Stem Cell Buzz May Help Industry

Stem cell companies may benefit from the buzz surrounding the field generated by the anticipated clash between Congress and President Bush and increased regulatory attention being given to adult stem cell products.

Companies focused on embryonic stem cell therapeutics have issued releases about their research recently in an apparent attempt to capitalize on the increased attention on the field after the House passed legislation last week that would relax restrictions on federal funding for the research.

Both chambers of Congress passed a similar bill last year, but Bush vetoed it and is expected to continue his opposition this year. House Democrats last week were hopeful they could garner enough votes to override a veto, but they fell short of the votes they would need to do so.

Advanced Cell said Wednesday it plans to hold a conference for investors on Friday to "to discuss recent progress and events with respect to the company's initiatives to develop stem cell-based therapies for a range of diseases and conditions."

Geron said Wednesday new research indicates GRNOPC1, a potential human embryonic stem cell-based therapeutic for spinal cord injury, produces multiple nerve growth factors that stimulate survival and regeneration of damaged neurons in animal models.

The FDA issued a draft guidance for a streamlined path to licensure for cord blood products for certain medical conditions, such as replenishing the bone marrow in patients with leukemia.

"Cord blood hematopoietic stem/progenitor cells offer the potential for tremendous therapeutic benefit," said Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "In this draft guidance, FDA provides recommendations on a streamlined path to licensure for these promising products that also ensures their safety and effectiveness."

Under the draft guidance, cord blood banks can cite existing data in the docket to support licensure for certain indications rather than having to provide their own clinical data. The FDA said it was proposing this strategy because it has determined cord blood hematopoietic stem/progenitor cells are safe and effective for certain indications based on data submitted to the public docket and published scientific research.

Advanced Cell said during its Friday conference call William Caldwell IV, its chairman and chief executive officer, will provide an overview of the company's activities and will comment on the effect the political climate is having on stem cell research.

This includes not only the federal debate, but favorable legislation for the research passed by certain states, such as California and New Jersey. Advanced Cell also noted that Eliot Spitzer, who was recently elected governor of New York, called for passage of a research-and-development bond that would provide $2 billion over a 10-year period, at least half of which would go towards stem cell work.

Cloning Seen as Abortion-like Issue

Sen. Tim Huelskamp, R-Fowler, proposed to ban taxpayer-funded research with embryonic stem cells, during a Senate debate on Wednesday. He attempted to limit his proposal to $11.7 billion state budget for the fiscal year beginning July 1, which failed.

Rep. Mary Pilcher Cook, R-Shawnee, got the approval of a proposal for research with adult stem cells or umbilical cord blood, as alternatives to embryonic stem cells. She failed to add a proposal to make it a felony to create or attempt to create human-animal hybrids.

Huelskamp and Pilcher Cook are abortion opponents. Their ideas have the support of Kansans for Life, the state's largest anti-abortion group.

This type of proposals worry some legislators, who fear that anti-cloning legislation could be written in such a way to damage a new biosciences industry in the Kansas City area.


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Michigan - Debate Over Stem Cell Research Limits

Lansing, Michigan, is holding a debate over lifting the prohibition on the use of human embryos to develop stem cells for research.

The proponents of a legislation that would permit the use of embryos to create stem cells for research mentioned the unlimited medical benefits and the economic benefits of encouraging high-tech business.

The opponents think that the claims are wildly exaggerated and that lifting the ban would give state sanction to the cloning of human beings for the express purpose of destroying them.

Under current law, researchers in Michigan may develop adult stem cells and experiment on embryonic stem cells imported into the state. But supporters of the legislation said those limits make Michigan uncompetitive with states like Illinois and California, which subsidize embryonic stem cell research...

Debate Over Stem Cell Research Limits

New Jersey to Borrow $50 million More for 3rd Facility

A bill amended by the Senate Monday is adding funds to build an institute in Newark for studying adult stem cells.

This means that New Jersey would borrow $50 million in addition to $150 million earmarked for a New Brunswick-based institute and $50 million slated for a biomedical research center in Camden. The money would come from borrowing against future cigarette taxes.

The Assembly Health and Senior Services Committee has passed its version of the amended bill by a 9-2 vote. The bill includes the new New Jersey Institute of Technology, though not the added funds. Instead it allocates $50 million from the New Brunswick facility to the Newark facility.

Maryland House and Senate Trade Blows Over Stem Cell Research

Highlighting the debate in Maryland, both the state Senate and House have approved significantly different bills funding research on stem cells taken from human embryos.

Barely a month is left for regional decision makers to resolve their differences.

Maryland Senate leaders hope the House will accept their bill so that any additional legislation doesn't have to return to the Senate floor.

"Part of the House's thinking should be the difficulty in this body," said Senate President Thomas V. Mike Miller, D-Calvert, who had to work hard to get the votes to shut off a short-lived filibuster Wednesday.

House Speaker Michael Busch, stated that following Wednesday's vote major flaws are within the Senate bill. He specifically pointed to the the fact that it does not require that any money be provided for stem cell research.

The House bill would provide $25 million a year in the state budget for stem cell research grants without administrative controls. However, Senate's bill would permit the governor to decide whether money would be appropriated and how much.


Stem cell bill passes Senate; future uncertain

California Stem Cell Initiative In Judges Hands

California's $3 billion stem cell research program is now dependant upon Alameda County's Superior Court which will rule if the program is constitutional after March 15th.

A ruling by Judge Bonnie Sabraw is not expected to end current fighting over the program. Both sides of the stem cell controversy predict the case is to be appealed to the California Supreme Court.

In all likelyhood, this means it could be months before the stem cell agency can issue bonds to begin financing research. Even if the stem cell agency receives a favorable ruling from Sabraw. Investors will not want to purchase bonds while appeals are pending.

Read more in California - Stem cell program in judge's hands

Cloned Human Embryos Seen Inevitable

"The past, present and future of stem cell research was the focus of a St. Louis news briefing on Friday at the annual meeting of the American Association for the Advancement of Science — the very same forum where Hwang made such a splash in 2004."

Ethicists are gearing up for a new wave of social and political debate while stem cell researchers are getting over their deep disappointment concerning last year's scandal over faked cloning experiments in South Korea, and moving ahead with new discoveries.

Scientists on both sides of the debate said that it's likely just a matter of time before someone really does produce stem cells from cloned human embryos

"Probably over the next couple of years, this will be done," said Leonard Zon, a stem cell researcher at Children's Hospital in Boston. "I think the individual steps are solvable."

Some of the speakers at Friday's forum still felt stung by the affair — not only because they were misled, but because it turned out that Hwang's female subordinates were pressured to donate their own eggs. Northwestern University bioethicist Laurie Zoloth said anyone who played even an inadvertent role in Hwang's deception, including herself as well as the research community and even science journalists, should join in a mass apology...


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