IN THE NEWS - Updated Weekly!

Oct. 10, 2008 - Former President Clinton to stump for stem cells in Michigan

Oct. 9, 2008 - Edinburgh scientists' stem-cell research breakthrough brings diabetes cure nearer

Sept. 26, 2008 - CureMichigan Launches Stem Cell Research Ad

Sept. 3, 2008 - McCain is pro life???

Aug 26, 2008 - Stem cell research, medical pot on ballot

July 3, 2008 - Stem Cell Research From an Ethical Point of View

June 20, 2008 - O’Malley: $1.1B Biotech Plan Will Pay Off

June 14, 2008 - Guidelines for Translating Stem Cell Therapies from the Lab to the Bedside

June 9, 2008 - Public Funding Impacts Progress Of Human Embryonic Stem Cell Research

May 28, 2008 - Where they stand: Stem cell research

May 12, 2008 - California Stem Cell Research Program Approves Statewide Laboratory Construction Program

May 7, 2008 - 1.1 Million Euro Stem Cell Project Combines Expertise of DASGIP With The Fraunhofer Institute For Cell Therapy And Immunology

Apr. 15, 2008 - Sperm and eggs from stem cells ‘in 15 years’

Apr. 7, 2008 - Clinton On The Issues

Mar. 31, 2008 - Indian American's film on stem cell research for Cannes

Mar. 24, 2008 - Experts urge stem cell research reality check

Mar. 17, 2008 - VistaGen Therapeutics Announces Broad Stem Cell R&D Alliance

Mar. 9, 2008 - Brazil court puts off stem cell ruling

Mar. 2, 2008 - Cash boost for stem cell research

Feb. 25, 2008 - Stem cell compromise advances

Feb. 13, 2008 - Stem cell scientists explore options

Jan. 28, 2008 - Stem cell research company clones human embryo

Jan. 21, 2008 - Cloning Said to Yield Human Embryos

**For More Past Articles Click Here!

Former President Clinton to stump for stem cells in Michigan

Former President Bill Clinton is set to stop in Michigan to campaign for a state proposal that would loosen restrictions on embryonic stem cell research.

Clinton has accepted the invitation of retail mogul and philanthropist A. Alfred Taubman to raise money today for CureMichigan. That's the group supporting Proposal 2 on the November ballot.

Clinton is scheduled to appear at the Taubman Air Terminal next to Oakland County International Airport. Tickets must be bought for members of the public who want to attend. Tickets are $2,500, $1,000 and $500.

Taubman is scheduled to speak, along with Gov. Jennifer Granholm and former U.S. Rep. Joe Schwarz.

The proposal would change state law to allow people to donate embryos left over from fertility treatments.

Edinburgh scientists' stem-cell research breakthrough brings diabetes cure nearer

By BRIAN HORNE
SCIENTISTS at Edinburgh University yesterday revealed they have moved a step closer to a cure for diabetes, thanks to groundbreaking stem-cell research.

The team has overcome a major hurdle in creating pancreas and liver cells in the laboratory. Current techniques lead to a mixture of cells being created by stem cells taken from embryos – and if implanted they can lead to tumours forming. But the Edinburgh team has found a way of purifying the cells.

This means only liver and pancreas cells – known as endodermal cells – are produced. The cells constantly renew themselves in the lab, removing the need to harvest cells constantly from new embryos. The team claims the cells could be injected into diabetics, potentially curing them of their dependence on insulin injections.

Dr Josh Brickman, of the university's Institute for Stem Cell Research and Centre for Regenerative Medicine, said: "What we have done that is significant is, instead of just taking cells from embryonic stem cells and pushing them towards becoming liver and pancreas, we took them and pushed them towards the first step in becoming liver and pancreas cells. We then purified those cells away from the rest and developed them. This is the first time this has been done."

He added that the process would have to undergo rigorous testing before it could be considered for use in humans.

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CureMichigan Launches Stem Cell Research Ad

LANSING, Mich. -- An ad in favor the ballot proposal to loosen restrictions on embryonic stem cell research is to premiere Friday.

The CureMichigan commercial claims that statements made in an ad from an opposition group called Michigan Citizens Against Unrestricted Science and Experimentation are untrue.

It had said that the proposal would be costly to Michigan taxpayers, however, the proposal does not raise taxes.

Although the two groups have been accusing each other of misleading the public, it is the voters who will decide on Proposal 2 in November.

McCain Is Pro-Life???

Seems McCain supported funding for stem cell research even before new technology was created. See this from 2005:

http://firstread.msnbc.msn.com/archive/2008/03/25/806066.aspx

And, according to Mitt Romney, McCain flip flops a lot, even on abortion:

Senator McCain voted against the Bush tax cuts. Now he's for them. He was opposed to ethanol. Now he's for it. He said he was opposed to overturning Roe v. Wade. Now he's for overturning Roe v. Wade," Romney said, adding: "That suggests that he has learned from experience." - Mitt Romney

Apparently McCain actually stated once that he was against overturning Roe v. Wade, but then backpedaled. That makes Romney or McCain a liar. Which on is it?

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Stem cell research, medical pot on ballot

Backers of government reform to ask courts to put issue up for vote.

LANSING -- Michigan voters will decide at least two statewide ballot proposals Nov. 4: one allowing stem cell research, the other permitting seriously ill people to use marijuana legally.

But the battle continues to rage over a wide-ranging overhaul of the state constitution that, among many things, would reduce the size of the Legislature, Supreme Court and Court of Appeals, and reduce the salaries paid to lawmakers and judges.

The so-called Reform Michigan Government Now plan was kicked off the ballot by the Court of Appeals Wednesday for being too broad. Supporters said they'll appeal, as early as today, to the Michigan Supreme Court, and if they fail there, they will head into the federal courts.

"We're going to pursue every available avenue to get this before the voters," said Reform Michigan Government Now attorney Andrew Nickelhoff.

The proposal to relax state law on embryonic stem cell research was approved for the ballot Thursday by the Board of State Canvassers, which determined that backers had turned in nearly a half-million valid signatures -- more than 100,000 beyond the required minimum. The board on Thursday approved the ballot wording of brief summaries for the stem cell proposal and the marijuana plan, whose signatures already had been deemed sufficient.

Proponents and opponents of the stem cell question are expected to spend a combined $20 million or more on their campaigns.

Joe Schwarz, a Battle Creek physician who heads the group backing the stem cell proposition, predicted voters will approve it.

"This is a step forward," said Schwarz, who served in both the Michigan Legislature and Congress. "Nearly all of the therapy that evolves in the 21st century is going to be genetic therapy and cellular therapy.

"This research is going on in other states and should be going on here. We have some of the finest research facilities in the world at the University of Michigan, Michigan State University, Wayne State and others."

Critics oppose the measure on religious and moral grounds.

David Doyle, representing opponents, said it would undo a 1978 law banning the destruction of human embryos and leave in question a 1998 law prohibiting human cloning.

"It goes too far, has too many loopholes and would allow unlimited experimentation on human embryos," Doyle said.

Passage of the marijuana proposal wouldn't grant users immunity from prosecution, since marijuana use remains illegal under federal law. But as a practical matter, federal authorities haven't looked to prosecute those who use it for medical purposes in the dozen states where it's legal.

An estimated 50,000 Michigan adults with a "debilitating medical condition" may qualify for medical marijuana use. Patients would need doctor's approval, and carry a state ID card identifying them as legal pot users.

Advocates say it can alleviate symptoms of HIV/AIDS, cancer, hepatitis C and Alzheimer's.

Medically approved patients could legally possess 2.5 ounces of marijuana, although the ballot proposal is silent about where they could obtain it.

You can reach Gary Heinlein at (517) 371-3660 or gheinlein@detnews.com.

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Stem cell research from an ethical point of view

Stem cell research and the potential use of human embryonic stem cells in clinical therapy is a controversial issue which splits both scientific and public opinion. The current conflict over embryonic stem cells throughout the world deals particularly with the ethical implications of this promising, but delicate subject and the scientific manipulation of human life in its early stages of development. It is a symbolic struggle over the whole future of developmental biology – over how we will proceed with a wide range of research on human development. Alternative methods for gaining embryonic stem cells such as the Altered Nuclear Transfer (ANT) method developed by William B. Hurlbut, M.D., a member of The President's Council on Bioethics in Washington, D.C., are considered important steps torward embryonic stem cell research.

It is in this context that the new Springer book Stem Cells, Human Embryos and Ethics: Interdisciplinary Perspectives provides insight into this recent debate from several relevant fields. A medical and biological angle dealing with new technological possibilties in medical research and putative clinical therapy is presented as well as an ethical point of view including philosophical and theological approaches regarding the moral status of human embryos.

The various chapters of the book focus on one main problem: Is it acceptable from an ethical point of view to use stem cells from human embryos for scientific research and clinical therapy? And what are the weaknesses and strengths of various opinions and positions when they are critically evaluated? Moreover the book discusses several sub-problems strongly related to this topic, i. e. when does any individual human being begin or at what stage development does a human organism become entitled to the moral and legal protection which we give to the life of human adults?

Based on a two-year research project led by editor Lars Østnor, professor of systematic theology at MF Norwegian School of Theology in Oslo, the book is a comprehensive collection of papers covering all major aspects of the ethical debate presented in an unbiased way. Instead of presenting just on opinion like many monographic books on stem cell research ethics do, the various chapters all together give a multifaceted and balanced treatment of the subject allowing readers to examine the opinions of both religious and scientific scholars side by side. The seventeen chapters of the book Stem Cells, Human Embryos and Ethics: Interdisciplinary Perspectives include updated contributions from international respected scholars such as William B. Hurlbut and Sir Anthony Kenny.

I am of the strong opinion that the debate going on in many countries concerning stem cell research, and especially the use of human, embryonic stem cells, will profit substantially from a sufficient overview of the different aspects relevant for an ethical evaluation," said Østnor as a reason for editing this book.

Source: Springer

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O’Malley: $1.1B Biotech Plan Will Pay Off

BALTIMORE — Calling it a ‘‘sound investment,” state officials, researchers and stem cell advocates on Monday praised a plan for Maryland to invest $1.1 billion in the biotechnology industry over the next decade.

The Bio 2020 Initiative, announced by Gov. Martin O’Malley at the Johns Hopkins Institute for Cell Engineering, would create the Maryland Biotechnology Center, expand the state’s biotech investment tax credit and its technology incubator program, continue funding for stem-cell research, and increase investments in nanotechnology and the state’s venture program.

The plan will build on Maryland’s position as the home of government regulatory agencies, higher education and research centers and nearly 400 private biotechnology companies, O’Malley said.

‘‘We seek to take a giant step forward in harnessing all the potential that is already within our grasp,” O’Malley said.

‘‘Bioscience is, in many ways, the key to unlocking our future economic potential as a state,” he said. ‘‘... We are uniquely positioned among states for even greater leadership, not just within the continental United States, but within the whole world.”

The initiative, much of which will be left to the General Assembly to approve in future state budgets, would represent the largest per capita investment in the biosciences by any state, according to the governor’s office.

‘‘We know this is a sound investment,” said Del. Samuel I. ‘‘Sandy” Rosenberg (D-Dist. 41) of Baltimore. ‘‘We’re aware of the state’s strength in the life sciences.”

The program is based on early recommendations from the state’s new Life Sciences Advisory Board, which in the fall began work on a statewide strategic plan for biosciences. The board plans to issue a report this year.

H. Thomas Watkins, president and CEO of Human Genome Sciences of Rockville and chairman of the Life Sciences Advisory Board, issued a statement saying O’Malley has a ‘‘bold vision” for life sciences in Maryland.

The investment has immediate benefits for patients, said John Kellerman, president of Maryland Families for Stem Cell Research.

‘‘This funding goes a long way in retaining our current researchers, attracting future investigators, and most importantly, providing hope for possible therapies and potential cures for thousands of Marylanders living with deadly diseases and injuries,” Kellerman said.

The announcement comes on the heels of O’Malley’s trip to Israel last month, where he met with Israeli leaders and bioscience executives.

More than 30 Israeli-owned companies do life science research in Maryland, O’Malley said.

Later this week, O’Malley will fly to San Diego to attend BIO 2008, the world’s largest life sciences conference.

‘‘We have had a lot of people bragging about our biotech, but other [states’ governments] have put more of an effort into helping their industry along,” said John Holaday, former CEO of Rockville biotech EntreMed and now managing director and CEO of QRxPharma, who was attending BIO 2008 this week. ‘‘This will put us on par with what other states are doing. Hopefully the amount of money that is spent will be used to help later-stage companies, as well as startups. That’s what we need more of in Maryland.”

The initiative includes:

*A ‘‘one-stop shop” Maryland Biotechnology Center to showcase and support biotechnology innovation and entrepreneurship in Maryland, and consolidate state, academic and private-sector ventures. It would include the Maryland Technology Development Corp.’s tech-transfer initiatives, the state labor department’s regulatory functions and University of Maryland programs.

*Doubling the $6 million biotech investment tax credit in fiscal 2010 and again in 2013, which could leverage almost $50 in private investment.

*Adding $60 million to the state’s Technology Incubator Network over the next decade, leveraging $120 million in private and federal investments and growing the program by 50 percent.

*Growing Maryland’s Venture Fund, which provides challenge grants to startups and makes equity investments in more established companies, by investing $152 million by 2019, leveraging almost $2 billion in private equity.

*Spending at least $20 million a year on stem-cell research. The General Assembly approved $19 million for such research in fiscal 2009, which begins July 1.

Life science companies want to be in Maryland, said David W. Edgerley, secretary of business and economic development.

The O’Malley administration must convince the General Assembly that the initiative is worth the money, he said.

Business incubators create new jobs, buildings and tax bases for the state, he said. Tax credits spur economic activity.

‘‘It’s going to have to stand on its own merits in the legislative process,” Edgerley said of the plan. ‘‘We’re going to have to do a good job of making sure that we convince everyone that there is an adequate return in that investment. It really can pay for itself.”

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Guidelines for Translating Stem Cell Therapies from the Lab to the Bedside

At the sixth annual meeting of the International Society for Stem Cell Research, a task force of leaders in the field announced a draft set of guidelines to ensure that rigorous best practices are applied to the clinical translation of stem cell research from the laboratory to human subjects.

Newswise — The Internet is rife with provider Web sites and patient testimonials touting exciting new stem cell treatments for paralysis, Parkinson’s disease, heart failure and cancer. And every year, desperately ill patients travel thousands of miles to seek experimental stem cell therapies with bold claims of cures for such intractable diseases.

Few, if any, of these putative treatments are based on sound pre-clinical data that have been published in peer-reviewed journals. Today, there are no proven treatments based on stem cells other than those for blood disorders, like leukemia and immune deficiencies. All other stem cell treatments are still highly experimental.

At the sixth annual meeting of the International Society for Stem Cell Research, a task force of leaders in the field announced a draft set of guidelines to ensure that rigorous best practices are applied to the clinical translation of stem cell research from the laboratory to human subjects. The guidelines are the culmination of months of discussion by scientists, ethicists, public policymakers, clinicians, industry representatives and members of the public from 13 countries. (The full guidelines will be posted at www.isscr.org.)

“These guidelines are critically important to the future success of the field,” according to Dr. George Q. Daley, ISSCR president and associate director of the Stem Cell Program at Children’s Hospital Boston. “Not only does the use of untested therapies put patients at risk, it jeopardizes the legitimate practice of all translational stem cell research.”

In strongly worded language, the guidelines “condemn” the use of stem cell therapies outside of an established clinical trial, particularly when patients are charged for “advertised medical services that constitute experimental, unproven and unestablished interventions.” The guidelines call upon regulators in countries where these putative therapies are offered to regulate such practices to prevent exploitation of vulnerable patients. The guidelines call upon scientists and clinicians to conduct research with transparency and adherence to rigorous independent scientific and ethical review.

The guidelines address three major areas of the clinical translational process involving all types of human stem cells and their direct derivatives, including cell processing and manufacturing; pre-clinical studies; and clinical research. The guidelines also make specific recommendations for ethical oversight, peer review of studies, informed consent and protection of subjects, avoidance of conflict of interest, clinical trial design and reporting, and long-term follow up of patients. Also addressed are issues of social justice, such as public engagement in policy making and fair access to treatment, in particular, offering affordable treatments to patients in resource-poor countries.

The guidelines do allow for treating a specific patient or small numbers of patients outside of a clinical trial in “exceptional circumstances of justified medical need” where reasonable scientific evidence exists that the patient or patients might benefit and not be harmed. All clinical trial regulations related to informed consent, clinical follow-up, independent expert review and institutional support and accountability still apply.

Following a solicitation of comment period from June 12 to Sept. 15, 2008, the task force will develop a final version of the guidelines, expected to be released by the end of the year. At that time, the ISSCR will release an advisory for patients considering stem cell therapy to help guide them in evaluating programs and treatments. The advisory will be posted on the ISSCR Web site, www.isscr.org.

The guideline’s task force was chaired by Dr. Olle Lindvall and co-chaired by Dr. Insoo Hyun. Four working groups participated in their development: the Quality Control and Manufacturing Subcommittee, chaired by Dr. Mahendra Rao; the Preclinical Testing Subcommittee, chaired by Dr. Giulio Cossu; the Clinical Trials Subcommittee, chaired by Dr. Ira J. Fox; and the Social Justice Subcommittee, chaired by Dr. Laurie S. Zoloth.

The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.

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Public Funding Impacts Progress Of Human Embryonic Stem Cell Research

ScienceDaily (Jun. 5, 2008) — Bolstered by supportive policies and public research dollars, the United Kingdom, Israel, China, Singapore and Australia are producing unusually large shares of human embryonic stem cell research, according to a report from the Georgia Institute of Technology in the June 2008 issue Cell Stem Cell.

Aaron Levine, assistant professor of public policy and author of the book Cloning: A Beginner's Guide, studied how countries output of research papers related to human embryonic stem cell research compared to their output in less contentious fields. He found that even though the United States still puts out far more research in this field than any other single country, when one compares the amount of research in human embryonic stem cells to other forms of research in molecular biology and genetics, the U.S. lags behind.

"The U.S. is still the largest producer of research in this field, but compared to other similar fields, our share is smaller," said Levine, assistant professor in Georgia Tech's Ivan Allen College of Liberal Arts. "You have to ask yourself, are we happy producing this relatively small share?"

In comparison, the study showed that the U.K. and Israel were producing substantially more research in this area than in other fields. According to the study, the U.K. produced 5.3 percent more research related to human embryonic stem cells than research performed in other areas of molecular biology and genetics, while Israel produced 4.6 percent more research. Levine attributed that to the long-held public and political support of human embryonic stem cell research in those countries.

"Both the U.K. and Israel have long-standing policies that support research in this field," said Levine, "And this support seems likely to have bolstered scientists' efforts to set up labs and acquire funding for their research."

But the biggest surprise was China and Singapore, with China producing 3.2 percent more human embryonic stem cell research than other areas of molecular biology and genetics, and Singapore producing 2.6 percent more research.

"China and Singapore both showed impressive performance in human embryonic stem cell research," said Levine. "Although these countries are very different, both have been striving to grow their biomedical research communities and it seems likely they focused on human embryonic stem cell research, in part, because they saw that traditional scientific powerhouses like the United States were moving so tentatively in this area."

Australia had a more mixed policy and a more mixed result. While Australia does allow new stem cell lines to be created from fertility treatments, it explicitly banned the use of stem cells derived from somatic cell nuclear transfer from 2002 to 2006. Beginning in 2006 scientists were allowed to use stem cells from somatic cell nuclear transfer, but under strict regulatory guidelines. That may explain why Levine's study found that Australia showed a more modest result of producing only 1.6 percent more human embryonic stem cell research than other areas of molecular biology and genetics.

The United States, however, is significantly under-performing in this area. Although Levine's study found that the U.S. produced 36 percent of the research performed on human embryonic stem cells, far more than any other country, when he compared those studies to other areas of research in molecular biology and genetics, he found that the U.S. had a deficit of 10 percent.

Although the U.S. government is the funding source for 63 percent of academic research and development, federal funds can only be used for studies on a small number of stem cell lines produced before August 9, 2001. As a result, much research in this area in the U.S. is done either with state money or private money.

Given that scientists have less incentive in the private sector to publish research papers, it's possible that Levine's metric undercounts the amount of research done in this area in the U.S. But even so, the contribution from the U.S. is still reduced since research that isn't published does little to increase public knowledge.

But that may change. Venturing where the federal government fears to tread, states like California, New York, Connecticut and Maryland are becoming places researchers can turn to for human embryonic stem cell funding. But Levine thinks that development may complicate matters.

"There are a variety of funding sources out there now, but it makes the field more complicated for scientists to follow the various rules set forth by the states and foundations," said Levine. "I think scientists would prefer clear oversight from a federal government that's supportive of their research."

Levine plans to follow up this current work with a look at how collaboration is affected by these different state policies.

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Where they stand: Stem cell research

The Record asked the three Republicans and the three Democrats in the U.S. Senate primary June 3 about issues the Senate has confronted or is likely to confront in the coming term.

Their responses will appear each day. In some cases, answers are paraphrased or excerpted, but full audio recordings will be online on the Capital Games blog at northjersey.com/herbjackson.

Today's question: Would you vote for or against federal funding for embryonic stem cell research?

Robert Andrews, member of Congress, Haddon Heights, 50, Democrat:

"For it. I think it's long overdue and badly needed."

Donald Cresitello, mayor of Morristown, 61, Democrat:

"Yes" [for it].

Frank R. Lautenberg, U.S. senator, Cliffside Park, 84, Democrat:

"I am totally for embryonic stem cell research. It represents kind of a last- ditch hope ... and I think it's irresponsible of President Bush to limit this potentially lifesaving research."

Joseph Pennacchio, state senator, Montville, 52, Republican:

"That issue's totally changed. Those embryonic stem cells ... now can be gotten from human skin so that issue, quite frankly, in the near future's going to be a moot point."

Murray Sabrin, college professor, Fort Lee, 61, Republican:

"I would vote against [it], because as Thomas Jefferson said, to paraphrase him, people should not be forced to pay for policies or programs that they have a conscientious objection to."

Richard Zimmer, lawyer/lobbyist, Delaware Township, 63, Republican:

"I would vote for it. I believe ... there's significant potential for important breakthroughs in the science related to that area of research."

Saturday: Arctic oil drilling

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California Stem Cell Research Program Approves Statewide Laboratory Construction Program

The California Institute for Regenerative Medicine's Independent Citizens' Oversight Committee on Wednesday approved $271 million in grants to build 12 stem cell laboratories at academic and not-for-profit research institutions in the state, the New York Times reports. The grants represent the largest amount of money awarded at one time by the program. The approval has sparked debate as to whether it is unnecessary because of possible changes to the ban on federal funding on research that uses embryonic stem cell lines created after August 2001. According to the Times, all three main presidential candidates have expressed support for expanded funding for the research.

According to the Times, one reason CIRM distributed the grants for construction is because research on embryonic stem cell lines created after August 2001 "cannot share even a microscope with a project that is federally financed." However, Jesse Reynolds -- a policy analyst at the Center for Genetics and Society, which supports stem cell research but has criticized CIRM -- said that now that "the money is flowing" in California, those federal restrictions are going to be removed." Robert Klein, chair of CIRM, argued that the state could not take for granted that the federal restrictions would be lifted by the next president. He added that Republican presidential candidate Sen. John McCain (Ariz.) has expressed opposition to some types of stem cell research. Klein said that even if the restrictions are lifted, new laboratory space will be needed to expand research and to recruit scientists.

Some CIRM officials also said the construction would provide an economic stimulus during a time of a large state budget deficit and a weak economy (Pollack, New York Times, 5/8). California voters in 2004 approved a plan to invest $3 billion of tax funds over 10 years into embryonic stem cell research, and CIRM has already approved 156 research grants totaling $260 million (Daily Women's Health Policy Report, 2/13). The new grant recipients include nine of the 10 University of California campuses, Stanford University and the San Diego Consortium for Regenerative Medicine.

California Gov. Arnold Schwarzenegger (R) in a statement released after the board's decision said, "[T]his kind of public-private investment in a growing jobs section is exactly the kind of good news our economy needs right now." He added, "This will go a long way toward medical research that could save lives and improve them for people with chronic diseases" (Mohajer, AP/Examiner.com, 5/7). Wesley Smith -- a fellow of the Discovery Institute in Seattle and critic of CIRM -- said the spending is irresponsible. "Whether one supports or opposes the CIRM, the voters were told that their borrowed money would be used to pay for research into cures, not the construction of high-end luxury buildings," Smith said, adding, "And this at a time when [California] is drowning in $20 billion of red ink" (Russell, San Francisco Chronicle, 5/8).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

2008 The Advisory Board Company. All rights reserved.

1.1 Million Euro Stem Cell Project Combines Expertise of DASGIP With The Fraunhofer Institute For Cell Therapy And Immunology

DASGIP AG, a manufacturer of parallel cultivation systems for cell culture and microbiology, located in Juelich, Germany, and the Fraunhofer Institute for Cell Therapy and Immunology (IZI)located in Leipzig, Germany announce a cooperative effort in stem cell research. This 1.1 Million € project is aimed at the development of alternative drug testing methods without animal testing. The work is subsidized by the German Federal Ministry of Education and Research.

Taking prescription drugs during pregnancy can be harmful to the unborn child. Therefore, identifying the embryotoxic potential of a new drug candidate is an essential part of any preclinical study. These studies are currently conducted in animals according to OECD guidelines. In Europe, 11 Million animals are tested annually. About 50 percent of these tests are performed to explore the bone harming and thus the embryotoxic potential of such drug candidates.

Dr. Nicole zur Nieden, leader of the stem cell group at the Fraunhofer Institute, is developing a method to identify the bone harming potential in vitro. The stem cell approach promoted by Fraunhofer IZI is characterized by a high predictability for human effects through cost-efficiency and shortened testing periods.

The method will be enabled by simulating and monitoring the multi-phase differentiation process of pluripotent stem cells in a controlled bioreactor system. By adding compounds with known in vivo osteotoxic potential, adverse effects on the differentiation will be identified. Non human embryonic primate stem cells will be compared to human progenitor cells to study varying molecular reactions compared to the established test organisms (mice).

DASGIP will contribute its bioreactor system to the project. Through further improvements Dr. Matthias Arnold, CSO DASGIP, and the scientists at the Fraunhofer IZI plan to establish and automate a multi-step cultivation process covering the different phases of differentiating stem cells in drug testing. Thomas Drescher, President of DASGIP, anticipates providing the industry with a bioreactor system which could help replacing up to 50 percent of the animal tests required in bone toxicity test for drugs, chemicals, plant protecting agents and cosmetics.

DASGIP will contribute its bioreactor system to the project. Through further improvements Dr. Matthias Arnold, CSO DASGIP, and the scientists at the Fraunhofer IZI plan to establish and automate a multi-step cultivation process covering the different phases of differentiating stem cells in drug testing.

The German government subsidizes the research project, acting on behalf of international organizations such as OECD and the EU. Since 1986 the EU commission has stressed its interest in new methods to minimize, replace or optimize animal testing.

Projects of this nature are increasing due to the EU Cosmetics and Chemicals Legislation and the desire to avoid complications associated with drug development. To date, only the embryonic stem cell test (EST) could prove as reliable ex vivo alternative to animal testing, which builds the basis for the planned improvements. The EU commission will publish its new ideas on how to reduce the need for animal testing and how to promote alternative methods in the near future.

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Sperm and eggs from stem cells ‘in 15 years’

Human sperm and eggs will be grown from stem cells within five to fifteen years but the technology will not allow gay and lesbian couples to conceive children with genes from each partner, an international panel of scientists predicted yesterday.

While such artificial gametes (reproductive cells) could be used to treat infertility, the biological barriers to creating sperm from female cells and eggs from male ones will make same-sex conception impossible for the foreseeable future, according to the Hinxton group of leading stem-cell researchers.

Mouse sperm grown from stem cells have already been used to fertilise eggs and produce live pups, and the success has suggested that the technique could allow men and women who make no gametes of their own to have children.

Cells from an infertile man or woman would first be reprogrammed into an embryonic state, or used to make cloned embryonic stem cells. The resulting stem cells would then be turned into sperm or eggs, which would carry the patient’s DNA.

The research has also prompted speculation that sperm could be produced from a woman or eggs from a man, allowing lesbian or gay couples to have children to whom both partners make an equal genetic contribution. Some campaigners who object to the technology have even argued that it could lead to “ultimate incest”, by which a single person becomes mother and father of a child.

Researchers, however, dismissed the prospect of male eggs and female sperm as science fiction in the new Hinxton group report.

Human sex is determined by the inheritence patterns of the X and Y chromosomes: women have two copies of the X, while men have one X and one Y. As several genes that are critical to sperm production are carried on the Y chromosome, this will make it “difficult or even impossible” to turn female cells with two X chromosomes into sperm under any circumstances currently known to science.

The production of eggs from male cells is a little less problematic, but even this is likely to be “very difficult”, the report said.

Professor Robin Lovell-Badge, of the National Institute for Medical Research in London, a member of the group’s steering committee, said: “It would be very difficult to get eggs from XY cells, and even more difficult to get sperm from XX cells – my own view, indeed, is that the latter is impossible.”

Under the Human Fertilisation and Embryology Bill currently passing through Parliament, laboratory experiments with these cells will be permitted, but it will be illegal to use them in fertility treatment.

MPs are expected to table an amendment that would allow Parliament to approve their clinical use in the future, without recourse to primary legislation. Professor Lovell-Badge said he would support such an amendment. An American scientist has suggested that a new method for reprogramming adult cells into an embryo-like state could be used to produce genetically engineered children.

Stem cells produced with the technique could be added to human embryos, so that they developed into “chimeras” that contain cells with two distinct genetic signatures, according to Robert Lanza, of Advanced Cell Technologies.

Other scientists, however, questioned the usefulness of this approach, which would in any case be banned in Britain. Professor Lovell-Badge said: “I cannot think what might be gained by doing this.”

Reproductive cells

— Mouse sperm grown from stem cells have been used to fertilise eggs and produce live pups. All seven of the pups died prematurely, however

— Years more research will be needed to prove it is possible to make human sperm and eggs from stem cells, and to ensure embryos produced are normal

— Scientists expect it to be easier to make sperm from stem cells than eggs

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Clinton On The Issues

The Herald-Dispatch

Stem cell research

Chelsea Clinton said the negative views on stem cell research held by President George W. Bush's administration's exemplify his war on science. Since the current administration has denied stem cell legislation passed by Congress twice before, she said her mother plans on asking Congress, during her first day in office, to reinstitute the stem cell research bill.

Energy technology

Chelsea Clinton said her mother is the last candidate running for presidential office that voted against Bush's 2005 Energy Bill. Her mother plans on investing in areas of research including hydrogen and geothermal energy and driving down the costs of solar and wind technologies. To support clean coal technology, her mother plans on funding 10 different efforts across the county using different types of coal to find out what it takes to produce clean coal technology.

"We absolutely should be using coal to help build our clean energy future," she said.

Americans with Disabilities Act

"The Americans with Disabilities Act is up for renewal this year and my mom thinks that's a real opportunity. ... We know it doesn't adequately protect Americans with mental health disabilities, for instance," she said. "We shouldn't just renewal the Americans with Disabilities Act, but we should extend it."

No Child Left Behind

"(No Child Left Behind) is affecting all of our children's ability to learn. My mother has said that she will unequivocally end the unfunded mandate known as No Child Left Behind," she said.

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Indian American's film on stem cell research for Cannes

New York, March 28: A film by an Indian American doctor that questions the conservative American mindset on stem cell research will be premiered at Cannes soon. Conservative Americans have been opposing stem cell research and describing it as murder.

The film "Hope", based on a novel by Shelley Chawla, a neurologist in Kansas, will be sold at the MIPTV Cannes - an audiovisual and digital content market - in April and at the Cannes Film Market in May.

Partly shot in New Delhi, the film is marketed by Mumbai- and London-based iDream Independent Pictures, known for backing crossover hits like "Monsoon Wedding" and "Bend it Like Beckham", a press release said.

Without stars or frills, Chawla's film tells the story of a powerful US senator who built his career on a conservative platform and is challenged for taking a tough stance against embryonic stem cell research.

The controversy becomes a personal dilemma for the senator when his son is paralysed in a car wreck and he finds that stem cell research work done in India is his only hope for a cure.

Chawla said the movie or his novel, "Hope...in vitro", might not bring an instant resolution of the problem. "But it will certainly throw up a debate and may lead to some conclusion," he said.

He finds it a paradox that stem cell research is forbidden in a scientifically advanced country like the US.

Chawla, 42, came to the US from Punjab after studying medicine.

Kansas-based Rich Ambler has directed the film.

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Experts urge stem cell research reality check

HALF MOON BAY — In an elegant hotel overlooking the Pacific Ocean, more than 30 of the world's leading stem cell researchers gathered Wednesday to strategize on the most effective means of developing novel stem cell medical treatments, while keeping public expectations in line with the actual state of scientific research. The oft-cited potential of stem cells to one day possibly cure devastating ailments such as Parkinson's disease, spinal cord injuries and diabetes is also luring desperate patients to try so-called stem cell therapies abroad, six stem cell researchers at a noon news conference emphasized. This "medical tourism" is almost certain to lead to disappointment and even danger, warned Dr. George Daley, president of the International Society for Stem Cell Research, which organized the daylong event at the Ritz-Carlton hotel. "One has to be realistic. Cures take a very, very long time," Daley said. "One has to be very suspicious if a patient is asked to fly to a distant location and pay tens of thousands of dollars (for treatment). This is an invitation for exploitation."

These unproven treatments, dozens of which are offered online, could also pose medical hazards, Daley said. Another panelist, Sir Ian Wilmut, Ph.D. — the University of Edinburgh scientist who led the team that in 1997 announced the birth of a sheep named Dolly, the first mammal cloned from an adult cell — said that the risk is "serious" that medical tourism for alleged stem cell treatments will continue to expand.

"I've had approaches from people with one of these unpleasant diseases, and I'm not a clinician," said Wilmut. "You would understand that people would be tempted to try anything."

Also sitting on the news conference panel were Dr. Robert Goldstein, chief scientific officer with the Juvenile Diabetes Research Foundation; Robert Klein, chair of the governing body for the California Institute for Regenerative Medicine; Story Landis, Ph.D., chair of the National Institutes of Health's Stem Cell Task Force; and Dr. Olle Lindvall, a neurologist with the University of Lund in Sweden.

The panelists devoted much of their discussion to guidelines the International Society for Stem Cell Research will issue later this year for identifying or developing credible stem cell research initiatives.

"The guidelines are not to prevent the development of stem cell therapy," Lindvall added. "They're actually to help and guide those that are working in a serious way." Wednesday's conference was the first global gathering organized by the society, a premier stem cell research organization with a membership roster that includes the luminaries of the field. During the event sessions, which were closed to the public and the media, participants explored the scientific, clinical, regulatory, ethical and social issues of the complex and promising research.  

Stem cell research, still in its early stages, holds the hope that one day scientists can coax these cells into forming tissue such as nerve cells for treating conditions like Parkinson's disease or central nervous system injuries, pancreatic cells for curing type 1 diabetes, and cardiac muscle for replacing damaged hearts. Stem cells, found in days-old embryos, are capable of developing into any of the more than 200 types of tissue found in the human body. But the field is far from being able to develop these tissues reliably, much less safely transferring them into humans and ensuring they continue to function as programmed.

When more extensive testing with stem cells begins in coming years, public expectations for these early experiments also need to be tempered, stressed Klein, who spearheaded the successful 2004 proposition campaign that led to the creation of the state's Institute for Regenerative Medicine, which funds basic stem cell research. "It's critical for the public to understand that a trial is exactly that," he said. "There will be defeats, and there will be victories." But this promise of tissue transplantation is only one aspect of the value of stem cell research, emphasized Renee Reijo Pera, Ph.D., the director of human embryonic stem cell research at Stanford University's Institute for Stem Cell Biology and Regenerative Medicine.

By developing lab cultures of stem cells, researchers can also study disease processes that will likely speed along drug discovery, she explained. "(Stem cell research) will improve human health, in one or more arenas," predicted Reijo Pera, who didn't attend the conference. Wilmut and Klein enthusiastically agreed that the nearer-term promise for stem cell research lies in its potential for aiding the development of new, valuable drugs by testing them on human cultured cells. "That's a view that I would subscribe to very strongly," Wilmut said. "There's the potential to accelerate drug development and reduce the cost of drug development with human cell lines," agreed Klein.

Underlying the meeting was the message that despite the recent stunning announcement that adult skin cells can be coaxed into reverting into stem cells potentially capable of developing into any human tissue, controversial research on embryonic stem cells must continue for the field to advance.

Due to objections by religious groups and other organizations, the Bush administration in 2001 banned federal funding of embryonic stem cell research, except for 64 stem cell lines already isolated. Researchers state those cell lines have limited research usefulness, and have spearheaded private or state initiatives to fund stem cell research in the United States. Embryonic cells provide a unique window on human development that can't be attained by reversing the pattern in an adult cell, allowing deeper insight into many conditions, such as diseases caused by chromosomal abnormalities, or infertility, said Daley.

"There will never be a time when we don't need human embryo research," Daley said. In February, researchers at the University of California, Los Angeles, reported that by inserting four regulator genes into the DNA of adult skin cells, they induced the cells to reverting back to the stem cells from which they originated.

The results confirmed similar work conducted at Kyoto University and the University of Wisconsin in November. The long-sought results electrified the scientific world, for it meant scientists could sidestep the controversial endeavor of using stem cells derived from embryos to pursue their research.

In addition, the technique potentially allows researchers to create genetically-matched tissue for treating diseases, avoiding the pitfall of a patient rejecting a genetically incompatible transplant. "There is no reason to abandon human embryonic research," said Landis, chair of the federal Stem Cell Task Force. "Over a year ago I testified stating that, and I still have my job," she added with a smile. "You would not want, at this point, to lock any one of those doors."

VistaGen Therapeutics Announces Broad Stem Cell R&D Alliance With Toronto’s University Health Network And The McEwen Centre For Regenerative Medicine

New Sponsored Research Collaboration Expands VistaGen’s Relationship with Dr. Gordon Keller, One of the World’s Leading Stem Cell Researchers

South San Francisco, CA & Toronto - VistaGen Therapeutics, Inc., a biotechnology company using embryonic stem (ES) cell technologies to discover and develop new drugs for diabetes and neurological disorders, announced an expansive ES cell research alliance with Toronto’s University Health Network (UHN), Canada’s leading research hospital, and its stem cell research affiliate, the McEwen Centre for Regenerative Medicine.

The new collaboration positions VistaGen to continue to leverage the ES cell biology expertise and leading-edge ES cell technologies of Dr. Gordon Keller, one of the world’s leading stem cell researchers and the Director of the McEwen Centre for Regenerative Medicine. VistaGen and Dr. Keller expect to conduct research into advanced techniques to differentiate ES cells into mature cardiac, liver, and pancreatic beta-islet cells. This will enhance VistaGen’s industry-leading, in vitro biological systems and bioinformatics databases for predictive toxicology applications.

Collaboration to Benefit Both New Drug Testing and New Drug Development
The new sponsored research program builds on VistaGen’s existing strategic licenses to Dr. Keller’s prior ES cell intellectual property, and covers new ES cell-based research projects.

VistaGen also expects to use the results of this research to develop the next generation of its customized ES cell-based heart, liver and pancreatic beta-islet cell differentiation systems for discovering new drugs to treat heart disease, liver disease and diabetes.

“This collaboration dramatically expands our ES cell R&D programs,” said Dr. Ralph Snodgrass, President and CEO of VistaGen. “Through the new arrangement with UHN and the McEwen Centre, a partnership that builds on our 10-year relationship with Dr. Keller, we expect to develop and commercialize a broad range of next generation stem cell technologies for the pharmaceutical industry. Our team shares the vision of the architects of California’s Stem Cell Initiative, the McEwen Centre, Dr. Gordon Keller, and the other world-class researchers at UHN — that we are at the beginning of an exciting new era where innovative stem cell technologies will give us the tools and approaches to accelerate the discovery and development of safer, more effective new drugs and clinical applications that will make a difference in the lives of millions worldwide.”

“This partnership with VistaGen is an important step toward realizing the founding goals of our Center — to harness the power of stem cell biology and regenerative medicine to develop new treatments for a wide range of life-threatening conditions,” said Dr. Gordon Keller, Director of the UHN’s McEwen Centre for Regenerative Medicine.

“We recognize the need to create effective public-private partnerships to advance UHN’s healthcare mandate. We are pleased our new partnership with VistaGen creates this important linkage with Dr. Keller and his pioneering work in the area of ES cell research, and welcome VistaGen to the growing list of companies establishing strong collaborative linkages with our leading research scientists in the other program areas,” said Dr. Chris Paige, Vice President, Research at UHN. SOOURCE: VistaGen Therapeutics, Inc.

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Brazil court puts off stem cell ruling

BRASILIA, Brazil—Brazil's Supreme Court postponed a decision on whether to permit embryonic stem cell research in Latin America's largest country after one justice asked Wednesday for more time to study the matter.

The court had been scheduled to rule on a 2005 petition by then-Attorney General Claudio Fontelles, who argued that a law passed that same year allowing embryonic stem cell research was unconstitutional because it violates the right to life.

The law opened the way for research with embryos resulting from in-vitro fertilization that have been frozen for at least three years.

The session was suspended, almost five hours after it began, when Justice Carlos Alberto Menezes Direito formally requested more time to consider the issue. He has 10 to 30 days to present his opinion during another session, according to the court's press office.

Before the adjournment, current Attorney General Antonio Fernando Souza and a lawyer for Brazil's Roman Catholic Church argued that embryonic stem cell research should be banned because the process involves destroying embryos, which they said ends human life.

Other attorneys representing the government and Congress defended the 2005 law, saying research with embryonic stem cells could lead to cures of diseases such as Parkinson's, multiple sclerosis and diabetes.

While embryonic stem cell research is currently legal, scientists have put most projects on the back burner pending the Supreme Court's ruling.

Cash boost for stem cell research

Stem cell research aimed at finding a cure for Parkinson's Disease has received a cash boost from a top charity, it has been announced.
The Parkinson's Disease Society (PD) has donated £170,000 to the University of Bristol for research into how to make stem cells produce certain chemicals in the brain associated with the illness.
Scientists in Bristol also aim to develop methods which ensure the cells survive after they are transplanted.
The charity said stem cell therapy may ultimately offer a cure for Parkinson's Disease.
Researchers know symptoms of Parkinson's Disease appear when 80% of the nerve cells in the brain - which make the chemical dopamine - die, the charity said.
The aim of stem cell therapy is to replace the dead dopamine-producing nerve cells with new, healthy cells.
Scientists have already shown stem cells can be grown in the laboratory. But they are yet to ensure cells survive after they are transplanted.
The team at Bristol led by Dr Maeve Caldwell, senior research fellow, will investigate whether they can turn human embryonic stem cells into nerve cells which produce dopamine.
Dr Caldwell said: "If successful, we will then transplant these cells into an animal model that has the symptoms of Parkinson's to see if they are indeed dopamine producing nerve cells which can survive in the brain, even possibly reversing the symptoms of the disease.
"This could be a major step forward in developing an eventual cure for Parkinson's."

Stem cell compromise advances

By: Rick Ruggles and Martha Stoddard , WORLD-HERALD BUREAU

LINCOLN -- Two sides that have disagreed for years over stem cell research appear to have reached a compromise Wednesday.
The Legislature's Judiciary Committee approved a bill that significantly limits such research.

LB 606, which is State Sen. Chris Langemeier's priority bill, will go to the floor of the Legislature.

Speaker of the Legislature Mike Flood of Norfolk said he expects the legislation to be debated and voted on this session, which ends in mid-April.

The Judiciary Committee has struggled with stem cell legislation since last year's session, and the opposing groups have battled over proposed ethical research provisions for several years.

The two sides are the University of Nebraska Medical Center, which conducts some human embryonic stem-cell research, and organizations such as the Nebraska Catholic Conference, Nebraska Right to Life and the Nebraska Coalition for Ethical Research, which say such research that destroys embryos is unethical.

Key provisions of the bill say no state money or state facilities will be used to destroy human embryos for research. Nor will they be used to create an embryo through a technique called somatic cell nuclear transfer, also called therapeutic cloning or research cloning.

What hung up the bill two weeks ago was a section that made it a felony to clone an embryo for the purpose of implanting the embryo into a uterus.

Abortion opponents said that portion of the bill failed to address what some call therapeutic cloning, in which an embryo is killed to create stem cells that theoretically might be used someday to treat various diseases. They argue that killing an embryo is killing a human being and said the failure to address therapeutic cloning in that part of the bill might encourage the private sector to carry out such cloning.

So the Judiciary Committee removed the section altogether.

Both sides on the issue also agreed to pursue no further legislation on embryonic stem cell research or cloning unless the private sector in Nebraska conducts research that kills embryos; research is done with ethical implications not contemplated by either side; and research is conducted in violation of the bill.

Ron Withem, director of governmental relations for the University of Nebraska system, said the bill "allows the core research using embryonic stem cells to continue, consistent with regents guidelines.''

The NU Board of Regents limits UNMC scientists to use of the embryonic stem cell lines that President Bush approved seven years ago. Three UNMC researchers utilize some of those lines.

Withem said the bill is restrictive but acceptable. "And in the face of previous attempts to prevent that research, we view that as a positive step,'' he said.

Greg Schleppenbach, director of pro-life activities for the Nebraska Catholic Conference, praised Flood and State Sens. Steve Lathrop and Brad Ashford, both of Omaha, for their effort to reach a compromise between the two sides.

"It establishes some very important boundaries for biomedical research,'' Schleppenbach said.

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Stem cell scientists explore options

Stem cell research offers the promise of finding cures for some of the most feared and intractable diseases known to man.

A panel of biologists made that case over the weekend to an audience of Bay Area university students, other scientists and members of the community.

Stanford University's Renee A. Reijo Pera, director of the Center for Human Embryonic Stem Cell Research and Education, emphasized the importance of learning more about embryonic development at its earliest stages to realize the therapeutic potential of stem cells.

"It's important that we begin to really understand human development and how cell fate is determined," Pera said. "It's the essence of human embryonic stem cell biology."

Although scientists have learned how to create human embryonic stem cell lines, Pera said, they have yet to learn how to direct those stem cells to morph into specific types of cells that are needed to cure some of the diseases the technology promises to cure.

"Can we direct the fate of the cells?" Pera said. "In most cases, the answer is 'No, we can't do it exactly right.' But we actually are getting a lot closer."

The keynote speech was delivered by Gilberto R. Sambrano, head of the Training Grant Program at the California Institute for Regenerative Medicine. The institute was created in 2004 as a result of state Proposition 71, which charged it with distributing $3 billion of state money for stem cell research.

One of the institute's goals is to develop tangible proof of the principle that transplanted cells derived from stem cells can be used to restore function for at least one disease, Sambrano said.

To address the uncertainty of this relatively new area in science and the amount of money being spent on it, Sambrano pointed to the optimistic mind-set scientists have about it.

"Like any research conducted, it is research and it is a question," Sambrano said. "Do we want to explore it or not, and if we don't explore it, what do we miss out? I guess, until we get there, we don't know. But I think that the potential for it as an enabling technology has excited scientists like nothing has in recent times."

Mary Khan of San Anselmo came to the conference, which was held at Dominican University of California in San Rafael, to learn how far stem cell research has come. Khan's husband suffers from kidney failure.

"My husband is a dialysis patient," Khan said, "and I am trying to research what I think is the only way someone can benefit and ever possibly get help for kidneys, which is to basically to re-grow and re-generate your kidney."

Stem cell research company clones human embryo

Stemagen, a privately held embryonic stem cell research company, announced recently it has become the first in the world to create, and meticulously document, a cloned human embryo using somatic cell nuclear transfer (SCNT).

Stemagen CEO Samuel H. Wood, M.D., Ph.D., a co-author of the publication and a donor of the cells from which the embryos were cloned, terms this achievement "a critical milestone in the development of patient-specific embryonic stem cells for human therapeutic use, potentially including developing treatments for Parkinson's, Alzheimer's and other degenerative diseases." Stemagen's research is exhaustively detailed in a paper published in today's issue of the highly regarded peer-reviewed scientific journal Stem Cells.

"This is not merely a technical improvement on previous research in this area," said Andrew French, Ph.D., lead author on the paper, "Development of Human Cloned Blastocysts Following Somatic Cell Nuclear Transfer (SCNT) with Adult Fibroblasts."

"No other scientific group has documented the cloning of an adult human cell, much less been able to grow it to the blastocyst stage, the stage at which it is the adult donor cell that is driving embryonic development, the stage that yields the cells (the inner cell mass) from which embryonic stem cell lines are made," said French, who is Stemagen's Chief Scientific Officer.

Five blastocysts were developed from 25 donated mature oocytes. Three were confirmed to be clones based on DNA fingerprinting demonstrating the presence of the skin cell donor DNA in the blastocyst, while one was further confirmed to be a clone by an additional mitochondrial DNA (mtDNA) analysis which revealed the presence of oocyte donor mtDNA without any oocyte donor nuclear DNA. For technical reasons, the genetic material in the remaining two blastocysts did not amplify to the extent required for analysis, and so while it is likely they were clones, the evidence required to claim that with certainty was not present. Thus, in this study, cloned blastocysts were successfully created from approximately 10% of all mature donated oocytes, an unexpectedly high rate given past research in this field.

The oocytes used in this study were donated, without compensation, by egg donors and intended parents undergoing egg donation cycles for reproductive purposes at the Reproductive Sciences Center in La Jolla, a leading fertility center specializing in egg donation and other advanced assisted reproductive technologies.

"As important as stem cell research is, all of us involved in this study realized that our overriding responsibility was to the intended parents who entrusted us with their dream of having a child," said Catharine Adams, Ph.D., a co-author on the paper and the laboratory director for Reproductive Sciences Center. "We in the IVF laboratory felt comfortable in this collaboration because we have consistently achieved pregnancy rates of greater than 80 percent from these types of high quality egg donors. In this study, all the intended parents were successful in achieving a pregnancy."

Stemagen and the Reproductive Sciences Center worked closely, over an extended period of time, with a leading independent Institutional Review Board (IRB) to develop procedures ensuring that all parties received comprehensive informed consent and that procedures were in place to protect their confidentiality in the process. All research procedures, including the culturing of the skin cells (fibroblasts) were performed under clinical laboratory conditions in close cooperation with the Assisted Reproductive Technologies (ART) Laboratory of the Reproductive Sciences Center, directed by Catharine Adams, Ph.D. French notes, "An important reason for the success of our SCNT procedures depended on the close coordination between our laboratory personnel and fertility center laboratory staff. Timing is a critical element in maximizing the probability of success in this type of procedure."

Wood points out that this research was exhaustively scrutinized by some of the world's most respected scientists and underwent an exceptionally rigorous process of verification, "This achievement was so critical to our field, we felt we should spare no effort in the process of establishing the validity of our work."

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Cloning Said to Yield Human Embryos

Scientists at a small biotechnology company say they have used cloning to create human embryos from the skin cells of two men.

The work represents a step toward the promise of creating personalized embryonic stem cells that could be used for medical treatments. Although the embryos grew only to a very early stage, the work could also theoretically be seen as a step toward creating babies that are genetic copies of other people.

Scientists at the company, Stemagen, which is based in San Diego, said Thursday that they were the first to use human adult cells to create cloned embryos that advanced to the stage known as a blastocyst, from which embryonic stem cells typically are extracted.

However, the researchers did not derive embryonic stem cells. That left some experts skeptical.

“It’s an important step toward the ultimate goal of making patient-specific stem cell lines via nuclear transfer,” said Dr. George Q. Daley, a stem cell researcher at Harvard and Children’s Hospital Boston, using another term for cloning. But he said skepticism would be erased only when stem cell lines were derived.

Dr. Samuel H. Wood, the chief executive of Stemagen, said the company first wanted to prove it could clone an adult human cell and was now turning to deriving cell lines. “We’ve at least shown the opening to the cave that has the holy grail,” he said.

A paper on the work was published online on Thursday by the journal Stem Cells.

It is not clear whether the embryos would have been viable if implanted into a womb. Stemagen did not test whether the embryos had the correct number of chromosomes. But Dr. Wood, who also is a fertility doctor, said, “We’ve seen reproductive blastocysts that look like this or worse and they implant.”

He said Stemagen, which he started with a wealthy friend in 2005, was not interested in creating cloned babies, something that is illegal in places and morally repugnant to many people. Rather it wants to make stem cell lines for research and medical treatments.

Scientists envision that stem cells created from a clone of a patient could be turned into tissues like brain cells to treat Parkinson’s disease and pancreatic cells to treat diabetes.

But creating stem cell lines through this process, often called therapeutic cloning, has proven difficult.

A company called Advanced Cell Technology created human embryos in 2001 but they died well short of the roughly 100-cell blastocyst stage. In 2004, South Korean researchers led by Woo Suk Hwang reported they had made both cloned embryos and stem cells, but those claims were found to be fraudulent.

Dr. Robert Lanza, chief scientific officer at Advanced Cell Technology, said he was not convinced the blastocysts made by Stemagen were normal, based on the pictures of them in the paper.

But Dr. Daley of Harvard said he found the data “pretty convincing.” He said that since scientists had reported making cloned monkey embryos last November, it was only a matter of time before it could be done for humans.

Cloning is done by removing the nucleus from an egg and replacing it with genetic material from another cell. The egg is then induced into starting to divide as if it had been fertilized by sperm.

The Stemagen scientists, led by Andrew French, an animal cloner recruited from Australia, used skin cells from Dr. Wood and another Stemagen employee as the DNA source. They used 29 eggs donated by young women at the fertility clinic that Dr. Wood manages.

Five blastocysts were developed. One was shown to be a clone by genetic testing, the scientists reported, and two others also showed good evidence of being clones.

Dr. Wood said the key to success might have been choosing egg donors who were known to be fertile and healthy because they had previously been successful donors at his fertility clinic.

The women were also donating at the same time to couples wanting babies. Some eggs went to the couples and the others to the research, with the consent of both the donors and the couples. The donors were paid for the eggs that went to the in vitro fertilization but not to the research, Dr. Wood said.

Therapeutic cloning has been hampered by lack of access to healthy eggs, in part because it is often considered unethical to pay women for such donations. Dr. Daley of Harvard said Stemagen’s “egg sharing” approach appeared to be a reasonable way to obtain eggs.

Scientists in Japan and Wisconsin recently reported being able to make cells that resemble embryonic stem cells without cloning, thereby avoiding the controversial destruction of embryos and the need for eggs. But that new technique has safety risks so some experts say therapeutic cloning is still needed.

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