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Nuvilex, Inc. Cell-in-a-Box Technology Could Revitalize the Stem Cell Phenomenon

Nuvilex, Inc. Cell-in-a-Box Technology Could Revitalize the Stem Cell Phenomenon

Written by ι Stock Market Media Staff — March 12, 2013

Remember not so long ago when every science related conversation seemed to weave its way into a conversation about stem cells?  Back around 2007, there was a real phenomenon going on among biotechnology companies that had anything at all to do with stem cells, and now six years later with more research in the books, that enthusiasm has waned a bit.

Still, stem cell treatments are being developed for many ailments including arthritis, “joint” injuries, neurologic diseases such as Parkinson’s, Alzheimer’s, ALS (Lou Gehrig’s disease), dementia, and even wound repair, among a host of others.  However, progress with the development of stem cell-based therapies has been tempered somewhat, largely because of the characteristics of the stem cells themselves.

The way the process is supposed to work is that stem cells or other therapeutic cells are implanted or injected into a patient’s body to enable the cells’ therapeutic action.  This therapeutic action can be achieved by the cells producing a “beneficial” healing factor, or by “signaling” to other cells and stimulating healing.

Clear the Hurdles – Reignite the Phenomenon

However, industry leaders have consistently found a number of hurdles limiting the success of stem cell treatments including; immune system attacks on the transplanted cells, migration of the cells after transplantation, formation of abnormal growths (including tumors) after such migration, problems with long-term storage of the cells for later use, and problems with the use of the cells inside bioreactors.

With recent estimates predicting that the global market for stem cells and stem cell products will reach nearly $6.6-billion by 2016, the research continues.  Companies like StemCells, Inc. (NASDAQ: STEM), BioTime, Inc. (NYSE: BTX), Aastrom Biosciences, Inc. (NASDAQ: ASTM), International Stem Cell Corp. (OTCQB: ISCO) and Advanced Cell Technology (OTCQB: ACTC) are hard at work in the sector trying to solve the roadblocks that keep the FDA from approving any stem cell treatment to date.     

Meanwhile, Nuvilex, Inc. (OTCQB: NVLX), an international biotech headquartered in Silver Spring, Maryland, is currently in negotiations with biotechnology and pharmaceutical entities that wish to examine the employment of Nuvilex’s living cell encapsulation technology, or Cell-in-a-Box™,  in the development of treatments for various diseases that would utilize stem cells.

What is Nuvilex’s Cell-in-a-Box?  Could this living cell encapsulation technology be the silver bullet to get many stem cell companies through some of the roadblocks that have plagued their success?

Understand the Science – Understand the Benefits

Nuvilex’s “Cell-in-a-Box” 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 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.

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.    

Why are companies that work with stem cells interested in this technology?

Well, for starters, the development of treatments for many diseases using stem cells has been problematic because, when unencapsulated stem cells are transplanted, about 50% of these transplantations are destined to fail.  Among the issues plaguing the science are immune system attacks on the stem cells and the stem cells migrating to other parts of the body after being transplanted, making them less effective and, in some cases, resulting in their forming “abnormal” growths, including tumors. 

A few highlights of Nuvilex’s Cell-in-a-Box technology include:

•  Encapsulation of stem cells with the Cell-in-a-Box technology protects the cells from attack by the body’s immune system — the “pores” of the capsules are too small for immune system cells to get inside and destroy the cells within the capsules and are too small to allow the encapsulated cells to leave the capsules.

•  Due to the size of Cell-in-a-Box capsules, many cells can easily be fixed in one location. Capsules can be infused, injected or implanted into almost any tissue, organ or location in the body.

•  The Cell-in-a-Box capsule material is biologically inert, meaning that it doesn’t cause any immune reaction or inflammation at the site of capsule implantation, in the tissues that are near the capsules.

•  Once the cells have done their job, the Cell-in-a-Box capsules can be removed, if necessary… depending on implantation location.

•  By being safely enclosed in the Cell-in-a-Box capsules, the cells cannot “migrate” to distant locations within the body and form abnormal growths in those places.

The belief that Nuvilex’s cell encapsulation process protects the cells inside the capsules from migrating to distant sites within the body and from immune system attacks comes from the company’s two independent trials in advanced pancreatic cancer.  Here, not only did encapsulated cells remain where they were implanted, but also, they were not attacked by the patient’s immune systems; thus, surviving and functioning for more than 2 years inside the body without stimulating immune responses towards them.

Because Nuvilex’s technology would keep stem cells at the location in which they are implanted, the cells would be able to secrete “beneficial” factors that are released from the capsules right where they were needed– while the stem cells remain inside the capsules.  This property alone could result in the encapsulated cells performing their desired functions with more efficiency than if they were not encapsulated.

Again, Nuvilex’s encapsulation of stem cells can greatly reduce the chance of the formation of abnormal growths at sites distant from the site of implantation – encapsulated stem cells do not escape from the capsules.

Additional areas where companies might benefit by using Nuvilex’s cell encapsulation technology include long-term cell storage and in bioreactors. 

Stem cells encapsulated using Cell-in-a-Box can be frozen and stored for long periods of time without being damaged.  This has been somewhat problematic for other forms of encapsulation.  Because cells, like other biologic materials, are often shipped over long distances for various uses, it is often advisable that they be shipped in a frozen state; this property of Nuvilex’s technology would allow for successful transport of stem cells over long distances without damage.

Additionally, large biotech and pharmaceutical companies like Genentech, Amgen Inc. (NASDAQ: AMGN), Merck & Co., Inc. (NYSE: MRK), Pfizer, Inc. (NYSE: PFE), etc. might benefit from the advantages of using the Cell-in-a-Box technology in bioreactors.  Bioreactors are large (often 10,000 to 20,000 liters or more) vessels (usually stainless steel) in which some medicines and drugs and industrial biomolecules such as antibodies, therapeutic proteins and enzymes are made.  In some cases, like with stem cells, the cells themselves are the product – in others they are a step in the production process.

In a perfect world, cells in bioreactors will be able to perform their desired function with a 100% rate of success.  However, due to the design of the systems, the cells inside the bioreactor are often damaged because of the stirring and agitation that is necessary within the bioreactor.  These processes impose stresses on the cells that can cause the cells to have inhibited growth and/or biomolecule production.  In addition, these stresses may limit the types of cells that can be used, the types of products that can be made, and the overall efficiency of the production processes themselves.

Scientists at Nuvilex feel their cell encapsulation process may optimize the use of stem cells, as well as other types of cells, in bioreactors by protecting them from the aforementioned damage.  The Cell-in-a-Box technology might protect the cells sufficiently to allow them to grow and be more productive in the bioreactors.  This broadens the scope dramatically for bioproduction from cells, and at the same time, may allow cell types that are too fragile for conventional bioreactors to be used.

For those investing in the stem cell sector, any solution that can help generate the energy and the phenomenon felt six years ago is welcomed.  And, if at the same time, that solution can help bring some long-awaited successes to many companies in the sector, stem cells might finally get the “thumbs up” from the FDA and quite possibly approvals of stem cell-based treatments might occur one right after the other.

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