Behind the barrier at the Spring Point Project facility in New Richmond, Wis., the general rule is: Don't scratch.
A touch to your face or the top of your head, or even pushing up a pair of glasses sliding down your nose -- any place on your body that hasn't been sterilized -- would mean you'd immediately have to stop what you're doing and put on a new pair of gloves.
That's if you're one of seven people in the world allowed inside the barrier: those who have submitted blood and fecal samples to prove they're free of pathogens that could infect the 120 or so pigs inside.
In a year, Spring Point researchers and administrators hope the pigs will give birth to piglets that will be the first in the country to have their islet cells transplanted into humans, which could lead to a cure for diabetes. They hope to achieve the goal by 2014.
Producing a cure
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Both the pigs and piglets will never see the light of day, another in a long list of precautions to ensure they remain free of pathogens that could be transmitted when their cells are transplanted. It's one of several requirements by the Food and Drug Administration before clinical trials can begin, said Tom Cartier, a Duluth businessman and co-founder of Spring Point.
As Cartier helps position the program for the start of clinical trials, he also is preparing for its next research center, working to secure nearly $80 million to make it possible.
"But one virus, one strain of bacteria could get in, and we'd have to start all over again," said Henk-Jan Schuurman, Spring Point's CEO -- who is not allowed inside.
About 24 million people in the U.S. have diabetes, which occurs when the body fails to produce enough insulin. The disease is a leading cause of death and disabilities such as blindness and amputations. Transplants of human islet cells into diabetics have reversed the disease but are not a viable cure for diabetics because there aren't enough donors.
Spring Point researchers believe pig islet cells will solve that problem.
"We used to hesitate using the word 'cure,' " said Cartier, who led the effort to open the facility. "We don't anymore. We believe this will be the cure."
Sterile safeguards
Access to the 21,000-square-foot, $6.2 million facility is rarely allowed. On Tuesday, the News Tribune was the first media outlet allowed to tour non-secure portions of the facility since it opened last February.
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Inside is a sterile,
hospital-like atmosphere where only a few hallways and labs are open to visitors; the pigs are visible only through one window.
The employees who work there must not only be able to perform medical procedures on the pigs but also perform basic tasks such as taking out the trash or cleaning the pigs' pens, facility director Mike Martin said.
Any tools brought into the facility must be sanitized with a hydrogen solution. Calling a repairman to fix a broken computer isn't an option.
"I'd say 99 percent of the things that break in there, we fix," Martin said.
The employees aren't allowed in with the pigs if they're sick or if they've been in recent contact with other animals.
"If you have a sore throat, you're not allowed inside," said Martin. "If you have swollen lymph nodes, you're out."
The precautions and stakes are so high that the doctor directing the research efforts, Bernhard Hering, a professor of surgery with the University of Minnesota, hasn't been to the facility since last year. The center wouldn't have been conceived if it hadn't been for Hering, who helped transplant pig islets cells into diabetic monkeys, some of which were diabetes-free for more than a year.
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More research to come
While researchers work to get FDA approval to begin clinical trials, Cartier's next mission will be to open a first-of-its kind facility to house enough medical pigs to provide islet cells to diabetes patients.
Fundraising for the
$80 million facility got off to a good start. The founder of Best Buy, Richard Schulze, and his family foundation gave $40 million to University of Minnesota researchers, much of which Cartier said will go toward Spring Point. Another
$20 million to $30 million will come from donors who don't yet want to be identified, Cartier said, with part of that money being designated for the next facility.
Cartier acknowledged there are risks involved in building a facility before trials show the islet cell treatment will work.
"It's like putting the cart before the horse; but we did it before, and we'll do it again,' he said. "I'm not worried about it; I should be, but I'm not."
