Once stem cell-based organ replacement becomes a reality, it is going to make an enormous dent in some of our largest health care problems. It will mint numerous new millionaires in the process. Here’s a preview of the next emergent healthcare technology that could do just that…

The top cause of death in the United States is heart disease. More than 600,000 people die of heart disease in the U.S. alone. More than 1 million people suffer a heart attack. Worldwide, the number swells to 22 million. For the survivors, living with a damaged heart becomes their day-to-day reality. For those needing heart transplants, the waiting lists are long. Even when a recipient does receive a transplant, it is from a foreign donor, and a lifelong course of immunosuppressant therapy is needed so that they do not reject the organ. The health care costs associated with heart disease are vast.

Although heart cells are grown in culture and even made to beat, the heart is much more than a mere collection of cells. It has a complex structure that needs to be recreated in order for a whole, transplantable organ to be possible. Within the heart itself, there are different types of cells. Any kind of attempt at regrowing a heart will need to place the right kinds of cells in their correct locations within the organ.

This seems like an insurmountable problem, but a recent breakthrough based on research carried out by Doris Taylor and Harald Ott while working at the University of Minnesota is making it possible. They have found a way to create a complete structure to which stem cells can attach and grow into a working heart. When it comes to science and the human heart, there are no limits.

Plumbing for a Solution

The Minnesota researchers theorized that if a heart could somehow be reduced to its basic skeleton, it could then be used to create the framework for growing a new one. In order to do this, all the old cells would have to be removed while leaving behind the extracellular matrix (ECM). This matrix consists of the protein fibers that form the scaffolding that gives the body’s organs their shape and structure.

Decellularization techniques have been around for a long time. Existing methods immerse the organ in a solution containing a detergent. The detergent, in turn, reacts with the cells, in effect “scrubbing” the protein skeleton clean of cells from the outside in.

The problem with existing decellularization methods is that the protein scaffolding also takes some damage. The protein matrix not only provides the structure for the tissue, it also contains important biochemical markers that tell growing cells where they are in the organ and what they are supposed to be doing. Without the signals provided by these markers, called cytokines, stem cells do not reliably differentiate into the right kind of tissue in an extracellular matrix. In addition, stem cells seeded into this matrix to regrow the organ do not always end up close enough to food and oxygen to survive and multiply into new tissue.

In order to address this problem, Drs. Taylor and Ott invented a completely new method of stripping cells away from the protein skeleton called profusion decellularization. Instead of merely immersing an organ in a solution, they connected the blood vessels to pumps that circulated detergent solution throughout the entire organ’s blood supply. This keystone technology allows the vascular plumbing of the organ to act as a conduit to clean out the organ from the inside. It provides a far superior environment for stem cell seeding where the new cells are able to receive the nutrients and oxygen they need to proliferate and differentiate.

Following Their Heart

These findings were published in the prestigious peer-reviewed scientific journal Nature Medicine. The discovery won Popular Science’s award for best health innovation of 2008. Additionally, after acquiring full licensing for the technology from the University of Minnesota, the discovery provided the key technology for a new startup: Miromatrix Medical Inc.

Currently, Miromatrix is a very-early-stage company seeking additional private funding to continue developing the technology to realize its ultimate goal of whole organ regeneration. However, Miromatrix has a stepwise business plan for bringing new heart products onto the market in the next few years.

The first iteration of the technology will consist of a cardiac patch derived from decellularized pig hearts. Porcine ECMs are similar enough to those in humans to be useful in therapies. In order to simplify the FDA approval process for the first version, the patch itself will not be recellularized, but will be the protein matrix alone. When grafted into tissue damaged by a heart attack, it will provide the framework for the patient’s own stem cells to migrate, attach and regrow.

The second-stage product will be partially recellularized. In this version, the blood vessels in the patch will be regrown with endothelial stem cells. The final version of the patch will be fully populated with new heart cells for transplant. Miromatrix expects the first product to be available in three years.

Since Miromatrix is still a private company, we cannot add it to our portfolios, but I am watching it very closely and hope to do so in the future.

For transformational profits,
Patrick Cox
Penny Sleuth

August 4, 2010

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• May 13, 2010 -- Making Sense of Stem Cell Investments: An Update

Patrick Cox

Patrick Cox has lived deep inside the world of transformative technologies for over 25 years. In the 1980s, he worked in computer software development and manufacturing. By the mid-1990s, he worked as a consultant for Netscape — the company that handled 90% of all Internet browsing traffic at the time. InfoWorld and USA Today have featured Patrick's research numerous times. He's also appeared on Crossfire and Nightline. Patrick has been quoted by The Wall Street Journal and Reason magazine. His expertise brought him to Agora Financial, where he now heads Breakthrough Technology Alert, the only place you'll find the truly transformational technologies that offer exponential gains.

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