Could a biological cure for type 1 diabetes come from the far reaches of the universe?
Maybe, if former astronaut and diabetes researcher Dr. Taylor Wang has anything to say about it.
Almost 30 years before the movie Gravity hit the silver screen, Wang was exploring science in space and made a micro-gravity discovery that's now a fundamental part of his work on an implantable patch that would encapsulate islet cells and allow people with diabetes (PWDs) to begin making their own insulin again. It's all very Twilight Zone...
In the past two weeks, his company Encapsulife has gotten word that this encapsulation patch is now patented by the U.S. Patent and Trademark Office. And for the Encapsulife team, that means it's time to ratchet up their public profile and prep for late-stage clinical studies that could lead to human trials in the coming year.
Wang's work is suddenly getting more attention now than it has in the past 17 years of R&D, and it's fascinating to look back on how it all began in space in April 1985, during one of the last missions of the historically tragic Space Shuttle Challenger that made history less than a year later with the fatal explosion killing all astronauts on board.
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Space, Gravity and Diabetes Research
A researcher at Vanderbilt University in Nashville, TN, Wang started his work on this bio-artificial pancreas patch known as Encapsulife based on his 1985 observations in space; he was literally doing research in zero gravity aboard the ill-fated Space Shuttle Challenger. Wang was heading up California Institute of Technology's Jet Propulsion Labratory when he was chosen by NASA, making him the first ethnic Chinese person to go into space -- as a payload specialist and one of seven astronauts on a week-long STS-51-B mission focused on microgravity research.
What he saw in space was unique and formative, according to research-watchers like the JDRF; in science-speak, it involved "polymer capsule growth and performance." In layman's terms, he studied how rotating sphere-like shapes behaved in zero gravity and found that droplets of water would migrate to the center of the spheres rather than move toward the edges. Using that research, Wang would go on in the 90s to create his immuno-isolation encapsulation system that protects living cells and lets them sustain their cell function, without the need for any immuno-suppression drugs that have so many negative side effects.
Basically, this patch would be a high-tech "pancake" made up of multi-layer polymer capsules that would form into different shapes to fit the transplant host. About the size of a silver dollar, it would implanted under the skin, holding tens of thousands of encapsulated living islet cells (whatever the source, either pigs, humans, or adult stem cells). It would protect the islets from any auto-immune attack, welcoming the digestive glucose from the liver and stimulating the islets to produce insulin and secrete it automatically into the diabetic person's system — just like a normal working pancreas.
It's really like a capsule inside a capsule inside another one -- and they all have a specific function. The Encapsulife folks say a "space capsule" really is the best analogy for how this patch works: a living being inside the capsule that's floating in a hostile or foreign environment.
Yes, Encapsulife does sound similar in concept to other encapsulation efforts we've been watching for years, including the Diabetes Research Institute's BioHub "mini-organ" project, Islet Sheet Medical's implantable business-card size device, Canada-based Sernova's cell pouch system that has ongoing clinical trials, Living Cell Technologies' tiny alginate capsule that would do much of the same, and ViaCyte's band-aid sized Encaptra encapsulation device that appears to be heading toward human clinical trials this year. Like most of the D-researchers working on specific products, each claims their particular effort is the most promising... apparently it's all in the eye of the beholder when it comes to diabetes cure research too.
But according to Wang's team at Encapsulife, their capsule truly is different. Unlike others, Encapsulife consists of numerous independent layers that each perform a particular task and aren't influenced by what the others are doing -- so, if one needs to be tweaked for better insulin absorption, the others would keep on track without needing their own adjustments.
Wang performed the first round of successful studies using rodents back in the 90s, and a decade later in 2007 he found that diabetic dogs could be off insulin with normal fasting blood sugars for up to seven months. Most recently in 2013, Wang worked with Dr. James Markmann at Massachusetts General Hospital to use the living cell patch to counteract diabetes in small monkeys without any immuno-suppressants.
One note: Wang hasn't yet figured out where the best location would be in the body for the patch to be inserted or how long it might last. Those key details are to come with more research that will hopefully follow for humans in the coming years.
But they're getting closer, and have recently gotten a boost in interest after hearing in late March that the USPTO finally approved their patent application for this patch. UPDATE: Encapsulife received a patent on May 1, 2014.
Now, the foundation is in the next wave of awareness-building and fundraising, according to D-Dad Tom Gibson who's one of the main advocates for Wang's research and has been involved in Encapsulife's efforts since the late 90s following his daughter Lucy's diagnosis at 4 years old.
Tom's connection with this concept goes back to the 80s too, as he learned early on about Wang's space shuttle observations and how they might be applied to novel diabetes research.
Tom is probably best known for his time serving in the Ronald Reagan Administration, first as associate director of White House Cabinet Affairs and later as director of White House Public Affairs from 1985 to 1987. He grew up in Indiana and studied political science at Princeton, and before his move into politics he was one of the first op-ed editors and political cartoonists at USA Today back when the newspaper began in 1982. He also did work for other high-profile publications like the Washington Post, New York Times and National Journal. After Tom's stint in the White House, he began consulting work that ranged from public affairs and energy, to life sciences and technology.
"Really, the only thing you could possibly do after all that is public affairs and consulting, so that's what I did," Tom says. "I consulted on technology, aerospace, and the twist was life sciences work for NASA supporting medical research on space stations. That's when I discovered Dr. Wang's work after Lucy's diagnosis in the late 90s."
"I have an activist gene in me, and so my way of coping was to get involved in the JDRF," Tom says, pointing out that his daughter was a part of the first JDRF Children's Congress in June 1999.
Since stumbling upon Wang's work, Tom says he's been a staunch supporter over the years, even as skeptics in the diabetes industry and medical community have dismissed Encapsulife.
Years ago, they developed the phrase "functional cure" to describe Encapsulife's work, which basically distinguishes between a biological cure versus an advanced mechanical treatment like an artificial pancreas device.
He describes his work on Wang's team as a labor of love, and really he just helps promote what the researcher is doing.
"I feel like a bat boy to Babe Ruth here," Tom said. "Dr. Wang is a physicist and rocket science, literally, and he's been hacking away in a lab for decades with the single focus of doing this. My job has been trying to translate that business into lay language, while he perfects the technology."
Tom describes Encapsulife's evolution like creating the light bulb -- it was a breakthrough but the first iteration lasted only 12 minutes, yet over time that lighting life was extended and perfected. That's where encapsulation is now, he says.
"We are... already discussing a major improvement which we think might even establish some new science and lead to better longevity over the current designs," he said.
If funding dollars come in as hoped, Tom says human trials could start within a year and then hopefully the FDA submission wouldn't be far off thereafter.
Raising Money and Awareness
Encapsulife faces the classic challenges of any such concept: raising capital and public interest, not necessarily in that order.
In the years since Wang's research on Encapsulife began, there have been a number of private donors along with JDRF and NASA. A handful of other D-parents serve as officers of the company, along with Wang who's the chairman and CEO. Gibson also runs the Washington D.C. non-profit New Generation Foundation, aimed at raising awareness and funding to support a cure for diabetes while also supporting other programs to "promote access to opportunity for young people."
But one of the most visible grassroots fundraising initiatives they have is called Squash Diabetes, created by Lucy's college squash team at Georgetown University. Now 20 years old and a junior studying psychology, Lucy's been part of the squash team since her freshman year, a year her dad says wasn't easy in terms of diabetes. The week of her very first college match, Lucy was sick and ended up in the hospital because of DKA. She recovered and was able to play, against the advice of her dad and coach, and ended up winning the match. When asked why she insisting on playing, she told her dad: "I didn't want to let diabetes beat me."
The squash team got behind her and created the appropriately named Squash Diabetes effort, supporting Wang's research on Encapsulife. Of course "squash" is play-on word here, referring to both the sport and also the aggressive approach to managing and curing type 1.
"We're using all the tools we have, because we believe in this so much," Tom says. "It's been a long road, and we're excited to be pushing the development button soon."