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3 UW spinoffs form major stem cell company

By RYAN J. FOLEY | Associated Press Writer

MADISON, Wis. – Three companies founded by star University of Wisconsin-Madison stem cell researcher James Thomson are merging into a single entity that aspires to be a world leader in the field.

Under a deal announced Monday, Cellular Dynamics International is joining forces with Stem Cell Products Inc. and iPS Cells Inc. Backed by $18 million in private venture capital, the new company is keeping CDI’s name and its headquarters in Madison.

“The new company has an ambitious goal: it intends to be the world leader in the industrialization of basic stem cell technology,” said Bob Palay, its chairman and chief executive.

Thomson said the company would focus first on supplying human heart cells made from stem cells to pharmaceutical companies for drug testing. He has long predicted stem cells would be most useful first in speeding drugs to market and pinpointing potential side effects.

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Stem Cells Spawn First Drug-Free Windpipe Transplant

By Michelle Fay Cortez
Nov. 19 (Bloomberg) — Doctors operating on a 30-year-old Colombian woman restored her ability to breathe freely with the world’s first transplanted windpipe specially treated to prevent organ rejection.

The airway connecting Claudia Castillo Sanchez’s left lung to her windpipe collapsed after a persistent tuberculosis infection, leaving her short of breath and unable to perform routine daily activities. Efforts to prop it open failed, leaving Spanish doctors two options: remove the lung or replace the airway using an experimental technique tried only in animals.

The donor windpipe, or trachea, was washed 25 times to strip away all vestiges of live tissue, which could trigger rejection, then coated with cartilage cells grown from Castillo’s own adult stem cells to trick her body into accepting the transplant, the doctors said in The Lancet. She was released from the hospital 10 days after the June operation and isn’t taking drugs to suppress her immune system, a standard approach to prevent the body from rejecting transplanted organs.

“We think that this first experience represents a milestone in medicine and hope that it will unlock the door for a safe and recipient-tailored transplantation of the airway in adults and children,” said the physicians, led by Paolo Macchiarini, head of the thoracic surgery department of the Hospital Clinic in Barcelona.

Difficult To Treat
Damage to the large airways — the trachea that runs down the throat and the bronchial tubes that connect it to the lungs – – is difficult to treat. Previous grafts of more than six centimeters (2.4 inches) have failed, so the successful transplant of the seven-centimeter windpipe for Castillo’s left main bronchus suggests tissue-coated replacements may become an alternative for treating diseases of the upper airways.

Castillo hasn’t produced any antibodies against the donor windpipe and her lung function is in the normal range for a woman her age, doctors said. She is able to walk 500 meters (1,600 feet) without stopping, climb stairs and take care of her children, aged 4 and 15.

Macchiarini performed the operation in Barcelona and was the lead investigator on the grant used to conduct the preliminary work. The cleansing of the trachea, from a 51-year-old woman who died of a brain hemorrhage, was done using a technique created at the University of Padua in Italy.

Stem Cells
Castillo’s stem cells were extracted from her bone marrow then grown into cartilage cells at the University of Bristol in the U.K. The donated trachea was coated on the outside with the cartilage cells and lined on the inside with Castillo’s healthy epithelial cells to create a hybrid organ using an incubator developed at Politecnico di Milano in Italy.

“Just four days after transplantation the graft was almost indistinguishable from adjacent normal bronchi,” Macchiarini said in a statement. “After one month, a biopsy elicited local bleeding, indicating that the blood vessels had already grown back successfully.”

The initial results of the surgery are impressive, wrote Toshihiko Sato and Tatsuo Nakamura, from Kyoto University’s Institute for Frontier Medical Sciences, in a comment that accompanied the study. More information and follow-up is needed to fully evaluate the results, they said.

The bio-engineered approach of using donor scaffolds coated with tissue grown from the patient’s own stem cells may one day be used for other types of transplants, the investigators said.

“Surgeons can now start to see and understand the very real potential for adult stem cells and tissue engineering to radically improve their ability to treat patients with serious diseases,” said Martin Birchall, who oversaw the growing of the stem cells at the University of Bristol. “We believe this success has proved that we are on the verge of a new age in surgical care.”

To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net

Stem cell companies awaiting sea change

By David Morrill
Staff writer, Insidebayarea.com

A cure for diabetes? New organs? Spinal injury repair?

For more than a decade Bay Area scientists and companies have thrown out grandiose possibilities that might be possible via stem cell research.

But for the better part of that time, stem cell companies hopes have been hog-tied by a Bush administration that limits funding available to research. President Bush has been opposed to the science because he feels the destruction of human embryos is immoral.

President-elect Barack Obama has made it clear that one of his first executive orders will be to reverse this policy. Companies such as Alameda-based Biotime, Menlo Park-based Geron and South San Francisco-based VistaGen finally see this as a sign that their chance to operate freely might soon be near.

“It is a fact that President Bush’s policies have had a dampening effect on research over the past years,” said Michael West, chief executive of BioTime. “Many companies, both smaller biotech and larger Pharma companies, have been reluctant to invest in the technology due to the uncertain federal policy.”

Embryonic stem cells are early-stage cells capable of being grown into hundreds of cell types that are used in the human body. Stem cells created prior to 2001 are not restricted by research funding, but only about 21 of those lines are available, most created in ways that preclude use in humans.

“I think it’s going to be a significant positive because it will open up
additional grant funding for research,” said Ralph Snodgrass, CEO of South San Francisco-based VistaGen. “The last years have been difficult and frustrating on a number of different levels.”

The biggest change would likely be that the National Institutes of Health will be able to open up additional grant funding for research.

When scientists isolated the first stem cells from a human embryo in 1998, it was heralded as a breakthrough. A decade later, no company has sought approval for a therapy using embryonic stem cells, and the $150 million “stem cell market” consists entirely of equipment used to study the technology, according to research firm TriMark Publications. Most investors have instead focused on the $300 billion U.S. drug market that has been seen as less of a risk.

It also has allowed other countries that do embrace embryonic cell research, such as China, to catch up, said Michael Werner, president of Washington, D.C.-based the Werner Group, which consults life science companies.

“Not only will this have a direct implication on the federal funding, but hopefully now any kind of stigma or cloud over the embryonic stem cell industry will be lifted,” Werner said. “This science is so valuable, and now we will really be able to pursue all these avenues of research.”

West says he knows “concrete examples” of companies and academia not doing anything in stem cell research because of fear over uncertain federal policy.

As early as last week there’s been a shift in attitudes.

Pfizer Inc., the world’s largest drugmaker, is scheduled to open a new research center this month to research stem cells to treat nervous system disorders. The second largest drug maker, GlaxoSmithKline, has put money into stem cell development as well.

At the BioTime headquarters, there is state-of-the-art equipment ready to be utilized to study the technology once funding to do so is received.

Some analysts say the new challenge for these companies will now be to get private funding from venture capital firms.

Shareholders seem to have their eyes set on stem cell companies as well.

On Monday, shares of BioTime climbed 16 percent to $2.01. Since May 19, when shares were 46 cents, it has climbed 357 percent during one of the most challenging times on Wall Street.

West says both he and his colleagues hopes Obama will set ambitious goals for science, similar to President Kennedy’s target to land a man on the moon.

“A clear signal from President-elect Obama that he will make it a priority to put in place federal policies accelerating new medical technologies to alleviate human suffering and cut the medical costs associated with the baby-boom generation age wave, could have a dramatic effect on the industry,” he said.

The Associated Press contributed to this article. Staff writer David Morrill covers biotechnology. He can be reached at dmorrill@bayareanewsgroup.com.