The first clinical trial of a human cell-printed organ has been successful.
3DBio Therapeutics, a regenerative medicine manufacturing company, announced Thursday that a 20-year-old woman who was born with a dysplastic right ear received a transplant of an ear 3D-printed from her own cells.
Experts say the successful transplant, part of the first clinical trial of a successful medical application of the technology, is a stunning advance in the field of tissue engineering.
According to 3DBio Therapeutics, the printed shape of the new ear perfectly matches the shape of the woman’s left ear, and the company said the new ear transplanted in March will continue to regenerate cartilage tissue, making it look and feel like a natural one. ear.
“This is definitely a big deal!” said Adam Feinberg, a professor of materials science and engineering at Carnegie Mellon University in biomedical engineering.
Seven years of sharpening a sword
The woman’s reconstructive surgery results were announced by 3DBio in a press release. The company has not publicly disclosed the technical details of the process due to concerns over patent rights, making it harder for outside experts to assess it.
Federal regulators have reviewed the trial design and established strict manufacturing standards, and when the study is complete, the data will be published in a medical journal, the company said.
In addition, clinical trials including 11 patients are still ongoing.
Transplants can fail or have unexpected complications. However, because the cells are derived from the patient’s own tissue, the new ear is less likely to be rejected by the body, doctors and company officials said.
The success of 3DBio’s seven-year effort is one of several recent breakthroughs in the quest to improve organ and tissue transplantation.
The company has previously used 3D printing to produce custom prosthetics made of plastic and light metal, but the ear in this case, made from a small clump of cells extracted from the woman’s deformed ear, is the first known An example of a 3D printed organ made from living tissue.
The entire printing and migration process is divided into five steps.
It started with surgeons removing half a gram of cartilage from the woman’s microtia remnants, which he then sent, along with a 3D scan of her healthy ear, from San Antonio to the 3DBio building in Long Island City, Queens.
In the second step, in the 3DBio building, the patient’s chondrocytes are isolated from the tissue sample, grown in a proprietary nutrient solution, and multiplied into billions of cells.
In the third step, living cells are mixed with the company’s collagen-based bioink, “like chocolate chips into cookie dough ice cream,” says Nathaniel Bachrach, 3DBio’s chief scientific officer.
In the fourth step, the collagen is inserted into a dedicated 3D bioprinter through a syringe. This printer ejects collagen in a steady stream from the nozzle and rotates rapidly to form a mirror image replica of the patient’s healthy ear. The entire printing process is only Lasted less than 10 minutes.
In a fifth step, the printed ear shape is then wrapped in a biodegradable protective shell and shipped overnight in a freezer to the surgeon, who then implants the ear under the patient’s skin, right in her jawbone. above.
An external doctor is the main surgeon, and other organs can be printed in the future
The patient is from Mexico with congenital microtia, a rare birth defect that causes the pinna or the outside of the ear to be small and deformed (it can also affect hearing in the ear).
After the ear was printed, a transplant was performed, performed by a doctor outside the company.
“It’s so exciting that sometimes I have to adjust myself a little bit,” said Dr. Arturo Bonilla, a pediatric ear reconstructive surgeon in San Antonio who performed the implant on the woman. The trial was funded by 3DBio Therapeutics, but Dr. Bonilla has no financial stake in the company.
With more research, the technology could be used to create many other replacement body parts, including intervertebral discs, noses, knee menisci and reconstructive tissue after lumpectomy, company executives said.
In the future, 3D printing could even produce more complex vital organs, such as the liver, kidney and pancreas, they say.
Other printed tissue implants are in development, said James Iatridis, director of the Spine Bioengineering Laboratory at Mount Sinai’s Icahn School of Medicine, but he’s not aware of others in clinical trials.
“This 3D ear is a proof-of-concept that can be used to assess biocompatibility, shape matching and shape retention in living humans,” said Dr. Iatridis.
Still, the outer part of the ear is a relatively simple appendage, more cosmetic than functional.
Dr. Feinberg of Carnegie Mellon University cautions that the road to solid organs such as the liver, kidneys, heart and lungs is still long.
“It’s quite a jump to go from an ear to a spinal disc, but if you’re missing an ear, it’s more realistic,” he said.
Using collagen-based “bio-ink”
The 3D printing manufacturing process creates a solid, 3D object from a digital model. The technique typically involves a computer-controlled printer depositing thin layers of material to create the precise shape of the object.
The new ear implant from 3DBio Therapeutics integrates several proprietary technologies, starting with a method for replicating billions of small samples of a patient’s cells, senior executives said.
The company’s 3D printer uses a collagen-based “bio-ink” that is safe in the human body and keeps all materials sterile.
All research and production take place in the same place, in a new, unremarkable brick building in Queens, equipped with a hygienic “lab” staffed with masks and full smocks, gloves and boots .
So far, the clinical trial has included 11 volunteers, ages 6 to 25, who will be followed for five years to assess long-term safety and aesthetics.