Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of available kidneys, livers, hearts, and lungs, at least 17 of them die each day.
Using 3D bioprinting to create new organs — and personalize them for recipients — could prevent these tragic deaths. Yet inaction at the Food and Drug Administration is impeding the rollout of this technology. Regulators have not yet come up with a framework for reviewing and approving these lab-grown organs. Until they do, Americans awaiting organ transplants will continue to suffer.
These people already face long odds. A willing donor must die or, in the case of kidney transplants, a living donor must agree to a major procedure. Donors’ organs need to match the potential recipients’ blood types and body sizes. Because many organs can only be preserved for hours, potential recipients need to stay near hospitals so they can undergo transplantation at a moment’s notice. And the organ must be delivered on time to the recipient.
No wonder so many people languish for years on transplant wait lists.
And for those lucky enough to secure an organ transplant, there’s no guarantee of success. By one estimate, around half of new organs are rejected by recipients’ bodies within 10 to 12 years.
3D bioprinting can help overcome these challenges.
The process involves printing human tissue layer by layer using cells that are genetically identical to those of the recipient. Scientists harvest these cells from a transplant recipient and grow them in the lab. They then use a 3D printer to arrange those cells to create the tissue the patient needs.
This technology looks more promising by the day. Fifteen years ago, Anthony Atala and his team at Wake Forest University made history by successfully transplanting a lab-grown human bladder into a patient.
A new documentary called “They Say It Can’t Be Done” highlights the real-world impact of this technology. The film features Luke Massella, one of the first people to receive a lab-grown human bladder. Atala’s invention allowed Massella to have a high school sports career, graduate, and attend college instead of remaining on dialysis for the rest of his life.
More recently, researchers at Carnegie Mellon University have found a way to bioprint full-scale components of the human heart. Last month, a team at Lund University in Sweden announced a new “bioink” that can be used to print lung tissue.
Scientists are eager to turn this cutting-edge research into tangible, widely available solutions. But they are running into regulatory barriers at the FDA.
The FDA was established to handle mass-market products like drugs and medical devices that can be evaluated through a systematic process of clinical trials. Its statutory framework and traditional approach don’t mesh neatly with a technology as unprecedented as 3D bioprinting.
Determining the safety and efficacy of 3D printed organs requires a different approach than the FDA is used to. Instead of being mass-produced therapies, bioprinted organs are one-of-a-kind creations, tailor-made for each patient. This fact alone warrants new standards, procedures, and guidelines.
In 2017, the FDA announced its intention “to review the regulatory issues related to the bioprinting of biological, cellular, and tissue-based products to determine whether additional guidance is needed.” So far, though, such guidance has not yet materialized.
The agency’s failure to act is a major impediment to this lifesaving innovation. Turning a promising scientific discovery into a real-world medical treatment almost always requires large amounts of private funding. Even in the best of circumstances, the risks of investing in an unproven technology are considerable. Those risks become impossibly high in the absence of a framework for regulating this new technology and bringing it to market.
For 3D bioprinting technology to reach its full potential, billions of investment dollars will be needed. That will be possible only if the FDA provides clear, predictable rules and standards for this new area of medicine.
3D bioprinting represents an excellent chance of helping end the organ shortage. Potential transplant recipients shouldn’t perish on waitlists while the needed guidance for this technology languishes in regulators’ inboxes.
Dan Troy is the executive vice president and general counsel of Boston-based Valo Health, cochair of the Regulatory Transparency Project’s FDA and Health Group, and a former chief counsel for the FDA. The opinions expressed here do not represent the views of any company he is affiliated with, and he reports no financial interest relating to organ bioprinting.