Stem Cell - Archive

December – September 2009: Stem Cell & Cloning Research

13 Human Embryonic Stem Cell Lines Approved for Research by NIH

Adult Stem Cell Resources – http://www.stemcellresearchfacts.org/

Cord Blood Stem Cells Treat Cerebral Palsy

University of Nebraska Regents Defeat Effort to Limit Embryonic Stem Cell Research

Human Trial of Embryonic Stem Cell Research Stopped Due to Animal Problems / FDA Delays Geron's Human Embryonic Stem Cell Research Trials, Seeks Data

Suit Filed Against NIH to Stop Federal Funding of Destructive Embryo Research

South Korea Seeks Prison Term for Stem Cell Research Fraud Hwang Woo-suk…

Thirteen Embryonic Stem Cell Lines Approved for Research by NIH

Thirteen embryonic stem cell lines were approved Wednesday for federally-funded research with assurance from the director of the National Institutes for Health that research on them is ethical and does not violate principles on human dignity and sanctity of life.

“Let me be clear, these are embryos that would have been otherwise discarded as part of in-vitro fertilization clinic activities,” Dr. Francis Collins noted during an appearance Wednesday on CNN.
[Ed. apparently, that makes it OK to do research on these human embryos — kill them for the sake of research rather than just killing them… Sounds rather like the rationalization used during the Nazi Regime — use them for medical research since they will be killed anyway…]

The NIH director also noted that his federal agency had conducted a “very careful” review of the lines based on the conditions that were set forth in guidelines issued earlier this year and further pointed out that it was former President Bush who first approved the use of stem cell lines for federal researchers to work with.

Notably, however, taxpayer-funded stem cell research under the Bush administration was limited to about 21 embryonic stem cell lines – only those already in existence as of August 2001.

Since then, hundreds of “better lines” have come out, such as the 13 made available Wednesday.
President Barack Obama as he offers remarks Monday, March 9, 2009, in the East Room of the White House before the signing of the Stem Cell Executive Order and Presidential Memorandum on Scientific Integrity. (Photo credit: Pete Souza)

President Barack Obama as he offers remarks Monday, March 9, 2009, in the East Room of the White House before the signing of the Stem Cell Executive Order and Presidential Memorandum on Scientific Integrity. (Photo credit: Pete Souza)

The NIH’s announcement marked the first time new lines were made available since President Obama lifted the restriction set by Bush that made research on lines created after August 9, 2001, ineligible for federal funding.

According to Collins, another 96 embryonic stem cell lines are currently undergoing NIH review, and 20 or more could get a decision by Friday. Researchers have also notified the NIH that they may apply for approval of another 250 stem cell lines.

Though embryonic stem cells have been highly touted for their potential to lead to breakthroughs in curing diseases such as Parkinson’s, cancer, and paralysis, among others, critics of embryonic stem cell research say lifting the ban on their federal funding could open the door to future abuses and paste “a veneer of ‘ethics’” on unethical experiments.

Critics also point out that embryonic stem cell research has yielded no cures to date. Adult stem cells and neonatal stem cells, meanwhile, have been used in successfully treating over 100 diseases without controversies and have been hailed by some as having many superior qualities to embryonic stem cells.

In his appearance on CNN, Collins acknowledged the lack of progress in the relatively new field but noted that it’s partly because of the limits that have been placed on the research.

“We really don’t know what the potential is here,” he reported. “And I want to be clear that we should be careful not to overstate the likelihood that this approach is going to result in breakthroughs in those diseases. But it is certainly an exciting new pathway.”

Despite the uncertainty, Collins made clear that he believes that it’s far more beneficial to utilize what would otherwise be discarded.

“The embryos are being created anyway with a benevolent purpose to try to give a childless couple a chance to have a baby. It does seems to me, as a believer, as a Christian, that it’s more ethically acceptable – as long as the consent process was carefully followed and it’s clear that no payment was involved, there was not coercion involved. It was the free gift of the donors to make this available for research. That seems to me to measure up to ethical standards that are quite defensible from whatever your worldview,” he stated.

In continuing, Collins said: “The question that many ethicists have posed and people both of faith and people who come at it from a different perspective have concluded that in fact, ethically, isn’t it more justifiable if those embryos that have been created to use them for a purpose that might help someone with a disease as opposed to simply discarding them?

“It seems to me with that kind of argument, even those who feel strongly about the sanctity of life, when asked to balance the pros and cons of discarding versus trying to do something useful to honor that particular source of human material would say ‘Maybe we’re better off doing what we’ve done,’” he added.

With Wednesday’s announcement, researchers who were awarded $21 million in stem cell research grants earlier this year can start using the approved lines immediately. Millions more in stem cell money, meanwhile, is due out later this winter.
[3Dec09, The Christian Post, Eric Young, http://www.dakotavoice.com/2009/12/thirteen-embryonic-stem-cell-lines-approved-for-research-by-nih/]

 

 

New Site for Adult Stem Cell Resources
A new Web site is detailing success stories in adult stem cell research. http://www.stemcellresearchfacts.org/ is part of a campaign to educate and spread awareness about the potentials and successes of adult stem cell therapies. It was created by the Family Research Council and is just the first phase of the project. It includes three videos that present the stories of people who have been saved or helped by adult stem cells.

Amy Daniels tells how she has survived systemic scleroderma. The parents of Joseph Davis tell how their second child was able to save Joseph from sickle cell anemia. And Laura Dominguez af

firms that thanks to adult stem cells, she is going to walk again after a car accident that left her paralyzed. The new site was launched Saturday in Kansas City. http://www.zenit.org/rssenglish-27581

 

 

Cord Blood Stem Cells Treat Cerebral Palsy–And a Potential Problem For Regenerative Medicine Overall – Wesley J. Smith
http://www.firstthings.com/blogs/secondhandsmoke/2009/11/18/cord-blood-stem-cells-treat-cerebral-palsy-and-a-potential-problem-for-regenerative-medicine-overall/

 

 

University of Nebraska Regents Defeat Effort to Limit Embryonic Stem Cell Research
The University of Nebraska board of regents today defeated an effort to limit the embryonic stem cell research activity that takes place there because it involves the destruction of unborn human life. The current school policy is to engage in research allowed by the federal government, which includes ESCR.

The eight-member Board of Regents voted 4-4, which defeated the resolution that would have limited research to older embryonic stem cell lines and focused on adult stem cell research, the only kind to ever help patients.

Regent Jim McClurg of Lincoln cast the deciding vote against the resolution. He had the endorsement of Nebraska Right to Life when he was elected to the board in 2006 but appeared to have turned on the pro-life group today.

NU President J.B. Milliken addressed the regents and urged a no vote while Dr. John Safranek, a Nebraska physician, said the research is wrong because it destroys human life.

The vote came after the passage last year of a bill that some claim is a compromise between pro-life advocates and the University of Nebraska board that prohibits using state resources to create or destroy human embryos for research.

However, pro-life advocates did not view it as such and, this week, the Nebraska Coalition for Ethical Research delivered 6,873 petitions to the regents calling for more limits.

Chip Maxwell, executive director of the group, informed LifeNews.com that it also delivered a letter from 255 Nebraska physicians, researchers and medical professionals urging the regents to block expansion of human embryonic stem cell research at the college.

They explain that from a medical research perspective, embryonic stem cell research is not ethical and is not necessary for progress in stem cell research.

"It disproves the assertions that the Nebraska legislature said yes to expansion of embryonic stem cell research by passing LB 606 in 2008, and that the voting public supports it," Maxwell said.

The delivery of the petitions came after Nebraska Right to Life and other state pro-life groups recently asked the University of Nebraska Board of Regents to revisit its current policy on embryonic stem cell research.

Nebraska Right to Life director Julie Schmit-Albin told LifeNews.com at the time, "Our opponents have been touting the 'agreement' with LB 606 as the definitive statement on unethical research policy in the state."

"The three senators most involved in the compromise behind LB 606 confirm what we have been saying all along, that LB 606 did not settle the policy of the Board of Regents which is a separate governing entity," Schmit-Albin continued.

"This coupled with documentation provided that Nebraska Research PAC was heavily involved in at least one Regent's race in 2008, should put to rest the notion that LB 606 resolved the matter for the Regents," she said

Related web sites:
Nebraska Coalition for Ethical Research – http://www.EthicalResearch.net

Nebraska Right to Life – http://www.nerighttolife.org

[20Nov09, Lincoln, NE, http://www.lifenews.com/bio3006.html]

 

 

Human Trial of Embryonic Stem Cell Research Stopped Due to Animal Problems
More information is coming to light about why the Food and Drug Administration has made the decision to stop human trials involving embryonic stem cells. The reasons mirror the concerns pro-life advocates have had for years with the research, which has yet to help any patients.

Geron Corporation had applied for permission to try injections of embryonic stem cells, which can only be obtained by destroying the lives of unborn children at their earliest stage of life, in humans.

But pro-life advocates said they didn't think it would work because of problems in animals.

When used in animal research, injections of embryonic stem cells formed tumors afterwards and also prompted the immune system of the intended recipients to reject the cells.

The FDA delayed the trials to review studies of the therapy, called GRNOPC1, in its use with animals.

Now, new reports indicate problems associated with the animals in Geron's studies prompted the FDA to halt the human trials. Specifically, the animals developed cysts at the injury sites after the injections.

Geron tried to play down the concerns and said in a statement that “a very low frequency of injected animals developed microscopic cysts in the regenerating injury site” but the cysts were “non-proliferative, confined to the injury site, and had no adverse effects on the animals."

It added that none of the animals developed teratomas.

“We have submitted these data to the FDA and are in discussions with the agency to answer its questions and proceed with the clinical trial,” Geron said.

Wesley J. Smith, a bioethicist, says he thinks the research done on humans using cells from aborted babies showed eventual problems and he believes the FDA needs to significantly slow down Geron's plans to proceed quickly.

"You know, tumors formed in a child given fetal cell treatments three years after the injection, and so I wonder how long an animal would have to be followed to determine safety," he said.

"And we can't forget that the company apparently has not tested the product in large animals, and so there is some swimming in the dark here," he added. "Nevertheless, the FDA did the right thing here in terms of pure safety."

Geron had planned to begin the trials this summer but said it will halt that pending the FDA review and did not know how long it would take the regulatory agency to conduct its evaluation.

The FDA initially cleared the trials in January, which would involve 8 to 10 patients.

Embryonic stem cell research has never cured or helped any patients to this point. Only the use of adult stem cells and treatments derived from them have cured or reduced the effects of any diseases or conditions afflicting patients.

Geron Corp., based in California, will use the treatment with 10 spinal cord patients with injuries the company hopes to treat with an experimental drug containing embryonic stem cells.

The patients in the trial will be ones who can receive treatment within 14 days after a spinal cord injury has left them paralyzed. They will need to be followed for a year to determine if the treatments had any effect.

Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, warns that the research may not be ready for humans.

"There's a lot of debate among spinal cord researchers that the pre-clin

ical data itself doesn't justify the clinical trial," Snyder, who is working on using neural stem cells himself, says.

Snyder says the mice Geron used to conduct pre-human trial research had more excessive injuries that scientists would normally prefer to see prior to trying the procedure on human patients.

He suggests that Geron should have done experiments involving larger animals before seeking FDA permission to use the controversial embryonic stem cells in humans.

Those concerns existed as early as 2005 and may not have been addressed.

Snyder said then that Geron should do more animal testing first to make sure the tests would be on the same injuries humans have.

"I'm not convinced they have done that yet," Snyder said.

Jerry Silver, a neuroscience professor and stem-cell researcher at Case Western Reserve University in Cleveland, told Knight Ridder back in November 2005 that Geron was moving too fast and needed to do more tests on animals before seeking human patients.

"Frankly, I cannot conceive of a human trial with the use of human embryonic stem cells following immediately from experiments in rodents only," he said then. "Many treatments that work in rodents to alleviate disease fail miserably in humans."
[27Aug09, Ertelt, LifeNews.com, Washington, DC,  http://www.lifenews.com/bio2940.html ]

 

FDA Delays Geron's Human Embryonic Stem Cell Research Trials, Seeks Data
 The Food and Drug Administration is delaying a bid by biotech company Geron to become the first to conduct human trials with embryonic stem cells. These trials would involve the destruction of human life.

Geron officials said today that the FDA is reviewing new data from studies of the therapy, called GRNOPC1, in its use with animals. Scientists and pro-life advocates say human embryonic stem cells are not ready for trial because problems associated with the cells in animals haven't been solved.

The embryonic stem cells still cause tumors and have issues with the immune system rejecting the injection of the cells. Geron had planned to begin the trials this summer but said it will halt that pending the FDA review and did not know how long it would take the regulatory agency to conduct its evaluation.

The FDA initially cleared the trials in January, which would involve 8 to 10 patients. Embryonic stem cell research has never cured or helped any patients to this point. Only the use of adult stem cells and treatments derived from them have cured or reduced the effects of any diseases or conditions afflicting patients. [18August09, www.LifeNews.com]

 

 

 

 

Suit Filed Against NIH to Stop Federal Funding of Destructive Embryo Research. A lawsuit filed yesterday in the United States District Court for the District of Columbia seeks to overturn the controversial guidelines for public funding of embryonic stem cell research that the National Institutes of Health issued on July 7, 2009.

The implementation of these guidelines marks the first time that taxpayer dollars will be used to fund research that will result in the destruction of human embryos. Since 1994, Congress has expressly banned NIH from funding research in which human embryos "are destroyed, discarded, or knowingly subjected to risk of injury or death."

According to Thomas G. Hungar, one of the lawyers for the plaintiffs, "the language of the statute is clear. It bans public funding for any research that leads to the destruction of human embryos. NIH's attempt to avoid Congress's command by funding everything but the act of 'harvesting' is pure sophistry. The guidelines will result in the destruction of human embryos and are unlawful, unethical, and unnecessary."

The plaintiffs contend that the NIH guidelines violate the congressional ban because they "necessarily condition funding on the destruction of human embryos." In addition, the plaintiffs also allege that the NIH guidelines were invalidly implemented, because the decision to fund human embryonic stem cell research was made without the proper procedures required by law and without properly considering the more effective and less ethically problematic forms of adult and induced pluripotent stem cell research.

President Obama, in announcing his Administration's policy stated he was determined to fund ethically "responsible, scientifically worthy human stem cell research…to the extent permitted by law."

However, the plaintiff's contend that the NIH guidelines, while claiming to "implement" the President's directions, fail his own test because they are not only unlawful, but they are based upon an ethically irresponsible misunderstanding of available scientific evidence.

One of the expert stem cell researcher plaintiffs, Dr. James L. Sherley, explained that "the great irony of the guidelines is that research involving stem cells safely derived from human adults and other sources presents the same if not greater potential for medical breakthroughs, without any of the troubling legal and ethical issues related to embryonic stem-cell research." Clinical trials using adult stem cells have successfully reversed the effects of diseases such as lupus, multiple sclerosis, and rheumatoid arthritis. The plaintiffs argue that because NIH promulgated its guidelines with a preconceived determination to fund human embryonic stem cell research and without considering these scientifically and ethically superior alternatives, the guidelines are invalid regulations and should be struck down.

Dr. David Stevens, Executive Director of Christian Medical Association, an organization of more than 16,000 doctors who are also plaintiffs in the case, said "we are opposed to this proposed illegal and unethical federal funding of destructive embryonic research that would compel every American to cooperate with such unlawful human experimentation and the violation of our fundamental medical research ethic never to lethally experiment on one human being simply to benefit the interests of other human beings."

Co-counsel for the plaintiffs, Sam Casey, General Counsel of Advocates International's Law of Life Project, a public interest legal project, added: "The majority of the almost 50,000 comments that the NIH received were opposed to funding this research, and by its own admission, NIH totally ignored these comments. The so-called spare human embryos being stored in IVF clinics around the United States are not 'in excess of need,' as the NIH in its guidelines callously assert. They are human beings in need of biological or adoptive parents."

The lawsuit is brought by a broad coalition of plaintiffs, including Dr. James L. Sherley, a former member of the MIT faculty; Dr. Theresa Deisher, the founder, managing member, and research and development director of AVM Biotechnology; Nightlight Christian Adoptions, a non-profit, licensed adoption agency dedicated to protecting and finding adoptive parents for human embryos conceived through in vitro fertilization; all individual human embryos whose lives are now at risk under NIH's guidelines; parents seeking to adopt human embryos; and the Christian Medical Association, a non-profit association of doctors dedicated to improving ethical standards of health care in the United States and abroad.

The Alliance Defense Fund, a legal alliance of Christian attorn

eys and like-minded organizations defending religious freedom and the sanctity of human life, is also serving as co-counsel on the case and providing financial support.
WASHINGTON, Aug. 20, 2009 (LifeSiteNews.com]

 

 

 

South Korea Seeks Prison Term for Stem Cell Research Fraud Hwang Woo-suk South Korea officials told a court on Monday that they want disgraced embryonic stem cell research scientist Hwang Woo-suk to face four years for allegedly engaging in fraud.

Hwang became an international embarrassment after he admitted to faking supposed advances in the science that involves the destruction of human life. In the studies his team conducted, Hwang claimed to have created the first cloned human embryo and claimed to have created patient-matched embryonic stem cells that would overcome immune system rejection issues. Those would have been big advances since embryonic stem cells have yet to help a single human patient and have encountered numerous problems when used in animals.

Hwang and some of his top colleagues were indicted in May 2006 by South Korean prosecutors and charged with fraud, embezzlement and violating bioethics rules. He faces potential jail time as a result of allegations of widespread embezzlement of $2.8 million in public research funds. [25Aug09, www.LifeNews.com, Seoul, South Korea]