ABC Barbara Walters special to highlight Advanced Cell Technology

The stem cell company Advanced Cell Technology Inc. will be featured on an ABC Television special report Tuesday night.

The company (OTCBB: ACTCNews), which maintains facilities in Alameda and Worcester, Mass., is to be featured on the Barbara Walters-hosted program: “Live to 150, Can you Do It? Secrets to Living Longer” set to air at 10 p.m.

Dr. Robert Lanza, Advanced Cell Technology’s chief scientific officer, will be interviewed on the program and talk about some of his company’s development programs, including efforts to create human embryonic stem cell lines without damaging the embryo itself.

Scientists believe they can use human embryonic stem cell lines to treat a variety of diseases.

Advanced Cell Technology moved its headquarters from Worcester to California in 2006 to take advantage of a $3 billion stem cell research initiative approved by that state’s legislature.

Boston Business Journal

In Election Year, Stem Cell Question Grows Still Gnarlier

03.03.2008
by Amber Fields

Bush says he won the war, but the prez ain’t seen nothin’ yet.


In his January 2008 State of the Union address, President George W. Bush claimed that research by James Thomson of the University of Wisconsin and Shinya Yamanaka of the University of Kyoto in Japan would finally end the morally and politically nettlesome debate over embryonic stem cell research. Thomson and Yamanaka had published independent studies the previous fall saying they could turn normal skin cells into inducible pluripotent stem cells (ones that are most therapeutically useful because they can become any of the 200 different types of cells in the body); Bush was saying that this new type of stem cell would give us all the biological usefulness of the embryonic variety with none of the nasty ethical hang-ups.

With all due respect to our would-be scientist-in-chief, research in this fast-moving field is likely to smudge, if not erase, the bright line he tried to draw. Take the recent finding announced in January by Advanced Cell Technology, a Massachusetts-based biotech company. ACT scientists modified a diagnostic procedure used in fertility clinics to create the first embryonic stem cell lines without destroying the embryos in the process. “The [stem cell] lines we generated are the real thing. We still don’t know if [the cells created by Thomson and Yamanaka] are going to do all the same things as normal embryo-derived stem cells,” says ACT Chief Scientific Officer Robert Lanza.

So as President Bush nears the end of his term, the future of human embryonic stem cell research is as uncertain than ever. There are ethical questions (is the ACT approach really acceptable to hard-core pro-lifers?), scientific questions (do the Thomson/Yamanaka and ACT approaches produce therapeutically useful cells?), and important political questions, in no small part because the presidential candidates are divided on their approach to stem cells.

Democrat Hillary Clinton vows to end Bush’s “assault on science” and has been the most vocal in her support of embryonic stem cell research. She would rescind Bush’s 2001 ban on funding of embryonic research that creates new cell lines and/or destroys embryos. Barack Obama also supports relaxing federal restrictions on research of these dynamic cells. Obama and Clinton both voted for the Stem Cell Research Enhancement Act, which would have broadly extended federal funding to human embryonic stem cell lines but was vetoed by Bush in 2006 and 2007.

As for the Republican candidates, John McCain has taken a more moderate position. McCain voted in favor of the Stem Cell Research Enhancement Act and in the first Republican presidential debate he reiterated his support for federal funding. But last April he also voted for the HOPE Act, a Bush-supported “compromise” bill that would open up federal funding for research that does not involve the creation, destruction, or injury of embryos; seeing as there are not yet any embryonic stem cells lines that meet this condition (ACT hasn’t yet proven that their technique poses no “risk of injury”), the HOPE funding would only be available for non-embryonic stem cells. Both Obama and Clinton voted against the Hope Act and many stem cell research supporters have criticized the bill, saying it’s a distraction and diversion of funds away from the greater promise of embryonic cells.

Republican candidate Mike Huckabee most closely reflects the stance of the current administration. His election would likely maintain the status quo, advancing the “ethically appealing” skin cell-based research of Thomas and Yamanaka while continuing to keep federal funds away from any new embryonic stem cell lines.

One big step for Geron

Using human embryonic stem cells, the Menlo Park company has developed a therapy that enables paralyzed rats to walk and that it claims shows no dangerous side effects in experiments with about 2,000 animals.

Others also are studying such cells for medical uses, including Stanford University scientists, who last week said they had used them to help stroke-disabled lab rats walk better. But none are as close to seeking permission for human tests as Geron, whose treatment is for spinal injuries.

For its application requesting regulatory approval from the U.S. Food and Drug Administration, the public company has gathered 25,000 pages of data – far more than normal for such requests, Geron Chief Executive Dr. Thomas Okarma said. He told analysts recently that Geron would submit it to the FDA during the first part of this year. But he declined to reveal the actual filing date, he said, “to minimize any kind of pressure on the agency.”

Yet Geron’s bid isn’t certain.

Although the FDA would not comment on Geron’s application, President Bush objects to most research with embryonic stem cells, which come from discarded embryos. Moreover, his administration has become intrigued with recent studies showing skin cells can be manipulated to have embryonic-like properties without harming an embryo.

In addition, although Geron says it has found nothing unsafe about its treatment, some scientists fear embryonic stem cells might cause tumors or other health problems.

Geron isn’t alone in its quest.

Los Angeles-based Advanced Cell Technology also expects to get FDA approval this year to test people with an eye treatment made from human embryonic stem cells.

Nonetheless, Okarma said he is confident he’ll be allowed to do the human study.

He and other scientists say the skin-cell technique has technical problems. And he claims no other firm can beat him to the punch.

“They’re not even close,” he said. “All these companies are Geron wannabes. . . . We are the pioneers of this and we will reap all of the fruits of that pioneering work.”

More than 250,000 people in this country have spinal injuries and about 11,000 new cases are reported in the United States each year, according to federal data. For now, most of those suffering paralysis have little hope of regaining their physical functions, said Marcie Roth, executive director of the National Spinal Cord Injury Association in Maryland.

“Our hats are off to companies like Geron,” Roth said.

Even if Geron gets to try its cells on people, it could take years for the treatment to be approved for widespread use, said Graig Suvannavejh, an analyst with UBS Investment Research, who doesn’t own Geron stock.

However, Ren Benjamin, a Rodman & Renshaw analyst who also owns no Geron stock, said getting the OK for the study could mean a quick payday for Geron, because “investors may get excited and buy shares of the company.”

That could be a big boost to Geron, which has consistently lost money since going into business in 1992. It has no products on the market for patients, although it has several in the works.

The company is developing drugs for various types of cancer and HIV. It’s also considering using human embryonic stem cells to help people suffering from heart attacks, osteoporosis and liver disease, among other ailments.

Yet Geron’s revolutionary spinal treatment, which it began researching in 1995 with investors’ funding, has generated the most media attention. That’s largely due to a breakthrough Geron reported in 2005 when a study it financed showed the treatment could help paralyzed rats walk.

Embryonic cells can turn into any type of tissue in the body, which is why many scientists think they may have a myriad of medical uses. For the rat study, the cells were coaxed into developing into oligodendrocytes. Those are cells that help nerve fibers replace myelin, a fatty substance that provides insulation, which is important for motor function.

When a spine is damaged, myelin often is stripped off. That can disrupt the body’s ability to transmit sensory signals – similar to the way an electrical cord shorts out when its insulation is peeled away – resulting in paralysis.

Okarma said the FDA required his company to go to extraordinary lengths to prove the treatment won’t harm people. Given the study’s unprecedented nature, that is appropriate, said Alan Trounson, president of the California Institute for Regenerative Medicine, which also finances human embryonic stem-cell research.

“Walking forward purposefully and carefully in this area is what we should be doing,” Trounson said.

Many human embryonic stem-cell colonies scientists have been studying are bathed in mouse skin cells, which provide nutrients but also can transmit viruses or other harmful substances to people. So Geron had to create a way to make such colonies without using mouse cells.

In addition, the FDA required Geron to prove that hundreds of rats injected with the cells could remain free of tumors and other toxic side effects for nine months to a year. The company successfully did that, Okarma said, but it was hugely labor intensive.

Under anesthesia, the rats were given injuries much more severe than a paralyzed person normally would experience. That left the animals incapable of regaining bodily functions – even with the treatment. So Geron’s researchers had to manually empty each rodents’ bladder three times a day for the entire period to keep the rats’ kidneys from failing.

Given the sensitivity of the topic and the amount of data Geron has gathered, it could take the FDA months to render a decision. That might enable Advanced Cell Technology, which had been well behind Geron in readying its treatment for human tests, to narrow the gap.

Advanced Cell, which has an office in Alameda, has used human embryonic stem cells to grow retinal pigmented epithelial cells, which it hopes to turn into a treatment for eye diseases such as retinitis pigmentosa and age-related macular degeneration.

It’s chief executive, William Caldwell, said he hopes to ask the FDA within months to begin testing the treatment in people. But he said if Okarma is the first to start a human study that’s OK, because “I’m one of his greatest fans.”

Not everyone is so charitable. Noting that Geron has been saying for several years that it hoped to soon ask the FDA for permission to do the study, some critics have accused the company of raising false hopes. But Okarma is undeterred.

“There will be a lot of surprised people, not only that we’ll do it but that the agency approved it,” he said. “We know we’ll be the first.”

Stem Cell Agency Might Offer Loans

A taxpayer-funded program capable of lending money to cash-starved California biotechnology companies has caught the attention of local stem cell industry executives who say they’re struggling to attract traditional investors and can’t qualify for federal money.

For the first time in its three-year history, the San Francisco-based California Institute for Regenerative Medicine is considering lending a portion of its $3 billion in available state funds to biotechnology companies. The so-called “biotech bank” would provide low interest loans to companies that qualify.

The stem cell agency’s governing board has approved 156 research grants totaling almost $260 million to universities, nonprofit agencies and individual scientists.

The agency, established in early 2005 after California voters passed Proposition 71 in November 2004, is the largest source of funding for human embryonic stem cell research in the world. The California Stem Cell Research and Cures Initiative allows the institute to grant or loan money for stem cell research and other biomedical research.

Local industry leaders, who met with members of the stem cell agency’s oversight committee in San Diego last week as part of a biotech loan task force, expressed interest in obtaining loans through the program, but questioned the qualifications and restrictions involved.

Local representatives from the California Healthcare Institute, International Stem Cell Corp., Invitrogen Corp. and Novocell Inc. joined a panel also comprised of representatives from Los Angeles-based Advanced Cell Technology Inc., Menlo Park-based Geron Corp. and StemCells Inc. of Palo Alto.

Local Interest

“As a for-profit company, I believe the program makes a lot of sense,” said William Adams, co-founder and chief financial officer of International Stem Cell Corp. in Oceanside. The company announced last year that it had developed cell lines capable of avoiding immune system rejection, a common dilemma facing stem cell researchers.

Joydeep Goswami, vice president of stem cells and regenerative medicine at Invitrogen, says the Carlsbad-based company is also interested in applying.

“As any large company or small company knows, we have more ideas that merit funding than we can fund internally,” he said.

Multimillionaire real estate investment banker Robert Klein, who serves as the institute’s unpaid chairman, has proposed the loan program as a means of filling the funding gap between scientific research and commercial development. Researchers refer to the gap as the “valley of death,” or the area where funding dries up, leaving some scientific ideas dead.

Klein has suggested offering between $500 million and $750 million in loans to companies that qualify for the program, which he estimated could “recycle” $1.5 billion back to the state agency.

Some say the program could offer support during a time when investors have shied away from funding embryonic stem cell companies because of the risk involved.

From Stem Cell To Immune System

Scientist Live
Date: 13/02/2008

A new study demonstrates for the first time that embryonic stem cells can be used to create functional immune system blood cells, a finding which is an important step in the utilisation of embryonic stem cells as an alternative source of cells for bone marrow transplantation. This hopeful news for patients with severe blood and immune disorders, who need these transplants for treatment, was prepublished on-line in Blood, the official journal of the American Society of Hematology.

Embryonic stem cells (ESCs) are being intensely investigated as a renewable source of primitive cells theoretically able to regenerate all tissues and organs. The use of ESC-derived blood-forming cells may have an important advantage over traditional transplants that use bone marrow, umbilical cord blood, and peripheral blood from donors. The antigens on the surface of donated cells must be compatible (determined by a method called HLA matching) with those of the patient to prevent rejection. The use of embryonic stem cells, which have low levels of these antigens and may therefore be less likely to provoke a defencive reaction by the patient’s body, may allow patients who can’t find suitable HLA-matched donors to receive transplants.

Previous studies have shown that mouse ESCs can be coaxed to form blood-forming hematopoietic cells by introducing a protein called HOXB4, known for its unique ability to greatly enhance cell proliferation, into them. These cells could then be transplanted into mice whose own marrow had been destroyed by radiation, rescuing their marrow function and beginning to produce necessary blood cells. However, previous studies have not investigated whether ESC-derived bone marrow in these mice could regenerate normal immune function – in particular, if they could allow the mice to respond to viruses or vaccines. Because foetuses have no need for a functional immune system as they are protected from the environment while in the womb, it was unclear if ESC-derived marrow would recreate an immune system at all or just very slowly.

In this study, a team of scientists from Iowa, Taiwan, and Germany used HOXB4-containing ESCs to engraft the bone marrow and rescue mice that genetically lacked any immune system and had been irradiated to destroy their bone marrow. Only cells containing HOXB4 were able to engraft, rescue the mice, and produce blood cells long term. These engrafted cells were shown to be derived from the transplanted ESC-derived cells.

To determine if these transplants were able to rebuild the defunct immune system, the scientists injected the mice with LCMV, a common rodent virus, and watched for T-cell activity, a sign that the body was defending itself against the infection. Although the number of T cells generated by the new haematopoietic cells was low, they were able to respond effectively to the virus. In addition, the transplanted haematopoietic cells were also able to produce B cells and other defencive cells called antigen-presenting cells, which have a role in signalling T cells to action. They also tested the ability of the mice to respond to vaccination and demonstrated the induction of specific immune cells. Although the level of immune response was not what is seen in normal adult mice after exposure to the virus or vaccine, it was measurable and effective.

The study was also encouraging in that none of the 70 transplanted mice followed for more than 200 days developed any tumours – another concern when using ESCs for tissue regeneration.

“These results show, for the first time, that functional white blood cells, the key players in the body’s immune system, can be successfully derived from embryonic stem cells expressing HOXB4,” said lead study author Nicholas Zavazava, MD, PhD, Professor of Internal Medicine and Director of Transplant Research at the University of Iowa Hospitals and Clinics in Iowa City and Staff Physician at the Iowa City VA Medical Center. “Therefore, we’re hopeful that these exciting findings are the first step toward new, improved therapies for patients.”

UCLA Researchers Confirm New Stem Cell Breakthrough

Los Angeles, Feb 14, 2008 / 03:28 am (CNA).- U.S. scientists have reprogrammed human skin cells into cells with characteristics similar to those of embryonic stem cells, confirming the breakthrough discovery made by a Japanese researcher, according to news reports.

Stem cells are considered to have significant potential for medical treatments including tissue regrowth and transplants. While some stem cells can be extracted from adult tissue, others are produced through the controversial process of cloning human embryos and destroying them to harvest their cells. Embryonic stem cells have the ability to become every cell type found in the human body.

Scientists at the University of California at Los Angeles genetically altered human skin cells using four regulator genes, publishing their findings in the February 11 edition of Proceedings of the National Academy of the Sciences.

Their process produced what are called induced pluripotent cells, or IPS cells, that are almost identical to human embryonic stem cells in function and biological structure.

The lead author of the study was Kathrin Plath, an assistant professor of biological chemistry and a researcher with the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research. She described the research in a prepared statement.

“Our reprogrammed human skin cells were virtually indistinguishable from human embryonic stem cells,” she said. “Our findings are an important step towards manipulating differentiated human cells to generate an unlimited supply of patient specific pluripotent stem cells. We are very excited about the potential implications.”

The UCLA research confirms the similar work of researchers Shinya Yamakana at Kyoto University and James Thomson at the University of Wisconsin. Plath said the studies demonstrate human IPS cells can be easily created by different laboratories and could mark a milestone in stem cell-based regenerative medicine.

The new technique could replace a stem cell harvesting method called somatic cell nuclear transfer (SCNT), sometimes called therapeutic cloning. At present, therapeutic cloning has not been successful in humans.

The first study author William Lowry, assistant professor of molecular, cell, and developmental biology, also addressed the findings in a statement.

“Reprogramming normal human cells into cells with identical properties to those in embryonic stem cells without SCNT may have important therapeutic ramifications and provide us with another valuable method to develop human stem cell lines,” he said.

Like other prominent stem cell researchers, Lowry claimed that embryonic stem cell research was still necessary.

“It is important to remember that our research does not eliminate the need for embryo-based human embryonic stem cell research, but rather provides another avenue of worthwhile investigation,” he said.

Stem Cell Donor Hears of Transplant Success

Published: 15 February, 2008

STEM cells donated by a Golspie man have enabled a crucially ill patient to live an almost normal life.

Michael Bonner of Rannoch, Tower Street, travelled to a London clinic in April last year where he underwent a procedure to harvest some of his stem cells.

He had been called by the Anthony Nolan Trust after it was discovered he was a suitable match for a patient, whose identity has not been revealed.Michael, a father of two, had previously registered with the trust following an appeal for donors by local mother Karen MacLeod. At the time she made the appeal Karen’s son, Mark Ballantyne, was suffering from a bone marrow disorder and in need of a transplant.

A number of local people responded and registered with Trust, but none was a suitable donor for Mark. He went on to receive bone marrow from an American donor but died in March last year. However, their names remained on the list and Michael, a building contractor and retained firefighter, was later contacted by the trust.

He initially flew to London where a battery of tests were carried out at the clinic to ensure he was fit enough to become a donor. He then returned home and was given a four-day course of injections to boost his blood cell production.

A second, two-day visit to the capital saw him undergo a relatively new technique called PBSC – peripheral blood stem collection. Less invasive than the traditional method, where the donor is operated on and has to be given a general anaesthetic, the PBSC technique involves inserting a needle into the donor’s vein and then drawing blood into a machine which extracts the stem cells. The blood is returned through the donor’s other arm.

Michael returned home and occasionally wondered how his stem cells had been used, but did not expect to hear any more about the matter.

But last week he unexpectedly received a letter from the Anthony Nolan Trust giving him a six-month progress report on the patient who had received his stem cells.

The trust’s donor welfare officer, Sharon Armbsy, wrote: “Following the successful engraftment of your cells, the transplant centre report that at this stage they consider their patient to be well.”

Ms Armbsy revealed that the patient was at home and his condition had been rated as 80 per cent on the Karnofsky scale – used to assess the level of activity of which the patient is capable. Eighty per cent is regarded as “normal activity with effort”.

But she warned Michael: “A difficult journey still lies ahead for your recipient and, in spite of this good news, significant changes may have taken place before we apply for the final report in April. Let us hope that I will be the bearer of good news again.”

Michael said he had been thrilled to receive an update on the patient’s progress and even more pleased to hear how well he was doing. He is keen to encourage other people to register with the trust and also to raise awareness of the new PBSC procedure.

Anyone interested in becoming a bone marrow donor can contact the Anthony Nolan Trust on 020 72841234 or e-mail newdonor@anthonynolan.org.uk. Visit http://www.anthonynolan.org.uk

Scientists: Stem Cells Colonies Created Without Harming Embryos

Thursday, January 10, 2008; 12:16 PM

Scientists in Massachusetts said today they had created several colonies of human embryonic stem cells without harming the embryos from which they were derived, the latest in a series of recent advances that could speed development of stem cell-based treatments for a variety of diseases.

In June, scientists in Japan and Wisconsin said they had made cells very similar to embryonic stem cells from adult skin cells, without involving embryos. But that technique so far requires the use of gene-altered viruses that contaminate the cells and limit their biomedical potential.

By contrast, the new work shows for the first time that healthy, normal embryonic stem cells can be cultivated directly from embryos without destroying them.
That means the work should be eligible for federal financing under President Bush’s six-year-old policy of funding only stem cell research that does not harm embryos, said study leader Robert Lanza, chief scientific officer at Advanced Cell Technology in Worcester.

But that is not likely, said Story Landis, who heads the National Institutes of Health stem cell task force, which oversees grants for studies on the medically promising cells.
The embryos Lanza used, which were donated for research, appear not to have been damaged, Landis acknowledged. However, she said, “it is impossible to know definitively” that the embryos were not in some subtle way harmed by the experiment.

And “no harm” is the basis of the Bush policy, she said.

Landis said the only way to prove that the technique does not harm embryos would be to transfer many of them to women’s wombs and see if the resulting babies were normal. But it would be unethical to do that experiment, she said, so the question cannot be answered.

That standard has Lanza fuming. By all scientifically recognized measures, he said, the embryos—currently frozen in suspended animation because they were donated for research and not to make babies—are normal, he said.

“I think the burden of proof lies with the NIH and the Bush administration to show that an embryo was harmed,” Lanza said.

The new technique involves the careful removal of a single cell from a newly formed eight-cell embryo and coaxing that cell to divide repeatedly until it forms a self-replenishing colony of embryonic stem cells.

Fertility doctors perform such “single-cell biopsies” thousands of times every year to test the genetic health of embryos conceived by in vitro fertilization, with little or no apparent effect on the remaining seven cells’ ability to form a normal baby. The idea is to check the removed cell for DNA defects and transfer to the woman’s womb only embryos whose cells test normal.

Lanza’s team first reported growing stem cells from individual embryo cells in 2006. But that work was criticized for not showing plainly that the plucked embryos could develop normally, relying instead on evidence from the nation’s many fertility clinics that embryos can survive the process.

In the new experiments, he and his colleagues allowed their seven-cell embryos to continue growing in laboratory dishes for up to five days—the oldest that embryos are typically cultured in fertility clinic labs before being transferred to a mother’s uterus.

Of 43 embryos biopsied, 36 (or 83 percent) developed into healthy five-day-old embryos, as determined by various measures used by the clinics, the team reports in today’s online edition of the journal Cell Stem Cell.

That’s a survival rate as good as or better than occurs with fertility clinic embryos generally, whether they are biopsied or not, according to several published reports.
“The biopsy had no effect on the embryos’ development,” Lanza said, adding that the effort produced five new colonies of stem cells. That is a much higher efficiency than was previously achieved. And because of improved culture conditions, the new stem cells do not need to be fed chemicals from destroyed embryos, as was previously the case.

“It is a technically impressive piece of work,” said Douglas A. Melton of the Harvard Stem Cell Institute. “They’ve demonstrated their ability to isolate human embryonic stem cell lines without destruction of the embryos”—something few scientists thought possible just a few years ago.

“But the fundamental ethical issue remains,” said Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University—namely, how to prove that the approach is inherently harmless.

Very few studies have looked at the outcomes of fertility treatments in which biopsies had been performed, Hudson said. And those that have been done—including a widely publicized July report that found that fertility clinic clients who had their embryos biopsied had about a 30 percent lower chance of giving birth—are riddled with flaws, she said.

But one thing is clear, Hudson said: “Embryo biopsy is tricky and requires extraordinary good hands and technical skills. And even in the best hands, embryos are sometimes lost.”

As long as that risk is there, funding under Bush’s policy will not be available, Landis said—with one possible exception.

Although NIH will not fund Lanza’s method of making stem cells, she said, the agency might fund studies on the cells themselves once they are isolated from the embryos with private money and the embryos are shown to be healthy.

Asked who would make that funding decision, Landis said it would be up to NIH officials. But pressed to say whether the White House would have an influence, she paused.

“I’m sure they would have an interest in such a decision,” she said.

Note: This article in its original format can be viewed here.

Stem Cell Breakthrough Leaves Embryos Unharmed

For the first time, human embryonic stem cells have been obtained without having to destroy the embryos they came from.

The breakthrough sidesteps the primary ethical objection to human embryonic stem cell (hESC) research – that embryos must perish to yield up hESCs.

The new technique generates stem cells by extracting and culturing a single embryonic cell, leaving the remaining embryo to develop normally.

The US researchers involved demonstrated that the procedure worked a year ago, but without proving that embryos could survive the process. Now, they have shown unequivocally that the embryos survive and could develop to full term.

“These are the first hESCs created without destroying embryos,” says Robert Lanza, chief scientific officer at Advanced Cell Technology, the company that pioneered the breakthrough in Worcester, Massachusetts.

Ethical approval

The hope now is that President George W Bush will now lift heavy restrictions on federally funded hESC research that he imposed in 2001 because of his own objections to embryo research.

“It’s here and now, and could increase massively the number of stem cells available,” says Lanza, who wants Bush to give immediate ethical approval for new cell lines to be produced using the ACT approach. “We could triple the number of hESC lines available within a few months,” says Lanza.

Since Bush’s clampdown in 2001, only 22 cell lines have been available for use by US government-funded researchers, but most are of such poor quality they are useless, so fresh supplies are desperately needed.

“Hopefully the president will do the right thing,” says Lanza. “We’ve been in dialogue with the White House, and it’s our understanding that they would wait until a peer-reviewed paper appeared before approving our approach.”
That paper has now appeared, in the journal Cell Stem Cell (DOI: 10.1016/j.xtem.2007.12013). In it, Lanza and his colleagues describe how they produced four new lines of hESCs from blastomeres – single undifferentiated cells that make up very early embryos.

Efficient process

By nourishing each blastomere with special blends of nutrients or growth factors, ACT produced new colonies of embryonic stem cells and demonstrated that these could be converted into all tissues of the body.

By introducing a new nutrient, a protein called laminin found in the base layer of
skin tissue, they massively improved the efficiency with which they converted blastomeres stably into hESCs.

Importantly, a fifth line has been produced using ACT’s method by Olga Genbacev’s team at the University of California at San Francisco, proving the procedure is replicable.

Despite praising the breakthrough, some researchers claim that it panders to people whose objections to current methods of extracting hESCs are morally groundless.

“It’s designed to appease people who oppose embryo research despite the fact that thousands of IVF embryos are discarded each year,” says Stephen Minger, director of the Stem Cell Biology Laboratory at King’s College London, UK.

Limited lines

Lanza accepts this to an extent, but says the objections have to be overcome to
kick-start US stem cell research. “The clock is ticking, and it keeps getting held up and held up,” he says.

Evan Snyder of the Burnham Institute for Medical Research in La Jolla, California, applauds the breakthrough, but says that moral opponents might still not be satisfied.

“Can one prove that the biopsied embryos, if implanted, would yield normal individuals?” he asks. “Opponents might claim even sillier arguments: that the embryos are donating cells without ‘informed consent’,” Snyder adds.

The other shortcoming of the technique is that it cannot provide stem cells matched to each individual patient, whereas two other technologies have the potential to do using the patient’s own skin or other cells – although each has its own limitations.

Lanza accepts that ACT’s procedure cannot be tailored to each patient, but estimates that around 100 different lines grown in stem cell banks would be enough to tissue-match and treat most individuals.

Journal reference: Cell Stem Cell (DOI: 10.1016/j.xtem.2007.12013)

Note: This article can be viewed in its original format here.

Companies Claim Stem-Cell Advance That Won't Harm Embryos

Article Launched: 01/10/2008 09:04:54 AM PST

Scientists at two California companies – including one in San Carlos – say they have created human embryonic stem-cell colonies without destroying an embryo by improving on a technique the White House and other skeptics scoffed at when it was first revealed in 2006.

“This new approach addresses the President’s ethical concerns,” said William Caldwell, chief executive of the Los Angeles-based company involved in the study, Advanced Cell Technology, which has an office in Alameda.

Susan Fisher, a stem-cell researcher at the University of California-San Francisco, who provided advice for the study, published today in the journal Cell Stem Cells, also praised the technique.

“For people for whom embryonic destruction is an obstacle in this kind of work, this is certainly an advance,” she said.

But Story Landis, who heads the federal government’s National Institutes of Health stem-cell task force, was non-committal. While calling the new procedure “extremely interesting,” she added, “we need to know more” about the method to make sure that embryos are not harmed in the process.

Richard Doerflinger, a bioethicist at the U.S. Conference of Catholic Bishops, was highly critical.

“It seems they’ve made some progress in reducing the direct destructiveness of the procedure,” he said. However, he added, “this is a rather shaky claim about making this procedure safe,” because while most of the embryos used to create the stem-colonies survived, a few did not.

Moreover, he said, creating stem-cell colonies from skin – as some scientists have shown to be possible recently – is far preferable because “it totally does not have any problem in terms of harming or destroying embryos.”

The new study involves a technique developed by Advanced Cell Technology and replicated by researchers at StemLifeLine in San Carlos.

When Advanced Cell Technology first published a study detailing the technique in 2006, it said it removed a single cell from a tiny, early-stage embryo and demonstrated that the cell could be turned into a stem-cell colony without destroying the embryo. That was hailed at the time by some stem-cell advocates as a major breakthrough.

Because human embryonic stem cells can develop into any type of tissue, many scientists believe it may be possible one day to create colonies of them that can be used for everything from growing replacement organs to creating treatments for diabetes and other diseases.

However, soon after Advanced Cell Technology’s first study was published, the company acknowledged it actually had not kept alive some of the embryos used to create the colonies. Its executives explained that their purpose was merely to demonstrate the technique would work, not to keep the embryos alive.

Nonetheless, the revelation in 2006 was denounced by Doerflinger. White House officials also said the procedure continued to raise ethical concerns about deriving stem-cell colonies from embryos.

In the latest study, Advanced Cell Technology executives said they found a better way to grow the cells removed from the embryos and that 80 percent of the embryos developed normally, although all of them eventually were frozen.

Contact Steve Johnson at sjohnson@mercurynews.com or (408) 920-5043.

Note: This article can be viewed in its original format here


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