Stem cells from fat

Getting rid of that spare tire around your middle could help your heart in more ways than you might expect, according to a San Diego biotechnology company.   Cytori Therapeutics has developed a machine that pulls stem cells and other regenerative cells out of fat so they can be re-injected into the body to repair tissue damaged by heart attack or disease.

Several studies, including some in which Cytori scientists have participated, have shown that stem cells and other regenerative material from fat can help build blood supply and restore blood flow to cardiac muscle that has been damaged by a heart attack.   Scientists are also looking at stem cells from bone marrow and umbilical cord blood, but Cytori thinks the money is in the fat. The company wants to be one of the first to commercialize the use of stem cells from fat and bring new therapies to patients.

“There are broad markets for our platform technology,” Chief Executive Christopher Calhoun said. “Stem cells work in a variety of ways and are going to work for treating a variety of conditions, by turning into muscle or bone or cartilage. And that on its own creates a lot of different opportunities.”   Last month, the company gained European regulatory approval to begin using its machine, called the Celution System, in clinical trials on humans. Cytori plans to begin using the system in clinical trials outside the United States in applications on the heart, said Dr. Alex Milstein, vice president of clinical development.

It's also planning to begin studies in Japan using fat-derived stem cells in reconstructive surgery. Meanwhile, the company is pursuing U.S. regulatory approval for its system as a medical device. If the company can clear that hurdle, its plan is to begin clinical trials in the United States, using the fat-derived stem cells in cardiac applications, spinal disc regeneration, gastrointestinal disorders and peripheral vascular disease, Milstein said.

The magic of stem cells is that they are the building blocks of the different types of tissue in the body.

Cytori deals with what are known as “adult” stem cells, which are programmed to become a specific cell type: bone, blood, nerve or tissue. Studies have shown that adult stem cells sit within reservoirs in fat, bone and blood until they are called upon to repair a broken bone or damaged tissue.

They are different from embryonic stem cells, which are formed just days after conception and develop into the many different cell types in our bodies. Embryonic stem cell research has been controversial because it requires the destruction of embryos, which some people believe are lives that should be protected.

Each type of stem cell is showing scientists that it has its own unique qualities. And each requires different methods for retrieval. Only a small amount of stem cells can be pulled from bone marrow, Milstein said. To create a sufficient amount for therapy, the marrow must be sent to a lab where it is used to grow more cells. This process, called culturing, can take two to four weeks. It's expensive – estimated to cost about $30,000 – and requires the patient to make a second visit to the doctor to receive the therapy, Milstein said.

Cytori focuses solely on retrieving its stem cells from fat, which is more plentiful, easier to retrieve and therefore less expensive, Milstein said.

“Most people, including myself, have fat they wouldn't mind getting rid of around their waist . . . or their love handles,” Milstein said. But even thin people have enough fat to provide stem cells, he said.

Cytori didn't start out obsessed with fat. The company was founded in 1996 as MacroPore Biosurgery and focused on orthopedic implants, which it still sells. The company went public in 2000, trading on the Frankfurt stock exchange. Two years later, founder Calhoun met UCLA professor Marc Hedrick, who first discovered stem cells in fat. Hedrick had founded StemSource.   In 2002, the companies merged and Hedrick became president. Last year, MacroPore changed its name to Cytori and began trading on the Nasdaq, where shares sold yesterday at $7, giving the company a total stock value of $106.7 million. For the first nine months of last year, the company reported losses of $12.2 million on revenue of $4.9 million.

As of the end of the third quarter 2005, the company employed 130 and had $10 million in cash and cash equivalents. In November, it received $11 million by entering a collaboration with Olympus. And earlier this week it reported it received an $11 million milestone payment from Olympus for receiving European regulatory approval. Some Californians are making nonmonetary donations to Cytori every week. The company receives liters of raw material from people who agree to allow the fat removed from their bodies during liposuction be used in research.

The pinkish-orange fat tissue is first transferred into a small centrifuge containing enzymes that help digest it, separating the yellow-tinged fat cells from pink regenerative cells that include stem cells, collagen and other tissue scaffolding. The desired regenerative cells are then skimmed off and placed in a larger centrifuge, which goes through a relatively quiet spin cycle to rinse the cells with a saline solution and further separate the stem cells from other cellular material. The final product is the color of pink lemonade.

The stem cells in about one cup of fat can generate what Cytori currently considers to be a therapeutic dose, Milstein said. The average liposuction procedure for cosmetic purposes provides about one liter, he said. The system would allow a doctor to remove a small quantity of fat from a patient and process out the stem cells and regenerative cells within an hour, so that they could be injected into the patient in real time, he said.

Giving the patient his own stem cells as a therapy should avoid THE issue of rejection by the autoimmune system, he said.

Since Cytori is not manipulating the cells in any way, and the machine would be used to inject patients' own stem cells back into them, the company hopes regulators will consider it a medical device. That would require a much faster and less-complicated approval process than for the approval of drugs or therapies.

The company envisions that its final system, which the Japanese company Olympus is helping Cytori refine, would be placed in a hospital surgery suite or catheter lab. As a doctor is snaking a catheter into a patient's heart, the machine could be separating the stem cells from fat for injection when the doctor is ready. Making the system affordable is the key to grabbing investor interest, said Stephen Dunn, an analyst with Dawson James Securities in Boca Raton, Fla. Stem cell therapy is considered personalized medicine, meaning therapies are tailored to individual patients' needs and genetics. Investors have objections to putting their money behind personalized medicine because typically therapies are thought to cost about $30,000, Dunn said.

“To be commercially viable, and reach the point where insurance might cover it, the cost to the hospital or doctor needs to be about $5,000 or less,” he said. Adult stem cell therapies, such as the one Cytori is pursuing, seem to be in that range, he said. Good clinical data would also help an unknown company such as Cytori get on investors' radar, Dunn said.

“The issue now is for Cytori to go through the steps to collect that data, showing its system can be used in effective and safe therapy,” he said. “My job is to professionally handicap biological technologies, and Cytori looks pretty good. So far I haven't seen any red flags.” Even if the therapy appears to work, there could be other questions.   As a cardiologist, stem cell researcher Dr. Judy Swain would like to see the company collect data showing that the restorative effects of the therapy for heart ailments is a result of the stem cells and not the other matter, like growth factor, in the space between the cells.

“I'd like to see them label the cells that are injected and show whether the cells stay where they are injected,” said Swain, who is UC San Diego's dean of translational medicine. “Do they divide? Do you get more? Are they in sync with the other electrical impulses in the heart muscle?” Just saying someone feels better is not good enough, she said. “Most other tissue and organs, you can put extra cells in and if they are not doing any good, at least they won't do anything bad. With the heart, those extra cells have the potential to do something bad electrically,” Swain said.

Cytori executives say they do not know if the fat-derived stem cells alone are responsible for the restorative results shown in animal studies. Once the company passes its regulatory hurdles, Calhoun said, studies on the efficacy of the therapy and characterizing the cells functions are priorities they will tackle with collaborators.
If the stem cell business takes off, Cytori already has a secondary business up and running: a stem cell bank. “We're really not marketing it right now,” Calhoun said. “But younger fat appears to be much richer in stem cells.” People could have their stem cells harvested early, he said, bank them and rest easier knowing they are there should they be needed.

Healtheuniverse Develops Technology to Create Non-Embryonic Adult Stem Cells From Fat

Company Positioned to Perform First Human Clinical Trials Using Proprietary Stem Cell Technology

COVINA, CA -- (MARKET WIRE) -- 02/14/2006 --

Healtheuniverse Inc. (OTC: HLUN), a diversified biotechnology development firm specializing in the development and commercialization of patented biopharmaceutical and biomedical products, announced today that its research has developed technology to create adult stem cells using fat. Scientific protocols are being prepared for the first human clinical trials using the company's proprietary stem cell technology. This technology uses adipose tissue, or fat which can be used as an abundant source of stem cells for tissue engineering and regenerative medicine. The Company intends to sell this proprietary technology to physicians, clinicians and medical organizations through a packaged product line and licensing agreements within the worldwide regenerative medicine market which is estimated to grow to $500 billion by 2010.

Fat cells are abundant in human beings of all ages and are easily accessible. Research demonstrates that up to 50 million potential stem cells can be derived from a pound of fat. The fat can be harvested confidently, consistently, and most of all safely from any individual from any age. Fat tissue contains stem cells, and research suggests they can be coaxed into other cell types, such as nerve, bone, muscle and blood vessels.

"We believe there are currently no human trials in the United States evaluating the potential of stem cells derived from fat and we are moving toward being the first," stated Dr. Vipul Dev M.D., Chief Executive Officer of Healtheuniverse, Inc. "Our technology is focused on developing therapies using patients' own cells, as opposed to cells that might be donated by other individuals. Because fat is both abundantly available and easily accessible, it offers a practical source of stem cells. Just about everybody, even slender people, carries enough fat to yield a good supply of cells for their own treatment. Fat produces so many stem cells that there's no time-consuming need to grow more of them in the lab."

About HEALTHeUNIVERSE Inc.

HEALTHeUNIVERSE Inc. is a biotechnology development firm specializing in the development and commercialization of patented Biopharmaceutical and Biomedical products. We are engaged in research and development of regenerative medicine therapies using non-embryonic adult stem cells for use in plastic, reconstructive, orthopedic, vascular, and cardiac surgery. Healtheuniverse strives to be the first to commercialize the use of regenerative medicine in plastic and reconstructive surgery and to develop therapeutic uses in the most profitable commercial applications. More information on Healtheuniverse is available online at http://healtheuniverse.com/.

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.