part of the first clinical trial of a successful medical application of this technology, was a stunning advance in the field of tissue engineering. The new ear, transplanted in March, will continue to regenerate cartilage tissue, giving it the look and feel of a natural ear, the company said.
“Not only is this an application you’ve never seen before, it’s made with a technology you’ve never seen before,” said Lawrence Bonassar, one of the company’s co-founders. “Even tissue-engineered implants in general, there just aren’t that many of them on the market, or even in clinical trials.”
At 3DBio Therapeutics’ facility, Alexa’s chondrocytes, the cells responsible for cartilage formation, were isolated from the tissue sample and grown in a proprietary slurry of nutrients, turning them into billions of cells. These were inserted into a specialised 3D bio-printer with a syringe and turned into a small oblong shape that was a mirror replica of the patient’s healthy ear.
Alexa’s ear before the transplant (left) and the results 30 days after the procedure (right)/3DBio Therapeutics and Microtia-Congenital Ear Institute
There are two current treatments for microtia. The first involves surgically harvesting rib cartilage from a patient, carving the cartilage into the shape of an ear and then creating a pocket of skin on the side of the patient’s head that will hold the newly shaped ear. The second approach uses plastic implants, usually made from porous polyethylene, that are implanted in a similar fashion. Now, the 3D-bioprinting platform potentially offers patients an alternative solution.
“I think my self-esteem will go up,” she said.
The technology is still being tested in an ongoing clinical trial that includes 11 patients. Although not enough time has passed to assess the rate of organ rejection, the doctors expect it to be low, since the transplanted organs were made from the patients’ own cells.
The company has, however, not publicly disclosed the technical details of the process, citing proprietary concerns, which also make it more difficult for outside experts to evaluate. Nonetheless, 3DBio Therapeutics said that federal regulators had reviewed the trial design and set strict manufacturing standards, and that the data would be published in a medical journal when the study was complete.
If successful, this new approach could eventually lead to tissue implants for treating other conditions and traumatic injuries, reconstructive and regenerative therapy, and possibly even the biomanufacture of whole organs.
“As a physician who has treated thousands of children with microtia from across the [United States] and around the world, I am inspired by what this technology may mean for microtia patients and their families,” Bonilla said.
“This is so exciting, sometimes I have to temper myself a little bit. If everything goes as planned, this will revolutionise the way this is done.”
Source: E&T
