Sorry, Mr. Pancreas, but your role in reversing type 1 diabetes could become irrelevant if the Diabetes Research Institute has anything to say about it.

Top diabetes researchers at the DRI plan to create a new mini-organ that would make the current efforts to transplant islet cells from a donated pancreas and into a person's liver a focus of the past.

Instead, the DRI is developing a small man-made receptacle that it's calling the BioHub, which would be filled with insulin-producing cells that could be implanted somewhere in your body. The idea is that this BioHub would take root, being able to house transplanted cells or even new insulin-producing cells down the road. Since this could mimic the role of a healthy pancreas and quite possibly "totally reverse" type 1 diabetes, DRI researchers are touting their effort as the "next quantum leap" toward a biological cure.

DRI is aggressively marketing this BioHub project, which DRI Next Quantum Leapit says brings together years of various avenues of diabetes research that the Florida-based organization has been involved with since its inception in 1971.

Naturally, we're always a little cautious about jumping up and down over anything being promoted as a "breakthrough" or the next great thing in diabetes research. We all know that mice have been "cured" and every other day there's a news headline about some major advancement. Not only that, but the DRI's been working on a similar receptacle for islet cells since at least 2006, when Amy reported on the implantable device then likened to a "reverse IUD."

When pressed on exactly what's "new" about this BioHub, the DRI told us that to date, the organization has been taking a "shotgun approach" pursuing three strategic lines of research through the years: restoring cells that produce insulin without the need for anti-rejection drugs, accessing transplanted cells or replacing insulin, and developing a mini-organ for cell transplantation.

Now, it all comes together into what will be the DRI's main project focus going forward, they tell us.

DRI previewed today's BioHub announcement in our 2012 Milestones post back in January. Apparently since then, what they've finalized is their marketing approach, giving a single name to what they've already been doing in islet cell transplantation research.

"Our master plan has always been to streamline everything, but this is the first time we've pulled the framework together to show how this all fits together like a puzzle," said DRI director Dr. Camillo Ricordi.

If it works out, this new mini-organ could be made out of a porous, sponge-like material the size of a quarter, and it would be compatible with the human body so that thousands of islet cells could be gently seeded onto this protective platform and nestle themselves inside individual pores to start producing insulin. Another idea is that the BioHub might take the form of a more natural container, like a person's own vein that could be tied off to create a "venous sac" complete with its own pre-existing vascular supply.

Either way, the BioHub platform would be the new home for thousands of transplanted or re-generated islet cells to grow and do their insulin-producing job, potentially reversing type 1 diabetes altogether. Although, Ricordi admits it might be possible that any BioHub like this would have to be replaced every 3-6 years.

The BioHub would also allow scientists to add oxygen and other types of "helper" cells that could promote the long term survival and functionality of cells within this platform, DRI spokes-folks tell us. Basically, the notion is "improving on what Mother Nature has given us naturally."

Dr. Jay Skyler, who serves as DRI deputy director of clinical research and academic programs, says that this mini organ would mimic the native pancreas and restore metabolic function and insulin release in real-time, something PWDs don't currently have available in any shape or form. And they really are convinced that it may be possible to "totally reverse" diabetes by finding an optimal spot in the body for this BioHub, according to DRI's deputy director of translational research, Dr. Luca Inverardi.DRI-BioHub

Their hope is to see the BioHub reach regulatory review stage and possibly even approval within five to seven years.

That's quite an ambitious goal! One that we can't help viewing skeptically, especially coming from an organization that has made huge promises in the past. Early on, they actually promised donors that they would develop a CURE within 10 years (!), and Amy witnessed a confrontation over donor disappointment at the DRI's annual conference in NYC in 2008.

Ironically, that event was focused on differentiating between "hope and hype." As a follow up, Amy wrote a column over a dLife about understanding diabetes headlines, and the incremental nature of progress in research. Still a good read!

Citing just that incremental nature, Ricordi insists that important progress has been made in islet transplantation research over the years, and has allowed the DRI to get to this "important juncture" -- though it's not exactly clear what this juncture might really be except renewed hope that this "cure" materializes as they envision it.

"The BioHub gives us a tool to combine all we've learned through the years of clinical testing and take the next leap forward," Ricordi said. "I am confident that this approach could move cellular therapies and biological replacement strategies for the cure of diabetes to our final goal."

This all sounded a little familiar to us, both in looking back on previous DRI news, and also from other organizations; Canada-based Sernova is also working on a similar Cell Pouch System, a small container designed to hold islet cells under the skin and provide a protective "pancreas-like" environment.

Ricordi saysDRI Logo what's important is that the DRI has fine-tuned its concept over the past decade. They've evaluated other approaches related to engineering an appropriate site for implanting islet or other cells, and incorporated some concepts in the current BioHub project, while discarding other lines of research because of downsides or limitations.

Specifically, that "reverse IUD" prototype envisioned seven years ago was unable to scale up because of problems with islet cell clumping and suboptimal engraftment of the cells, so the DRI has abandoned that initial design and related prototypes, Ricordi says. He also says the research on implanting islet cells in your eyeballs that we wrote about in 2011 is continuing, but mainly with other DRI researchers in Sweden and Seoul. He and his team in Florida are still interested in the eye as a test site for cell tolerance, but it is no longer the main focus as a transplant site.

"A lot of new features and advances have happened since that initial report and design," Ricordi tells us, pointing to research advances in new paths to investigate using stem cells, immuno-modulatory molecules, and oxygen-generating tech and drug delivery systems not available before. "We are therefore enthusiastic of the new knowledge and potential that these platform technologies will bring to the overall BioHub project."

What the DRI does know from global research is that islet transplantation does work, although it continues to have limitations (like the cost being upwards of $50,000!) and several challenges remain before it can be offered more broadly. Ricordi says this BioHub would be a way to address some of the current research challenges: the need for anti-rejection drugs, finding a plentiful supply of islet cells to transplant, and finding an optimal site within the body for these cells. Access to islet cells is limited, so Ricordi said part of this research involves studying how to use stem cells or reprogram other cells to produce insulin. Doing that would eliminate the need to inject other transplanted donor cells, he said.

An exact timeline for the BioHub isn't known, because in large part it will follow whatever timeline science and research dictate. Some pre-clinical studies are already underway, and Ricordi says they hope to begin the first clinical trials by the end of 2013 or early next year.

So is that 5-7 year time frame realistic at all?

 

"Yes, I believe it is realistic," Ricordi says. "The main road block that we envision right now is regulatory, not scientific. Science and funding are only a small part of the equation when you hit a brick wall to clinical translation."

Ricordi tells us that this is a collaborative project, with most of the research happening in Miami, FL, but other parts occurring throughout the world. That is, in part, dictated by other labs not being limited by the regulatory delays here in the U.S. The DRI Federation is also working with the international non-profit Cure Focus Research Alliance  to further its research, even beyond diabetes into how this mini-organ could be used in other conditions like cancer and Crohn's Disease.

Even if this research pans out, would it constitute a cure, or are false hopes being raised here? That may depend on whom you ask, but even Ricordi notes that the definition of a "cure" is subjective. While the BioHub could reverse type 1, much research remains on learning the reason for the underlying immune system attack and preventing that from happening. Again, as Ricordi says, "it's all part of a bigger puzzle."

A few in our D-Community are very excited about this news... including D-Dad Tom Karlya, who is vice president of the DRI in addition to having a son and daughter both living with type 1. He writes on his blog: "It is the most exciting thing I have heard since the day Kaitlyn was diagnosed over 20 years ago. It is not pie-in-the-sky; it is not broken promises; it is real......very, very real."

Yet some wonder if all the aggressive hype about this research to countless families isn't more of a fundraising campaign for the DRI than anything else.  A five-minute video that went live at midnight last night ends with a blatant plea for money and tells viewers "what happens next depends on you." This push angered many in the DOC.

"We are always cautious not to raise false hope and hype about a potential cure, but we continue to work with the intensity, the concentration and the relentless effort like the next trial could be the one," Ricordi responds. "Progress and momentum have never been so promising, and I have been optimistic before, but I will continue to move with the same degree of enthusiasm as I was 10 or 5 years ago. To me, someone who thinks that a cure could be further than 5-7 years from now should work on something else, maybe a mouse model of diabetes research. I maintain my optimism and determination not to stop, and to keep the focus of our efforts on the cure."

Well, you have to credit Ricordi and the DRI for keeping the faith, even despite past shortfalls and donor skepticism about how they've been working toward a biological cure. Personally, I think it's always encouraging to see so much parallel research happening worldwide on many fronts, between different researchers and organizations. That just brings us closer to finding something that will take us toward a true cure, no?

So as always, we remain cautiously optimistic whenever we hear these announcements about a concept that may or may not be a "quantum leap." If that turns out to be the case, naturally we'll be celebrating along with everyone else. But the proof is in the pudding. In the meantime, we're keeping our faith in the technology that we see playing a big part in helping us stay healthy in the here and now.

 

 

** UPDATE: March 9, 5:20pm **

 

 

Dr. Ricordi has since posted a Q&A on his Facebook page, where he answered a handful of questions about the DRI BioHub, including several questions worded exactly as those we posed to him for our coverage here at the 'Mine leading up to the announcement. And on March 15, 2013, the DRI's Dr. Luca Inverardi will be doing a live interview on TuDiabetes from 1-2 pm PST.

 
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