For the first time ever, Israeli scientists in Tel Aviv made a 3D printed artificial heart using a patient’s own cells," proclaims a Washington Post story headlined ‘Researchers create 3D printed heart’ on April 17 this year.
In the scientific paper published two days earlier, the Israeli scientists describe how they made a ‘bioink’ out of heart cells and other materials from a patient, and then bioprinted the tissue in the shape of a tiny heart, which was kept alive in a nutrient solution. Their paper makes it clear that this 3D printed ‘heart’ could not function like a real heart. But the way the research that was projected in media shows how the idea of 3D printed organs is hyped.
Biotechnology has made significant advances, but it’s still a long way from creating organs that can be transplanted into people. The vasculature—the network of blood vessels that feeds the organ—is a challenge.
Stem cell engineering to grow all the cells of an organ in a personalised way to avoid rejection by the recipient’s immune system is another challenge. And finally, researchers will have to show that a lab organ will work with all the other organs in a human body.
At the same time, the development of 3D bioprinters in the last few years has raised the prospects of making tissues and organs in a more affordable and consistent way because of the speed and precision of the machines. Advances in related fields like nanotechnology and gene editing are also pushing the needle.
These are exciting times, but for startups rushing into this nascent field with huge potential, it’s as important to be prudent as brave. One way is to go after low hanging fruit instead of the holy grail.
Shift to clinical use
“Something like skin is easier to translate into a clinical setting," says Alok Medikepura Anil, director and co-founder of Bengaluru-based 3D bioprinting startup Next Big Innovation Lab (NBIL), which has made human skin in the lab. “The skin has good regenerative properties and most of the function of bioprinted skin is to keep infections away, provide nutrition for skin to regenerate and stop the scarring of wounds. Replicating this is easier than replicating the function of a critical organ such as the heart."
This approach contrasts with that of another Bengaluru-based 3D bioprinting startup Pandorum Technologies, founded in 2011 by two researchers at Indian Institute of Science. Pandorum first tried its hand with liver tissue and more recently announced that it had bio-engineered corneal tissue.
“Organ tissue for clinical use will require FDA and other approvals. So that’s a very expensive proposition," says angel investor Venkat Raju, who took an interest in Pandorum but eventually made a bet on NBIL whose proprietary Innoskin also has non-clinical use in cosmetics testing.
The regulatory environment is evolving. This year, FDA released an RMAT (regenerative medicine and advanced therapy) policy that includes tissue engineering. “The FDA wants to fast-track tissue-engineered products if they have a lot of benefits," says Pooja Venkatesh, NBIL co-founder.
Raju feels that startups like NBIL gaining traction and validation could bridge the current gap between academic research and business.
“There’s tonnes of research happening across the globe on bioprinting. But universities are struggling to commercialize their research. The fact that NBIL is getting receptive audiences in academia is because they see an opportunity to push their research out."
The Wake Forest Institute of Regenerative Medicine in the US is one of the leading institutions for research in this field. Researchers there are growing tissues for over 40 different areas of the body. They were the first to transplant a lab-grown organ into a 10-year-old patient.
Dr Anthony Atala, who is now the director of the institute, had taken a piece of the boy’s bladder and grown a new one in the lab over the course of two months. The lab-grown bladder was then transplanted into the patient.
That boy, Luke Massella, went on to become the captain of his school wrestling team. “Pretty much I was able to live a normal life after that," Massella, who is now 28, said in a recent interview on BBC.
Stories like that of Massella stoke excitement over futuristic scenarios where you could get made-to-order organs. But researchers admit that there are many unsolved problems in tissue engineering before complex organs like the heart, kidney and liver can be bioprinted. The crash of well-funded San Diego 3D bioprinting startup Organovo, which hit a brick wall in commercializing liver tissue, reminds us to keep the hype in check.
Sumit Chakraberty is a contributing editor with Mint. Write to him at firstname.lastname@example.org.