Stem Cell Companies pursue Regenerative Medicine

North County Times – 35 companies and researchers spoke at last week’s stem cell conference in La Jolla.

Nearly all of them shared the goal of using stem cells and the body’s own regenerative ability to treat diseases and injuries. But their approaches to regenerative medicine vary greatly.

Many are tackling diseases such as diabetes, cardiovascular disease and hair regeneration. Some aim to provide new and useful stem cell types. Others provide equipment to expand regenerative medicine’s tool chest.

Here are summaries of five of the presentations:

Aderans Research Institute: Your own hair, back again. That’s the allure of Atlanta-based Aderans’ Ji Gami hair growth process. Patients donate hair-containing skin from their neck, and Aderans cultivates the hair follicle-forming cells. These cells are then injected back into the patient.

The cells stimulate new hair production in dormant hair follicles, working on male or female pattern baldness, said Aderans Chief Executive Ken Washenik. They have been tested in animals and are now being tested in people.

“When we inject this mixture of dermal and epidermal cells … we find that the cells intercalate (integrate) into existing hair follicle structures and reprogram them or turn them back on,” Washenik said at his company’s presentation.

Aderans has performed Phase 1 safety studies on Ji Gami, and has now started Phase 2 studies, looking for effectiveness.

DiscGenics: About 30 million Americans experience lower back pain, much of it caused by spinal disc degeneration. The market for treating it is about $4.4 billion, said Flagg Flanagan, president and CEO of DiscGenics, based in Salt Lake City.

DiscGenics proposes to reverse disc degeneration with “adult” stem cells taken from spinal discs. The company has developed a technology to isolate these cells, receiving a patent for it in June.

Injury or aging-related changes to the disc cause it to lose flexibility and alter its composition, so it doesn’t properly cushion the vertebrae. DiscGenics’ goal is to reverse this process by injecting disc stem cells along with other healing-promoting materials. The stem cells will be taken from another person and grown in a lab, Flanagan said.

The regenerative power of these cells has been demonstrated in studies in rabbits, Flanagan said. More studies will follow in rabbits, then pigs, and then in people. The company expects to get its treatment to market in 2017, he said.

Eqalix: Imagine a replacement skin covering for wounds or ulcers that causes no immune reaction and has an unlimited shelf life. That’s what Reston, Va.-based Eqalix offers, says its CEO, Joseph Connell.

The company licensed technology from the University of Pennsylvania, Drexel University and Children’s Hospital of Philadelphia to make the skin from soybean protein. The protein creates a scaffold that guides skin cell regrowth, inhibiting scar formation, Connell said. It can also be molded to create very small blood vessels that actually work, he said. These properties have been tested in animal studies.

“No one in our industry can make a small-diameter vessel that doesn’t occlude,” he said.

Using soy as a source brings down the cost far below that of other temporary skin coverings, such as those grown from porcine or human cadaver sources, Connell said. It also doesn’t cause allergic reactions.

“My vision is to have this available for our armed servicemen in battle,” he said. “It will also be available for wound-healing and for burns.”

Eqalix seeks partners to take its product, called OmegaSkin, through clinical trials to prove its effectiveness.

MediStem: Ischemia — the lack of blood flow — produces heart pain and actual heart attacks. When ischemia takes place in limbs, they may require amputation. To restore blood circulation before it’s too late, San Diego-based MediStem is testing a special type of stem cell to make new and sturdy blood vessels.

These cells, called endometrial regenerative cells, are derived from menstrual blood. They don’t cause an allergic reaction so they’re not rejected, said Alan Lewis, the company’s CEO.

“We call them nature’s regenerative powerhouse,” Lewis said. The cells reproduce prolifically and are very good at creating new blood vessels. The U.S. Food and Drug Administration has approved their use for clinical trials.

“It’s a very efficient way of generating cells,” Lewis said. “One donor can generate as many as 20,000 doses of cells. They’re pretty sturdy cells. They can be frozen. They can be sent across country, around the world, as a point-of-care product.”

MediStem is now conducting clinical trials with these cells to promote blood vessel growth in patients with critical limb ischemia and also in patients with heart failure.

Capricor: Heart failure is the long-term, progressive inability of the heart to keep up with the demands placed on it, often occurring as the result of a heart attack. Beverly Hills-based Capricor is trying to stop that process with cardiac stem cells.

Severe heart attacks result in the formation of scar tissue, which reduces the heart’s capacity. Capricor’s cardiac stem cells have been shown in early human clinical studies to inhibit scarring after heart attacks and replace damaged tissue with healthy, beating muscle, said CEO Linda Marban.

Capricor’s studies were conducted at Cedars-Sinai Medical Center and Johns Hopkins Hospital. A new study is now under way.

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