Tissue engineering is a hot area of research these days, with plenty of breakthroughs being made. But scientists are having problems bringing tiny cultures from the lab into the industrial world of mass production.
The Technology Review has an article describing the hurdles facing one of the more promising tissue engineering projects: the bioartificial kidney. Here’s an excerpt from the article:
The bioartificial kidney is one of the most promising examples to date of a bioengineered medical device. The innovative, external device passes blood through a cartridge of human kidney cells. In early clinical trials, it was shown to improve patient survival one month after treatment better than dialysis alone. But scientists now face a challenge that may be as great as designing the device itself: turning a successful academic invention into a mass-produced medical device.
“The question is, How do you turn 100 donated kidneys into 100,000 devices?” says David Humes, an internist at the University of Michigan, in Ann Arbor, and creator of the device. “You have to isolate the cells, expand them, and make sure they haven’t lost any potency in the process.”
In the United States, 400,000 people have chronic kidney problems that require weekly dialysis, and 120,000 suffer acute renal failure, in which kidney function is knocked out by toxins or infection. Dialysis extends the lives of these patients, but it’s not a cure: life expectancy for most patients is just five years.
Traditional dialysis filters and discards metabolic waste from the blood, and then returns cleansed blood to the patient. Humes’s artificial kidney, also known as a renal assist device, adds an extra step to this process, passing blood and filtrate through a cartridge of human kidney cells…
Both Humes and Lysaght liken the problem to that faced twenty years ago by researchers working with recombinant proteins, such as human insulin. Scientists could successfully make the proteins in the lab, but it took several years to figure out how to scale up that process for broad medical use. Lysaght says he’s confident the same will be true for tissue-engineered products once people recognize the extent of the problem.
If RenaMed can clear the hurdle, it may be able to lead the way for other bioengineered devices. “If there ever was a fair-haired child in tissue engineering, it was this device,” says Lysaght. “Everyone is hoping it will be a big success.”
We were under the impression that engineering fair-haired children was unethical, but to each his own. Hopefully any advances made in the manufacturing process for this particular device should translate over to other promising tissue engineering projects.
Read the whole article here…