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Bio-printing human parts will spark ethical, regulatory debate

Lucas Mearian | Jan. 30, 2014
The day when 3D-bioprinted human organs will be readily available is drawing closer, and will result in a complex debate involving a great many political, moral and financial interests.

Organovo's bio-printing technology creates functional human tissue. The company's bio-printer places a specially formulated "bio-ink" made of human cells into a 96 well plate. The process results in tissue with natural architecture that can be tested for drug development. It can also produce tissue for human transplant.

Clinical trials and testing of organs for transplants in the U.S. could take up to a decade because of stringent reviews by the U.S. Food and Drug Administration (FDA). But 3D bio-printing is advancing unabated in other countries with less-restrictive government oversight.

"What's going to happen, in some respects, is the research going on worldwide is outpacing regulatory agencies ability to keep up," Basiliere said. "3D bio-printing facilities with the ability to print human organs and tissue will advance far faster than general understanding and acceptance of the ramifications of this technology."

For example, in August 2013, the Hangzhou Dianzi University in China announced it had invented the biomaterial 3D printer Regenovo, which printed a small working kidney that lasted four months. Earlier in 2013, a two-year-old child in the US received a windpipe built with her own stem cells, Basiliere said.

Munich-based EnvisionTEC is selling a 3D printer called a Bioplotter that sells for $188,000 and can print 3D pieces of human tissue. EnvisionTEC's Bioplotter uses a computer-driven syringe system to lay out cellular structures, Basiliere said.

"These initiatives are well-intentioned, but raise a number of questions that remain unanswered. What happens when complex enhanced organs involving nonhuman cells are made? Who will control the ability to produce them? Who will ensure the quality of the resulting organs?" Basiliere said.

EnvisionTEC's Bioplotter uses a computer driven syringe system to lay out cellular structures.

The Gartner report also notes that as 3D printing technology continues to mature, its ability to build customized human anatomical parts has pervasive appeal in medical device markets especially in economically weak and war-torn regions where it addresses high demand for prosthetic and other medical devices.

In addition, better familiarity within the material sciences and computer-augmented design services sectors, along with integration with healthcare and hospitals, will further increase demand after next year.

At the same time, 3D printing of non-living medical devices such as prosthetic limbs, combined with a burgeoning population and insufficient levels of healthcare in emerging markets, is likely to cause an explosion in demand for the technology by 2015.

"The overall success rates of 3D printing use cases in emerging regions will escalate for three main reasons: the increasing ease of access and commoditization of the technology; ROI; and because it simplifies supply chain issues with getting medical devices to these regions," Basiliere said. "Other primary drivers are a large population base with inadequate access to healthcare in regions often marred by internal conflicts, wars or terrorism."

 

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