Written by ι Stock Market Media Group Staff — April 18, 2013
Nuvilex, Inc. (OTCQB: NVLX) has “Cell-in-a-Box,” the Diabetes Research Institute has BioHub. One is cell encapsulation technology, and the other is an integrated spongy wafer. While they have different names and a different structure, the idea is the same – building a fully protected home to house pancreatic islet (insulin-producing) cells for transplantation into diabetics.
Both Nuvilex and the Diabetes Research Institute (DRI) have identified the problem and clearly have a game plan in place to address it. Between “Cell-in-a-Box” and BioHub there is real hope on the horizon for diabetics who currently engage in a daily routine of checking their blood-glucose levels many times, giving themselves insulin either through injections or with an insulin pump, watching what they eat, monitoring how much or how little exercise they’re getting and the list goes on and on. While the islet cells in a diabetic’s pancreas no longer sense glucose and therefore the pancreas doesn’t produce insulin, the pump or self injections provide the body with the insulin needed to stay healthy.
Well, help is on the way! Whether it will be Nuvilex’s “Cell-in-a-Box” or the DRI’s BioHub or both, the many scientists working to offer what Nuvilex calls a type of “artificial pancreas” and DRI calls a “mini-organ” are on the right track with their similar approaches to the same problem. Islet cell transplantation is nothing new, but long term housing of the cells is the goal. The director of the DRI, Dr. Camillo Ricordi, says for his organization’s BioHub to be successful, the structure must prove it “restores natural insulin production and normalizes blood sugar levels without imposing other risks.”
Groundbreaking work in a high profile study called the “Edmonton Protocol” showed that pancreatic islet cell transplantations could hold the key to a game-changing diabetes therapy. However, the problem in that study was that because the cells were derived from “foreign” donors, the patients would require heavy doses of expensive and potent immunosuppressive drugs for the rest of their lives to stop their immune systems from attacking and destroying the transplanted islet cells.
Nuvilex and the DRI figure one way to prevent attack by the diabetics’ immune systems on the transplanted islet cells could be to house the cells in a structure that can protect them from such attacks. In turn, this could make the use of immunosuppressive drugs unnecessary. Nuvilex knows it can already accomplish this because in the company’s mid-phase pancreatic cancer clinical trials, living cells encapsulated using their “Cell-in-a-Box” technology were protected from immune system damage for more than 2 years, without the use of immunosuppressive drugs, and were alive and well after all of that time. DRI is still addressing the need to use immunosuppressive drugs.
Nuvilex’s cell encapsulation technology uses living cells, and the company takes a very specific type of cell to address a specific problem a patient suffers from. Scientists then fully enclose the cells in unique “capsules” made mainly of cellulose, forming essentially “cotton bags” with live cells inside. The capsules are about the size of the head of a pin. The capsules have “pores” in them that allow nutrients for the cells inside to enter and waste products and “beneficial” factors produced by the encapsulated cells to leave. Each bundle of encapsulated cells becomes much like a miniature cell factory with the ability to produce whatever is needed—in this case insulin.
This basic cell encapsulation process can serve as a “platform” upon which treatments for many serious, debilitating, and even fatal diseases may be built. Some of these diseases include different types of cancer, diabetes, diseases for which stem cell therapies are being developed, and diseases caused by viruses.
Unlike Nuvilex’s fully enclosed capsules, the Diabetes Research Institute’s BioHub is made up of a different type of structure altogether. It’s a flexible, sponge-like scaffold platform resembling a wafer about the size of a quarter. The BioHub, like “Cell-in-a-Box,” is highly porous and can house thousands of islet cells of different shapes and sizes. In the BioHub, the cells lodge within the pores just as clusters of islets would inside the pancreas. Scientists at the DRI have discussed implanting the “mini-organ” in the omentum, a fold of the tissue lining the abdomen that surrounds the organs, where blood and nutrients can reach the islets, and allow them to thrive.
So far in Nuvilex’s animal studies, the company has essentially been able to develop a type of “artificial pancreas” that controls blood sugar levels and eliminates the need for insulin treatment. In a 6-month study, pancreatic islet cells from pigs were encapsulated using the company’s technology and the capsules containing the islet cells were then implanted into live, diabetic rats. Within only a few days, the blood sugar levels of the rats became normal and stayed at normal levels for the duration of the study.
When the capsules were removed from the rats at the end of the study, the islet cells inside the capsules were still alive and functioning. Pigs were chosen as the source for the pancreatic islet cells because biologically they are the closest to humans. Because islet cells from pigs (“foreign” donors) could be implanted in rats without the cells being rejected, this proves the islet cells inside Nuvilex’s capsules were protected from attack by the rats’ immune systems. This has the potential to answer a lot of the concerns that the diabetes research community is addressing including the Diabetes Research Institute. Whereas the supply of deceased organ donors (human cadavers) is far outnumbered by the number of diabetics, there is certainly a large supply of pigs to harvest islet cells from in an attempt to find a biologically similar source to draw from for transplantation.
Nuvilex is now making plans, in conjunction with a national diabetes foundation, to repeat these studies on a larger scale, and if successful, the expanded animal studies could lead to clinical trials in humans.
Meanwhile, Dr. Ricordi said the DRI is already engaged in preliminary testing of its “mini-organ,” with larger scale testing to come. “We will begin to test elements of the BioHub in humans within one to two years.”
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