Marc Hedrick Testimony: Senate Commerce Subcommittee on Science, Technology and Space

Date: 09/29/2004

Marc H. Hedrick, M.D.

President, MacroPore Biosurgery;
Surgeon, University of California at Los Angeles

Mr. Chairman, Distinguished Members of Committee, I would like to thank you for the opportunity to be here today.

I have been fortunate to have been involved on the front lines of the stem cell issue for some time. As a surgeon at UCLA, I saw first hand the need for stem cell treatments in my patients. As a researcher, I received NIH funding to study adult stem cells at our program at UCLA. And now I serve as President of MacroPore Biosurgery, a public company from San Diego, California. Our company is dedicated to developing adult stem cell therapies to help as many people as we can. Based on this experience, I feel I can say to you in the strongest possible terms, we truly are on the edge of a new frontier in medicine.

Over the past two years, our company, has made a strategic decision to take a leadership role in developing adult stem cell therapies. This decision was based both on our excitement for the technology and our vision for what it could ultimately do for patients. If I may, permit to quote from the NIH website,

“…given the enormous promise of stem cells to the development of new therapies for the most devastating diseases, when a readily available source of stem cells is identified, it is not too unrealistic to say that this research will revolutionize the practice of medicine and improve the quality and length of life.”

And that is absolutely is our goal.

We agree with the NIH that cell availability has been a significant challenge not only for the clinical, but for the commercial application of stem cells. Stem cells have been thought to be rare, difficult to obtain, often requiring long periods of cell culture or multiplication.

But today, we have found a potential solution to the significant challenge of cell availability. We believe the solution is the use of fat or adipose tissue, as a source of stem cells.

This is a low cost, high volume alternative to other stem cell sources. This technology enables us to rethink how patients may be treated using their own stem cells. This is an important breakthrough for adult stem cell therapies.

From adipose, we can obtain at least two of the key types of adult stem cells that can potentially treat many diseases such as:

heart disease;

stroke;

injured bones and joints;

degenerative spinal disease; and

vascular diseases.

 

The first adult stem cells were identified about 40 years ago in bone marrow. Since then, bone marrow transplants have been used to treat many diseases, specifically blood diseases and cancer.

And until recently, bone marrow was thought to be the only significant clinical reservoir of adult stem cells.

But even this source yields a relatively limited number of cells. So how does adipose measure up as a stem cell source? Well, one cup of adipose tissue can yield approximately 1 million stem cells. This is about 100x more stem cells found in the same amount of bone marrow.

Let me use myself as an example:

I am six feet, one inch tall;

my weight is 180 pounds;

and fifteen percent of my body weight is adipose.

 

So I have 27 pounds of fat on me, which represents over 6 billion adult stem cells.

What does this mean? It means opportunities-opportunities for your own body to potentially heal itself with its own cells, not within days or weeks but within an hour. What we are talking about here is ‘real-time’ stem cell therapy.

This real-time approach is not just conceptual. This week, at a cardiology meeting in Washington, D.C., our Company along with our collaborators at UCLA and Cedars Sinai, reported that adipose derived stem cells are safe and improve heart function after heart attacks. We used pigs in this study because they are predictive of future success in the treatment of human heart attacks.

Heart disease is becoming the most promising emerging area for the use of stem cell therapy. In 15 years, cardiovascular disease will be the principle cause of death worldwide. Over 1 million Americans each year have a heart attack and another 6 million have significant heart failure. Sadly though, that means that one out of every three people in this room will die of cardiovascular disease.

It’s a staggering thought. MacroPore is addressing this clinical need by developing a unique system that enables doctors to treat patients with their own stem cells from adipose tissue.

If successful, this system will fundamentally change the state of the art for heart attack treatment. It will enable us to move from supportive care-which is what we do now-to regenerative therapy.

Both our research and that of others indicates that adult stem cells can do 3 important things for the ailing heart:

make new heart cells,

make new blood vessels,

and rescue dying heart muscle.

 

While the science is complex, for the doctor and patient, the procedure represents a simple way to help heal the heart.

Seven clinical studies, mostly clinician initiated, are now in progress around the world to study adult stem cells for cardiovascular disease. The early results are promising.

For example, follow up data just presented from the joint Texas Heart Institute and Brazilian heart failure/stem cell human trial noted that four out of five patients being studied were no longer in need of a heart transplant after being treated with adult marrow stem cells.

But despite all the clinical success of adult stem cells, misconceptions are still commonplace. For example, in a recent study of Americans who claim to be knowledgeable about stem cells, Sixty-eight percent thought that adult stem cells come from embryos. Other misconceptions are more subtle. Some think that adult stem cells are too rare, don’t multiply well enough, or are too limited in their potency to ever be useful. But all of these misconceptions are just that, they are not factually correct.

The truth is that both bone marrow and adipose tissue are plentiful and clinically promising sources of adult stem cells. They grow well and have the ability to make and repair many tissue types throughout the body.

We often make the mistake of referring to the promise of stem cells as if it’s a future event. In fact, this ‘promise’ has become a reality. The list of successful therapies using adult stem cell grows each year, as does the list of patients helped. While there is still a lot of work to be done, I would humbly remind you that, in many cases, the promise is already being realized.

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