Saturday, March 21, 2009
Wednesday, March 11, 2009
Some states push back against stem cell research
Some states push back against stem cell research
By SHANNON McCAFFREY, Associated Press Writer Shannon Mccaffrey, Associated Press Writer 1 hr 31 mins ago
ATLANTA – A showdown is shaping up in some of the nation's most conservative states over embryonic stem cell research, as opponents draw language and tactics from the battle over abortion to counter President Barack Obama's plan to ease research restrictions.
Legislation granting fertilized embryos "personhood" has gained momentum in at least three state legislatures. The strategy — which has been used to try to undermine the Roe v. Wade decision legalizing abortion — is now aimed at embryonic stem cell research. The scientific field uses stem cells from human embryos, which can develop into different kinds of adult cells, to seek answers about human health.
Opposition to both abortion and stem cell research hinges on the same issue: When does life begin? As a result, embryonic stem cell research has become the latest front in the decades-old battle over abortion.
"If you are someone who believes that a single cell embryo is a person then you are looking for any opportunity you can to make that argument. But as a country, legally, we've never accepted that," said Michael Werner of the Coalition for the Advancement of Medical Research. "The legislative tactics are the same."
Abortion opponents believe embryonic stem cell research is an assault on life in its earliest form. Fertilized embryos are destroyed when stem cells are extracted from them for research.
"No one's right for a cure supersedes someone else's right to life," said Dan Becker, president of Georgia Right to Life.
The opponents expect to push for restrictions in conservative-leaning states. And they say states must take the lead in pushing the abortion and stem cell issues into the increasingly conservative federal courts.
Legal experts said the state measures restricting stem cell research raise constitutional concerns in a largely untested area of law.
Alta Charo, professor of law and bioethics at the University of Wisconsin, said a new line of legal thought holds that scientific inquiry should be protected by the First Amendment, "like a political or religious statement or activity."
She said the measures restricting the use of fertilized embryos also raise questions about the right to procreation.
"The courts haven't settled this yet," Charo said.
While Louisiana already bans the destruction of fertilized embryos, the courts have not yet weighed in, Charo said.
In Georgia, a measure that would ban some forms of stem cell research on fertilized embryos is moving quickly through the state Senate. The bill would outlaw the destruction of fertilized embryos, which the legislation defines as a person. It is expected to face a vote in the full state Senate on Thursday.
Similar "personhood" measures have cleared one chamber each in Montana and North Dakota.
They come in the wake of a Colorado ballot initiative that said human life begins at conception. It failed to win voter approval last year.
David Prentice, senior fellow for life sciences at the Washington, D.C.-based Family Research Council, said Obama's announcement Monday that he will free federal funds for embryonic stem cell research will rally conservatives.
"This is the beginning," Prentice said. "I think there will be more to come."
In 2001, President George W. Bush limited federal funding for embryonic stem cell research to 21 stem cell lines already in existence. Because they were already being used for research, Bush allowed work on them to continue.
Obama's new approach will enable federally funded researchers to use hundreds of new embryonic stem cell lines. Supporters believe the research could lead to treatments for major disorders, such as Parkinson's disease and spinal injuries.
Eight states bucked the Bush administration limits and allowed state money to be spent on the research: California, Connecticut, Illinois, Iowa, Maryland, Massachusetts, New Jersey and New York.
Some of them, struggling with gaping budget deficits, may rein in state funding for those research programs, now that federal dollars will again be flowing.
Sean Tipton, director of public affairs at the American Society for Reproductive Medicine, said legislation that would affect stem cell research has been introduced in several states, including Alabama, Georgia, Maryland, Montana, North Dakota and South Carolina.
"It's clearly part of a national strategy and at some point it will probably succeed," Tipton said.
Tipton said advocacy groups are targeting states where they have the best chance of success.
One of those is Georgia, where Gov. Sonny Perdue has said he opposes embryonic stem cell research, even as he tries to lure biotech companies to state.
"I am absolutely opposed to creating embryos to cure a disease," Perdue told reporters this week.
The Georgia bill cleared the Senate Health and Human Services Committee by a close 7-6. The religious conservatives pushing it are influential with Georgia's Republican-led Legislature.
Opponents say the Senate bill would be a blow to the state's thriving research universities, as well as fertility clinics that perform thousands of in-vitro treatments every year.
"We have the president of the United States saying he is going to put science ahead of politics and unfortunately in Georgia we are moving in the opposite directions," said state Sen. David Adelman, a Democrat from Decatur.
___
National Conference of State Legislatures Genetic Technologies Project: http://www.ncsl.org/programs/health/genetics
By SHANNON McCAFFREY, Associated Press Writer Shannon Mccaffrey, Associated Press Writer 1 hr 31 mins ago
ATLANTA – A showdown is shaping up in some of the nation's most conservative states over embryonic stem cell research, as opponents draw language and tactics from the battle over abortion to counter President Barack Obama's plan to ease research restrictions.
Legislation granting fertilized embryos "personhood" has gained momentum in at least three state legislatures. The strategy — which has been used to try to undermine the Roe v. Wade decision legalizing abortion — is now aimed at embryonic stem cell research. The scientific field uses stem cells from human embryos, which can develop into different kinds of adult cells, to seek answers about human health.
Opposition to both abortion and stem cell research hinges on the same issue: When does life begin? As a result, embryonic stem cell research has become the latest front in the decades-old battle over abortion.
"If you are someone who believes that a single cell embryo is a person then you are looking for any opportunity you can to make that argument. But as a country, legally, we've never accepted that," said Michael Werner of the Coalition for the Advancement of Medical Research. "The legislative tactics are the same."
Abortion opponents believe embryonic stem cell research is an assault on life in its earliest form. Fertilized embryos are destroyed when stem cells are extracted from them for research.
"No one's right for a cure supersedes someone else's right to life," said Dan Becker, president of Georgia Right to Life.
The opponents expect to push for restrictions in conservative-leaning states. And they say states must take the lead in pushing the abortion and stem cell issues into the increasingly conservative federal courts.
Legal experts said the state measures restricting stem cell research raise constitutional concerns in a largely untested area of law.
Alta Charo, professor of law and bioethics at the University of Wisconsin, said a new line of legal thought holds that scientific inquiry should be protected by the First Amendment, "like a political or religious statement or activity."
She said the measures restricting the use of fertilized embryos also raise questions about the right to procreation.
"The courts haven't settled this yet," Charo said.
While Louisiana already bans the destruction of fertilized embryos, the courts have not yet weighed in, Charo said.
In Georgia, a measure that would ban some forms of stem cell research on fertilized embryos is moving quickly through the state Senate. The bill would outlaw the destruction of fertilized embryos, which the legislation defines as a person. It is expected to face a vote in the full state Senate on Thursday.
Similar "personhood" measures have cleared one chamber each in Montana and North Dakota.
They come in the wake of a Colorado ballot initiative that said human life begins at conception. It failed to win voter approval last year.
David Prentice, senior fellow for life sciences at the Washington, D.C.-based Family Research Council, said Obama's announcement Monday that he will free federal funds for embryonic stem cell research will rally conservatives.
"This is the beginning," Prentice said. "I think there will be more to come."
In 2001, President George W. Bush limited federal funding for embryonic stem cell research to 21 stem cell lines already in existence. Because they were already being used for research, Bush allowed work on them to continue.
Obama's new approach will enable federally funded researchers to use hundreds of new embryonic stem cell lines. Supporters believe the research could lead to treatments for major disorders, such as Parkinson's disease and spinal injuries.
Eight states bucked the Bush administration limits and allowed state money to be spent on the research: California, Connecticut, Illinois, Iowa, Maryland, Massachusetts, New Jersey and New York.
Some of them, struggling with gaping budget deficits, may rein in state funding for those research programs, now that federal dollars will again be flowing.
Sean Tipton, director of public affairs at the American Society for Reproductive Medicine, said legislation that would affect stem cell research has been introduced in several states, including Alabama, Georgia, Maryland, Montana, North Dakota and South Carolina.
"It's clearly part of a national strategy and at some point it will probably succeed," Tipton said.
Tipton said advocacy groups are targeting states where they have the best chance of success.
One of those is Georgia, where Gov. Sonny Perdue has said he opposes embryonic stem cell research, even as he tries to lure biotech companies to state.
"I am absolutely opposed to creating embryos to cure a disease," Perdue told reporters this week.
The Georgia bill cleared the Senate Health and Human Services Committee by a close 7-6. The religious conservatives pushing it are influential with Georgia's Republican-led Legislature.
Opponents say the Senate bill would be a blow to the state's thriving research universities, as well as fertility clinics that perform thousands of in-vitro treatments every year.
"We have the president of the United States saying he is going to put science ahead of politics and unfortunately in Georgia we are moving in the opposite directions," said state Sen. David Adelman, a Democrat from Decatur.
___
National Conference of State Legislatures Genetic Technologies Project: http://www.ncsl.org/programs/health/genetics
European Commission Awards Orphan Designation to Knopp Neurosciences' KNS-760704 in ALS
European Commission Awards Orphan Designation to Knopp Neurosciences' KNS-760704 in ALS
PITTSBURGH--(BUSINESS WIRE)--Knopp Neurosciences Inc. ("Knopp") today announced that the European Commission ("EC") has designated KNS-760704 as an orphan medicinal product for the treatment of Amyotrophic Lateral Sclerosis.
The EC decision, based on a favorable opinion from the European Medicines Agency (EMEA), follows the designation of KNS-760704 as an orphan drug for the treatment of ALS by the U.S. Food and Drug Administration in 2007. KNS-760704 is currently in Phase 2 clinical trials for ALS, a universally fatal neurodegenerative disease with limited treatment options.
"We are very pleased with the European Commission's designation of KNS-760704 as an orphan medicinal product and the recognition of its potential to be of significant benefit for patients with ALS," said Michael Bozik, M.D., president and CEO of Knopp. "Orphan medicinal product designation will significantly facilitate our efforts to develop a safe and effective treatment for patients suffering from this relentless disease."
To stimulate the research and development of orphan drugs, the European Union ("EU") has established a centralized procedure for the designation of orphan medicinal products and provides incentives for the development of medicinal products for rare disorders. Companies with an orphan designation for a medicinal product benefit from incentives that include fee reductions, a 10-year market exclusivity period following authorization for designated products, scientific advice to optimize development, and direct access to the EMEA centralized procedures for marketing authorization.
Knopp plans to initiate Phase 3 development of KNS-760704 in ALS in late 2009.
About KNS-760704
KNS-760704 is a low molecular weight benzothiazole shown to improve mitochondrial function and confer significant cellular protection in neurons under stress. The chirally pure form of the synthetic benzothiazole (6R)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole, KNS-760704 is highly orally bioavailable, water soluble, renally excreted, and only moderately protein bound. In Phase 1 studies, the compound was shown to be safe and well tolerated in healthy human subjects. Phase 2 studies of KNS-760704 in ALS are ongoing. The compound has received orphan drug designation from the U.S. Food and Drug Administration and the European Commission for the treatment of patients with ALS.
About ALS
Amyotrophic lateral sclerosis, also known as Lou Gehrig's disease and Charcot's sclerosis, is a rapid, universally fatal neurodegenerative disorder characterized by progressive muscle weakness and wasting. ALS affects adults in the prime of life and creates a substantial burden for caregivers. U.S. prevalence is approximately 20,000 and the global incidence is approximately two per 100,000. Only one drug has been approved for the treatment of ALS. Life expectancy after symptom onset is usually three to five years.
About Knopp Neurosciences Inc.
Knopp Neurosciences is a drug discovery and development company focused on delivering breakthrough treatments for neurological disorders through innovation, experience, and partnership. The company's lead product candidate is KNS-760704, an orally bioavailable small molecule in development for the treatment of ALS. Knopp's leadership includes experienced neuroscience drug development and discovery executives formerly associated with major pharmaceutical companies. Knopp's financing has been led by Saturn Capital Inc. of Boston as placement agent and Saturn Partners II as lead funder.
This press release contains "forward-looking statements," including statements relating to Knopp's planned regulatory filings and clinical development programs for KNS-760704. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the uncertainties inherent in clinical trials and product development programs, the availability of funding to support continued research and studies, the availability or potential availability of alternative therapies or treatments, the availability of patent protection for the discoveries and strategic alliances, as well as additional factors that may cause Knopp's actual results to differ from our expectations. There can be no assurance that KNS-760704 will be successfully developed or manufactured or that final results of clinical studies will be supportive of regulatory approvals required to market the products. Knopp undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise
PITTSBURGH--(BUSINESS WIRE)--Knopp Neurosciences Inc. ("Knopp") today announced that the European Commission ("EC") has designated KNS-760704 as an orphan medicinal product for the treatment of Amyotrophic Lateral Sclerosis.
The EC decision, based on a favorable opinion from the European Medicines Agency (EMEA), follows the designation of KNS-760704 as an orphan drug for the treatment of ALS by the U.S. Food and Drug Administration in 2007. KNS-760704 is currently in Phase 2 clinical trials for ALS, a universally fatal neurodegenerative disease with limited treatment options.
"We are very pleased with the European Commission's designation of KNS-760704 as an orphan medicinal product and the recognition of its potential to be of significant benefit for patients with ALS," said Michael Bozik, M.D., president and CEO of Knopp. "Orphan medicinal product designation will significantly facilitate our efforts to develop a safe and effective treatment for patients suffering from this relentless disease."
To stimulate the research and development of orphan drugs, the European Union ("EU") has established a centralized procedure for the designation of orphan medicinal products and provides incentives for the development of medicinal products for rare disorders. Companies with an orphan designation for a medicinal product benefit from incentives that include fee reductions, a 10-year market exclusivity period following authorization for designated products, scientific advice to optimize development, and direct access to the EMEA centralized procedures for marketing authorization.
Knopp plans to initiate Phase 3 development of KNS-760704 in ALS in late 2009.
About KNS-760704
KNS-760704 is a low molecular weight benzothiazole shown to improve mitochondrial function and confer significant cellular protection in neurons under stress. The chirally pure form of the synthetic benzothiazole (6R)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole, KNS-760704 is highly orally bioavailable, water soluble, renally excreted, and only moderately protein bound. In Phase 1 studies, the compound was shown to be safe and well tolerated in healthy human subjects. Phase 2 studies of KNS-760704 in ALS are ongoing. The compound has received orphan drug designation from the U.S. Food and Drug Administration and the European Commission for the treatment of patients with ALS.
About ALS
Amyotrophic lateral sclerosis, also known as Lou Gehrig's disease and Charcot's sclerosis, is a rapid, universally fatal neurodegenerative disorder characterized by progressive muscle weakness and wasting. ALS affects adults in the prime of life and creates a substantial burden for caregivers. U.S. prevalence is approximately 20,000 and the global incidence is approximately two per 100,000. Only one drug has been approved for the treatment of ALS. Life expectancy after symptom onset is usually three to five years.
About Knopp Neurosciences Inc.
Knopp Neurosciences is a drug discovery and development company focused on delivering breakthrough treatments for neurological disorders through innovation, experience, and partnership. The company's lead product candidate is KNS-760704, an orally bioavailable small molecule in development for the treatment of ALS. Knopp's leadership includes experienced neuroscience drug development and discovery executives formerly associated with major pharmaceutical companies. Knopp's financing has been led by Saturn Capital Inc. of Boston as placement agent and Saturn Partners II as lead funder.
This press release contains "forward-looking statements," including statements relating to Knopp's planned regulatory filings and clinical development programs for KNS-760704. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the uncertainties inherent in clinical trials and product development programs, the availability of funding to support continued research and studies, the availability or potential availability of alternative therapies or treatments, the availability of patent protection for the discoveries and strategic alliances, as well as additional factors that may cause Knopp's actual results to differ from our expectations. There can be no assurance that KNS-760704 will be successfully developed or manufactured or that final results of clinical studies will be supportive of regulatory approvals required to market the products. Knopp undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise
Tuesday, March 10, 2009
finally
FDA, Insmed, Inc. Announce Special Program for IPLEX and ALS
The U.S. Food & Drug Administration granted approval for a limited number of people with ALS in the United States to receive IPLEX, a drug that combines insulin-like growth factor (IGF-1) and IGF binding protein 3. IPLEX, which has not been approved for use in ALS, is manufactured by Richmond, VA-based Insmed, Inc. The new program is the result of an agreement between the FDA and Insmed.
The ALS Association hopes that the FDA-approved program will develop informative data about IPLEX that can lead to a better understanding of its efficacy and safety and enable both patients and clinicians to make more informed decisions about the use of IPLEX and its potential as a therapy for ALS. To this end, The Association encourages the FDA and Insmed to establish partnerships with the ALS community to ensure that the program yields meaningful results that will guide the next steps in determining whether IPLEX is effective and safe for ALS.
IPLEX originally was approved in the United States as a treatment for children with growth failure, but it is now discontinued and no longer available for this population. The drug is being tested in a now-closed study involving myotonic muscular dystrophy (MMD). Insmed is supplying IPLEX to the Italian government under an “expanded access program,” but it continues to be an untested and unproven treatment for ALS in the United States.
Based on existing clinical and scientific evidence, The ALS Association cannot encourage or recommend the off-label use of this medication without substantive evidence of its efficacy through a rigorous clinical trial. The ALS Association is continuing to monitor and assess information about IPLEX as it becomes available to provide the public with the most up-to-date reports about its potential for ALS.
Additional information on today's announcement is available here: http://www.fda.gov/cder/drug/infopage/mecasermin_rinfabate/default.htm.
For additional information from The ALS Association, please contact our Patient Services Department at alsinfo@alsa-national.org.
The U.S. Food & Drug Administration granted approval for a limited number of people with ALS in the United States to receive IPLEX, a drug that combines insulin-like growth factor (IGF-1) and IGF binding protein 3. IPLEX, which has not been approved for use in ALS, is manufactured by Richmond, VA-based Insmed, Inc. The new program is the result of an agreement between the FDA and Insmed.
The ALS Association hopes that the FDA-approved program will develop informative data about IPLEX that can lead to a better understanding of its efficacy and safety and enable both patients and clinicians to make more informed decisions about the use of IPLEX and its potential as a therapy for ALS. To this end, The Association encourages the FDA and Insmed to establish partnerships with the ALS community to ensure that the program yields meaningful results that will guide the next steps in determining whether IPLEX is effective and safe for ALS.
IPLEX originally was approved in the United States as a treatment for children with growth failure, but it is now discontinued and no longer available for this population. The drug is being tested in a now-closed study involving myotonic muscular dystrophy (MMD). Insmed is supplying IPLEX to the Italian government under an “expanded access program,” but it continues to be an untested and unproven treatment for ALS in the United States.
Based on existing clinical and scientific evidence, The ALS Association cannot encourage or recommend the off-label use of this medication without substantive evidence of its efficacy through a rigorous clinical trial. The ALS Association is continuing to monitor and assess information about IPLEX as it becomes available to provide the public with the most up-to-date reports about its potential for ALS.
Additional information on today's announcement is available here: http://www.fda.gov/cder/drug/infopage/mecasermin_rinfabate/default.htm.
For additional information from The ALS Association, please contact our Patient Services Department at alsinfo@alsa-national.org.
Monday, March 9, 2009
finally-will there be enough time.....??
Obama overturns Bush policy on stem cells
By PHILIP ELLIOTT, Associated Press Writer Philip Elliott, Associated Press Writer 26 mins ago
WASHINGTON – Reversing Bush policy, President Barack Obama on Monday cleared the way for a significant increase in federal dollars for embryonic stem cell research and promised no scientific data will be "distorted or concealed to serve a political agenda."
Obama signed the executive order on the divisive stem cell issue and a memo addressing what he called scientific integrity before an East Room audience packed with scientists. He laced his remarks with several jabs at the way science was handled by former President George W. Bush.
"Promoting science isn't just about providing resources, it is also about protecting free and open inquiry," Obama said. "It is about letting scientists like those here today do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it's inconvenient especially when it's inconvenient. It is about ensuring that scientific data is never distorted or concealed to serve a political agenda and that we make scientific decisions based on facts, not ideology."
He said his memorandum is meant to restore "scientific integrity to government decision-making." He called it the beginning of a process of ensuring his administration bases its decision on sound science; appoints scientific advisers based on their credentials, not their politics; and is honest about the science behind its decisions.
Fulfilling a campaign promise, Obama signed the order that on stem cell research that supporters believe could uncover cures for serious ailments from diabetes to paralysis. Proponents from former first lady Nancy Reagan to the late actor Christopher Reeve had pushed for ending the restrictions on research.
Obama paid tribute to Reeve, calling him a tireless advocate who was dedicated to raising awareness to the promise of research.
Obama's action reverses Bush's stem cell policy by undoing his 2001 directive that banned federal funding for research into stem lines created after Aug. 9, 2001.
The president said his administration would work aggressively to make up for the ground he said was lost due to Bush's decision, though it can't be known how much more federal money will be spent on the research until grants are applied for and issued.
"Medical miracles do not happen simply by accident," Obama declared.
Embryonic stem cells are master cells that can morph into any cell of the body. Scientists hope to harness them so they can create replacement tissues to treat a variety of diseases — such as new insulin-producing cells for diabetics, cells that could help those with Parkinson's disease or maybe even Alzheimer's, or new nerve connections to restore movement after spinal injury.
House Minority Leader John Boehner, R-Ohio, criticized Obama, saying in a statement that the president had "rolled back important protections for innocent life, further dividing our nation at a time when we need greater unity to tackle the challenges before us."
Bush limited the use of taxpayer money to only the 21 stem cell lines that had been produced before his decision. He argued he was defending human life because days-old embryos — although typically from fertility clinics and already destined for destruction — are destroyed to create the stem cell lines.
The Obama order reverses that without addressing a separate legislative ban, which precludes any federal money for the development of stem cell lines. The legislation, however, does not prevent funds for research on those lines created without federal funding.
Researchers say the newer lines created with private money during the period of the Bush ban are healthier and better suited to creating treatment for diseases.
Obama called his decision a "difficult and delicate balance," an understatement of the intense emotions generated on both sides of the long, contentious debate. He said he came down on the side of the majority of Americans who support increased federal funding for the research, both because strict oversight would prevent problems and because of the great and lifesaving potential it holds.
"Rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values," Obama said. "In this case, I believe the two are not inconsistent. As a person of faith, I believe we are called to care for each other and work to ease human suffering."
Obama warned against overstating the eventual benefits of the research, but he said his administration "will vigorously support scientists who pursue this research," taking another slap at Bush in the process.
"I cannot guarantee that we will find the treatments and cures we seek. No president can promise that. But I can promise that we will seek them actively, responsibly, and with the urgency required to make up for lost ground," he said.
It's a matter of competitive advantage globally as well, the president argued.
"When government fails to make these investments, opportunities are missed. Promising avenues go unexplored," Obama said.
But the president was insistent that his order would not open the door to human cloning.
"We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse," Obama said. "And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society."
By PHILIP ELLIOTT, Associated Press Writer Philip Elliott, Associated Press Writer 26 mins ago
WASHINGTON – Reversing Bush policy, President Barack Obama on Monday cleared the way for a significant increase in federal dollars for embryonic stem cell research and promised no scientific data will be "distorted or concealed to serve a political agenda."
Obama signed the executive order on the divisive stem cell issue and a memo addressing what he called scientific integrity before an East Room audience packed with scientists. He laced his remarks with several jabs at the way science was handled by former President George W. Bush.
"Promoting science isn't just about providing resources, it is also about protecting free and open inquiry," Obama said. "It is about letting scientists like those here today do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it's inconvenient especially when it's inconvenient. It is about ensuring that scientific data is never distorted or concealed to serve a political agenda and that we make scientific decisions based on facts, not ideology."
He said his memorandum is meant to restore "scientific integrity to government decision-making." He called it the beginning of a process of ensuring his administration bases its decision on sound science; appoints scientific advisers based on their credentials, not their politics; and is honest about the science behind its decisions.
Fulfilling a campaign promise, Obama signed the order that on stem cell research that supporters believe could uncover cures for serious ailments from diabetes to paralysis. Proponents from former first lady Nancy Reagan to the late actor Christopher Reeve had pushed for ending the restrictions on research.
Obama paid tribute to Reeve, calling him a tireless advocate who was dedicated to raising awareness to the promise of research.
Obama's action reverses Bush's stem cell policy by undoing his 2001 directive that banned federal funding for research into stem lines created after Aug. 9, 2001.
The president said his administration would work aggressively to make up for the ground he said was lost due to Bush's decision, though it can't be known how much more federal money will be spent on the research until grants are applied for and issued.
"Medical miracles do not happen simply by accident," Obama declared.
Embryonic stem cells are master cells that can morph into any cell of the body. Scientists hope to harness them so they can create replacement tissues to treat a variety of diseases — such as new insulin-producing cells for diabetics, cells that could help those with Parkinson's disease or maybe even Alzheimer's, or new nerve connections to restore movement after spinal injury.
House Minority Leader John Boehner, R-Ohio, criticized Obama, saying in a statement that the president had "rolled back important protections for innocent life, further dividing our nation at a time when we need greater unity to tackle the challenges before us."
Bush limited the use of taxpayer money to only the 21 stem cell lines that had been produced before his decision. He argued he was defending human life because days-old embryos — although typically from fertility clinics and already destined for destruction — are destroyed to create the stem cell lines.
The Obama order reverses that without addressing a separate legislative ban, which precludes any federal money for the development of stem cell lines. The legislation, however, does not prevent funds for research on those lines created without federal funding.
Researchers say the newer lines created with private money during the period of the Bush ban are healthier and better suited to creating treatment for diseases.
Obama called his decision a "difficult and delicate balance," an understatement of the intense emotions generated on both sides of the long, contentious debate. He said he came down on the side of the majority of Americans who support increased federal funding for the research, both because strict oversight would prevent problems and because of the great and lifesaving potential it holds.
"Rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values," Obama said. "In this case, I believe the two are not inconsistent. As a person of faith, I believe we are called to care for each other and work to ease human suffering."
Obama warned against overstating the eventual benefits of the research, but he said his administration "will vigorously support scientists who pursue this research," taking another slap at Bush in the process.
"I cannot guarantee that we will find the treatments and cures we seek. No president can promise that. But I can promise that we will seek them actively, responsibly, and with the urgency required to make up for lost ground," he said.
It's a matter of competitive advantage globally as well, the president argued.
"When government fails to make these investments, opportunities are missed. Promising avenues go unexplored," Obama said.
But the president was insistent that his order would not open the door to human cloning.
"We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse," Obama said. "And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society."
http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/03-09-2009/0004984875&EDATE=
Please review/double-click, the hyperlink above.
It contains some interesting stuff, to say the least.
Quick excerpt:
"This is the first demonstration of transplanted human neurons synapsing, or making mature structural connections, with the rat motor neurons, something which has not been demonstrated before," said Dr. Karl Johe, Neuralstem's Chief Scientific Officer and a study co-author. "Our earlier work with this ALS model showed that the stem cells delayed onset of the disease and played a neuroprotective role. Now we have clear evidence that they can become an integral part of the rat nervous system that controls the muscles. I would expect these cells to be readily accepted by and integrated into a human nervous system, such as in an ALS or a spinal cord injury patient."
iplex info
To:
teamiplex@googlegroups.com
Randy and Bob,
I believe you both saw this on ALSTDI forum, where I posted it March 2. Nothing has changed. The FDA will do what they’re going to do—with or without Italian data. This is no longer an issue of science (data about whether Iplex is or is not pre-proven and good for those with ALS). It’s simply an issue of whether or not they can deny a terminal population a medication that is already FDA approved—nothing else. That’s an issue of state statutes, federal law and FDA practice—all of which they (FDA) are now violating. And those physicians who will write off-label Rx’s or INDs will do so with or without Italian data—which they find suspect under the best of situations. And those who won’t write off-label or INDs will not start doing so because they see data from an Italian “observation.”
Anyone reading this can use their time more constructively by writing to your legislators and to FDA, using as a template that which you have previously seen from several people—me, Eddie Esparza and others. Or, write a new and different message demanding the right to use Iplex.
Regards,
Steve Byer
From ALSTDI FORUM March 2, 2009
Dear Randy,When reading the following, please bear in mind that I am neither an apologist nor spokesperson for Insmed. Because of my interest in Iplex as a potential treatment for ALS, I have been able to make some communication inroads with Insmed and others related to this issue. I think, from your post quoted just below, and others from you more recently, it is advisable to share some thoughts on the subject.“I feel like a broken record and apologies if this has been covered in another post, but it has now been almost 3 months since the Iplex rally, at which time we were told (those of us who attended) that the Italian data would be released soon. I understood that it was this data that was to be the predicate of further activities and pursuits of obtaining it in the U.S. and maybe elsewhere. Have I missed something? Has this data been released or, if not, any indication as to when this will happen? I suppose "soon" could be anytime, but with each passing day an no news on this front, it looks more and more like either there was misinformation, miscommunication or attempts by one or more parties to mislead and spread false hope. I hope I'm wrong about this, of course.” Questioner ALS-TDI forum 02/09/09In response to the above and other of your posts and emails:1. When I asked for the data on December 22, Insmed stated they have turned over the results to two separate researchers for analysis and comparison to historical placebos. They had, just then, received the data from Italy after “numerous requests.”2. When I asked again on January 19, 2009, they stated both companies were having difficulty analyzing the information received from Italy because of the difficult nature of translating data from many different areas of Italy (20), many different age and progression groups, many different analyses by physicians treating the patients (I think it was 20 physicians) and few patients in the study (only 60 because they excluded all others who weren’t on Iplex for at least a certain time period). In other words, it was never purported to be a clinical test study—but rather “an observation.”3. While the information is unsatisfactory to me, and perhaps to you, it’s also understandable even by those of us who would prefer a clear set of study data and results from a well-conducted double-blind test study.4. Those with ALS don’t always have the luxury of time that a clinical test study requires. In the case of Myotrophin, an inferior drug for the purpose of treating ALS, it took from 1997 to 2009 for the results to be finalized. Even then, the results were unclear and marred by ineffective dosages and contradictory results from three different trials (in US, EU and again US).5. Therefore, those with diseases such as ALS (little-understood, no apparent cure, almost always treated unsuccessfully) are sometimes required to try a medication even without the benefit of prior test data if there is some, or any, reason to feel the treatment has promise. In the case of Iplex, there are several foundations, or at least suggestions, to feel the drug has promise. 6. You already know what those are, but just in case: prior usage by eight US patients in early 2007; continuing usage by now of up to 180 Italian patients paid for by the Italian government (a cost I doubt they take lightly); the results thus far of use by those with Myotonic muscular dystrophy (University of Rochester—a continuing study); scientific foundations previously provided you and others regarding the underlying benefits of IGF-1/IGFbp-3 vs free IGF-1; hope for Iplex when other hope doesn’t exist.7. Insmed has nonetheless stated that, from the little information on hand, there appears to have been a positive effect from at least 50% of those who were in the 60-patient group. That is my recollection of the specific words, and while it may be ever-so-slightly off, the meaning was clear—50% of those with ALS treated with anything is a success. I didn’t think to ask, at the time, if the remaining 50% were “stable, declining, or otherwise.”8. I was asked, at the time of the conversations above, not to publicize the information because it was unconfirmed and to some extent conjecture. Further, Insmed, as a public company, is unable to release such information without qualification because it can be construed as “forward-looking statements”, a legal issue for public companies. I do feel that enough time has passed from the conversations that it can be disseminated.9. If this is, in anyone’s view, “misinformation, miscommunication or attempts by one or more parties to mislead and spread false hope”, then so be it. Steve Byer
teamiplex@googlegroups.com
Randy and Bob,
I believe you both saw this on ALSTDI forum, where I posted it March 2. Nothing has changed. The FDA will do what they’re going to do—with or without Italian data. This is no longer an issue of science (data about whether Iplex is or is not pre-proven and good for those with ALS). It’s simply an issue of whether or not they can deny a terminal population a medication that is already FDA approved—nothing else. That’s an issue of state statutes, federal law and FDA practice—all of which they (FDA) are now violating. And those physicians who will write off-label Rx’s or INDs will do so with or without Italian data—which they find suspect under the best of situations. And those who won’t write off-label or INDs will not start doing so because they see data from an Italian “observation.”
Anyone reading this can use their time more constructively by writing to your legislators and to FDA, using as a template that which you have previously seen from several people—me, Eddie Esparza and others. Or, write a new and different message demanding the right to use Iplex.
Regards,
Steve Byer
From ALSTDI FORUM March 2, 2009
Dear Randy,When reading the following, please bear in mind that I am neither an apologist nor spokesperson for Insmed. Because of my interest in Iplex as a potential treatment for ALS, I have been able to make some communication inroads with Insmed and others related to this issue. I think, from your post quoted just below, and others from you more recently, it is advisable to share some thoughts on the subject.“I feel like a broken record and apologies if this has been covered in another post, but it has now been almost 3 months since the Iplex rally, at which time we were told (those of us who attended) that the Italian data would be released soon. I understood that it was this data that was to be the predicate of further activities and pursuits of obtaining it in the U.S. and maybe elsewhere. Have I missed something? Has this data been released or, if not, any indication as to when this will happen? I suppose "soon" could be anytime, but with each passing day an no news on this front, it looks more and more like either there was misinformation, miscommunication or attempts by one or more parties to mislead and spread false hope. I hope I'm wrong about this, of course.” Questioner ALS-TDI forum 02/09/09In response to the above and other of your posts and emails:1. When I asked for the data on December 22, Insmed stated they have turned over the results to two separate researchers for analysis and comparison to historical placebos. They had, just then, received the data from Italy after “numerous requests.”2. When I asked again on January 19, 2009, they stated both companies were having difficulty analyzing the information received from Italy because of the difficult nature of translating data from many different areas of Italy (20), many different age and progression groups, many different analyses by physicians treating the patients (I think it was 20 physicians) and few patients in the study (only 60 because they excluded all others who weren’t on Iplex for at least a certain time period). In other words, it was never purported to be a clinical test study—but rather “an observation.”3. While the information is unsatisfactory to me, and perhaps to you, it’s also understandable even by those of us who would prefer a clear set of study data and results from a well-conducted double-blind test study.4. Those with ALS don’t always have the luxury of time that a clinical test study requires. In the case of Myotrophin, an inferior drug for the purpose of treating ALS, it took from 1997 to 2009 for the results to be finalized. Even then, the results were unclear and marred by ineffective dosages and contradictory results from three different trials (in US, EU and again US).5. Therefore, those with diseases such as ALS (little-understood, no apparent cure, almost always treated unsuccessfully) are sometimes required to try a medication even without the benefit of prior test data if there is some, or any, reason to feel the treatment has promise. In the case of Iplex, there are several foundations, or at least suggestions, to feel the drug has promise. 6. You already know what those are, but just in case: prior usage by eight US patients in early 2007; continuing usage by now of up to 180 Italian patients paid for by the Italian government (a cost I doubt they take lightly); the results thus far of use by those with Myotonic muscular dystrophy (University of Rochester—a continuing study); scientific foundations previously provided you and others regarding the underlying benefits of IGF-1/IGFbp-3 vs free IGF-1; hope for Iplex when other hope doesn’t exist.7. Insmed has nonetheless stated that, from the little information on hand, there appears to have been a positive effect from at least 50% of those who were in the 60-patient group. That is my recollection of the specific words, and while it may be ever-so-slightly off, the meaning was clear—50% of those with ALS treated with anything is a success. I didn’t think to ask, at the time, if the remaining 50% were “stable, declining, or otherwise.”8. I was asked, at the time of the conversations above, not to publicize the information because it was unconfirmed and to some extent conjecture. Further, Insmed, as a public company, is unable to release such information without qualification because it can be construed as “forward-looking statements”, a legal issue for public companies. I do feel that enough time has passed from the conversations that it can be disseminated.9. If this is, in anyone’s view, “misinformation, miscommunication or attempts by one or more parties to mislead and spread false hope”, then so be it. Steve Byer
Sunday, March 8, 2009
Stem cells can help regrow diseased muscles
Stem cells can help regrow diseased muscles
Sydney, March 6 : An experimental procedure that dramatically strengthens stem cells' ability to regenerate damaged tissue could offer new hope to victims of muscle-wasting diseases like myopathy and muscular dystrophy.
The first-ever procedure has been successfully used to regrow muscles in a mouse model, but it could be applied to all tissue-based illnesses in humans in the liver, pancreas or brain, the researchers say. The research team, which is based at University of New South Wales (UNSW) and formerly from Sydney 's Westmead Children's Hospital, adapted a technique currently being tried in bone marrow transplantation. Adult stem cells are given a gene that makes them resistant to chemotherapy, which is used to clean out damaged cells and allow the new stem cells to take hold. The ability of adult stem cells to regenerate whole tissues opens up a world of new possibilities for many diseases, according to the study co-authors, Peter Gunning and Edna Hardeman, both professors, and Antonio Lee, from UNSW's School of Medical Sciences. "What has been the realm of science fiction is looking more and more like the medicine of the future," Gunning said. The procedure solves one of the major hurdles involving stem cell therapy - getting the cells to survive for more than an hour or so after inserting them into damaged tissue, said an UNSW release. These findings were detailed in the journal Stem Cells.
Sydney, March 6 : An experimental procedure that dramatically strengthens stem cells' ability to regenerate damaged tissue could offer new hope to victims of muscle-wasting diseases like myopathy and muscular dystrophy.
The first-ever procedure has been successfully used to regrow muscles in a mouse model, but it could be applied to all tissue-based illnesses in humans in the liver, pancreas or brain, the researchers say. The research team, which is based at University of New South Wales (UNSW) and formerly from Sydney 's Westmead Children's Hospital, adapted a technique currently being tried in bone marrow transplantation. Adult stem cells are given a gene that makes them resistant to chemotherapy, which is used to clean out damaged cells and allow the new stem cells to take hold. The ability of adult stem cells to regenerate whole tissues opens up a world of new possibilities for many diseases, according to the study co-authors, Peter Gunning and Edna Hardeman, both professors, and Antonio Lee, from UNSW's School of Medical Sciences. "What has been the realm of science fiction is looking more and more like the medicine of the future," Gunning said. The procedure solves one of the major hurdles involving stem cell therapy - getting the cells to survive for more than an hour or so after inserting them into damaged tissue, said an UNSW release. These findings were detailed in the journal Stem Cells.
How stem cells turn into blood cells
How stem cells turn into blood cells
Washington, Mar 6 : A research team led by an Indian origin scientist has shed light on how stem cells turn into blood cells.
Stem cells are the building blocks of every organ and tissue in the body. They have a unique ability to become any type of cell in the body including bone, muscle and blood cells.Dr. Mick Bhatia, director of the McMaster University Stem Cell and Cancer Research Institute claim to have identified a particular cell pathway, known as the noncanonical Wnt that prompts stem cells to specialize and become blood cells.The pathway appears to organize the stem cells so that they can respond to signals telling them what to turn into."By directing cell differentiation, this method provides the most efficient way to produce blood cells that we are aware of to date," said Bhatia."This finding is exciting because it may provide a new way to make blood from human stem cells that could be used to regenerate the blood system in patients, including those with leukemia or those undergoing cancer treatments
that indirectly destroy the immune and blood system," said Dr. Christine Williams, Director of Research Programs at the Canadian Cancer Society Research Institute.The findings are published in Cell Stem Cell.
Washington, Mar 6 : A research team led by an Indian origin scientist has shed light on how stem cells turn into blood cells.
Stem cells are the building blocks of every organ and tissue in the body. They have a unique ability to become any type of cell in the body including bone, muscle and blood cells.Dr. Mick Bhatia, director of the McMaster University Stem Cell and Cancer Research Institute claim to have identified a particular cell pathway, known as the noncanonical Wnt that prompts stem cells to specialize and become blood cells.The pathway appears to organize the stem cells so that they can respond to signals telling them what to turn into."By directing cell differentiation, this method provides the most efficient way to produce blood cells that we are aware of to date," said Bhatia."This finding is exciting because it may provide a new way to make blood from human stem cells that could be used to regenerate the blood system in patients, including those with leukemia or those undergoing cancer treatments
that indirectly destroy the immune and blood system," said Dr. Christine Williams, Director of Research Programs at the Canadian Cancer Society Research Institute.The findings are published in Cell Stem Cell.
Friday, March 6, 2009
my cousin sent me this, thanks sally
Source: Obama to reverse limits on stem cell work
By BEN FELLER and LAURAN NEERGAARD, Associated Press Writers Ben Feller And Lauran Neergaard, Associated Press Writers 1 min ago
WASHINGTON – President Barack Obama expected to sign an executive order on Monday reversing restrictions on federal funding of embryonic stem cell research.
The long-expected move is likely to stir up not only the promise of scientific breakthrough but also the controversy over where government crosses a moral line.
Obama will hold an event at the White House to announce the move, a senior administration official said Friday. The official spoke on condition of anonymity because the policy had not yet been publicly announced.
Under President George W. Bush, federal money for research on human embryonic stems cells was limited to those stem cell lines that were created before Aug. 9, 2001. No federal dollars could be used on research with cell lines from embryos destroyed from that point forward.
Obama's move is expected to lift that restriction. The official said the aim of the policy is restore "scientific integrity" to the process.
Embryonic stem cells are master cells that can morph into any cell of the body. Scientists hope to harness them so they can create replacement tissues to treat a variety of diseases — such as new insulin-producing cells for diabetics or new nerve connections to restore movement after spinal injury.
"I feel vindicated after eight years of struggle, and I know it's going to energize my research team," said Dr. George Daley of the Harvard Stem Cell Institute and Children's Hospital of Boston, a leading stem cell researcher.
Such research is controversial because embryos must be destroyed to obtain the cells; they typically are culled from fertility-clinic leftovers otherwise destined to be thrown away. Once a group of stem cells is culled, it can be kept alive and propagating in lab dishes for years.
There are different types of stem cells, and critics say the nation should pursue alternatives to embryonic ones such as adult stem cells, or those found floating in amniotic fluid or the placenta. But leading researchers consider embryonic stem cells the most flexible, and thus most promising, form — and say that science, not politics, should ultimately judge.
"Science works best and patients are served best by having all the tools at our disposal," Daley said.
Obama made it clear during the campaign he would overturn Bush's directive.
During the campaign, Obama said, "I strongly support expanding research on stem cells. I believe that the restrictions that President Bush has placed on funding of human embryonic stem cell research have handcuffed our scientists and hindered our ability to compete with other nations."
He said he would lift Bush's ban and "ensure that all research on stem cells is conducted ethically and with rigorous oversight."
"Patients and people who've been patient advocates are going to be really happy," said Amy Comstock Rick of the Coalition for the Advancement of Medical Research.
The ruling will bring one immediate change: As of Monday, scientists who've had to meticulously keep separate their federally funded research and their privately funded stem cell work — from buying separate microscopes to even setting up labs in different buildings — won't have that expensive hurdle anymore.
Next, scientists can start applying for research grants from the National Institutes of Health. The NIH already has begun writing guidelines for what embryonic stem cell lines will qualify under Obama's ruling. Among other things, the guidelines are expected to demand that the cells were derived with proper informed consent from the woman or couple who donated the original embryo.
By BEN FELLER and LAURAN NEERGAARD, Associated Press Writers Ben Feller And Lauran Neergaard, Associated Press Writers 1 min ago
WASHINGTON – President Barack Obama expected to sign an executive order on Monday reversing restrictions on federal funding of embryonic stem cell research.
The long-expected move is likely to stir up not only the promise of scientific breakthrough but also the controversy over where government crosses a moral line.
Obama will hold an event at the White House to announce the move, a senior administration official said Friday. The official spoke on condition of anonymity because the policy had not yet been publicly announced.
Under President George W. Bush, federal money for research on human embryonic stems cells was limited to those stem cell lines that were created before Aug. 9, 2001. No federal dollars could be used on research with cell lines from embryos destroyed from that point forward.
Obama's move is expected to lift that restriction. The official said the aim of the policy is restore "scientific integrity" to the process.
Embryonic stem cells are master cells that can morph into any cell of the body. Scientists hope to harness them so they can create replacement tissues to treat a variety of diseases — such as new insulin-producing cells for diabetics or new nerve connections to restore movement after spinal injury.
"I feel vindicated after eight years of struggle, and I know it's going to energize my research team," said Dr. George Daley of the Harvard Stem Cell Institute and Children's Hospital of Boston, a leading stem cell researcher.
Such research is controversial because embryos must be destroyed to obtain the cells; they typically are culled from fertility-clinic leftovers otherwise destined to be thrown away. Once a group of stem cells is culled, it can be kept alive and propagating in lab dishes for years.
There are different types of stem cells, and critics say the nation should pursue alternatives to embryonic ones such as adult stem cells, or those found floating in amniotic fluid or the placenta. But leading researchers consider embryonic stem cells the most flexible, and thus most promising, form — and say that science, not politics, should ultimately judge.
"Science works best and patients are served best by having all the tools at our disposal," Daley said.
Obama made it clear during the campaign he would overturn Bush's directive.
During the campaign, Obama said, "I strongly support expanding research on stem cells. I believe that the restrictions that President Bush has placed on funding of human embryonic stem cell research have handcuffed our scientists and hindered our ability to compete with other nations."
He said he would lift Bush's ban and "ensure that all research on stem cells is conducted ethically and with rigorous oversight."
"Patients and people who've been patient advocates are going to be really happy," said Amy Comstock Rick of the Coalition for the Advancement of Medical Research.
The ruling will bring one immediate change: As of Monday, scientists who've had to meticulously keep separate their federally funded research and their privately funded stem cell work — from buying separate microscopes to even setting up labs in different buildings — won't have that expensive hurdle anymore.
Next, scientists can start applying for research grants from the National Institutes of Health. The NIH already has begun writing guidelines for what embryonic stem cell lines will qualify under Obama's ruling. Among other things, the guidelines are expected to demand that the cells were derived with proper informed consent from the woman or couple who donated the original embryo.
Wednesday, March 4, 2009
http://www.google.com/search?sourceid=navclient&aq=h0&oq=&ie=UTF-8&rlz=1T4GGLL_enUS302US302&q=Italians+find+ALS+gene The 1.5-million-euro study, which
http://www.google.com/search?sourceid=navclient&aq=h0&oq=&ie=UTF-8&rlz=1T4GGLL_enUS302US302&q=Italians+find+ALS+gene
The 1.5-million-euro study, which looked at the so-called 'sporadic' type of ALS, identified a gene called Sunc1 which appears to play a predominant role in regulating ALS. But Chio' said Sunc1 was "probably just the tip of the iceberg." He said the study will now move into a third phase in which 300 new patients will be examined, all of them Italian.
The 1.5-million-euro study, which looked at the so-called 'sporadic' type of ALS, identified a gene called Sunc1 which appears to play a predominant role in regulating ALS. But Chio' said Sunc1 was "probably just the tip of the iceberg." He said the study will now move into a third phase in which 300 new patients will be examined, all of them Italian.
epidermal growth factor
Epidermal growth factor promotes the differentiation of stem cells derived from human umbilical cord blood into neuron-like cells via taurine induction in vitro.
Jin W, Xing YQ, Yang AH.Department of Ophthalmology, Renmin Hospital of Wuhan University, Jiefang Road 238#, Wuhan, Hubei Province, 430060,
People's Republic of China.Results of recent investigations have demonstrated the plasticity of mesenchymal stem cells (MSC) can differentiate into neural lineages. In this study, we explored the experimental condition of differentiation into neuron-like cells or rhodopsin (RHOS)-positive cells induced by epidermal growth factor (EGF) and taurine in vitro and to investigate their biological characteristics. MSC were obtained from umbilical cord blood (UCB) of term deliveries. Cultured cells were treated with Dulbecco's modified Eagle's medium/F12 (pH 7.0-7.2) supplemented with 30 ng/ml EGF. After the third cell passage, the cells were trysinized and analyzed with a flow cytometer using the following monocloned antibodies: CD90, CD29, CD34, CD44, and CD45. Taking another MSC of the third passage, its basal medium was replaced with alpha minimum essential medium supplemented with taurine (50 micromol/L). Cells were cultured for an additional 8-10 d, fixed, and then immunocytochemicall y analyzed. Primary antibodies included the following: neuron-specific enolase (NSE), RHOS, and nestin. In our study, we isolated a cell population derived from UCB, which possesses morphological characteristics similar to those of MSC isolated from bone marrow. In the cytometric analysis, MSC did not present labeling for the hematopoietic line (CD34 and CD45) and were positive for CD29, CD44, and CD90. After induction by taurine, 80.5 +/- 16.2% of the cell population expressed NSE, 36.8 +/- 9.6% expressed RHOS, and 29.6 +/- 9.3% expressed Nestin, while only 7.9 +/- 3.5% expressed NSE in the control group. This study demonstrates that partial MSC induced by taurine and EGF can differentiate into neuron-like cells or RHOS-positive cells in vitro, which may provide a promising therapeutic strategy for the treatment of some forms of retinal degeneration.
Monday, March 2, 2009
Stem cell breakthrough now goes one step further
Sun Mar 1, 1:20 pm ET
PARIS (AFP) – Pioneering work by Japanese stem-cell researchers two years ago has taken a major step forward, helping the quest for versatile, grow-in-a-dish transplant tissue, according to papers published on Sunday.
Two teams have combined ideas to devise a safer technique for reprogramming skin cells so that they become "pluripotent" stem cells -- fundamental cells that then grow into specialised organs.
Their effort builds on an award-winning breakthrough in 2007 by Shinya Yamanaka of Kyoto University.
He and his team introduced four genes into skin cells, reprogramming them so that they became indistinguishable from embryonic stem cells.
That achievement conjured the distant vision of an almost limitless source of transplant material that would be free of controversy, as it would entail no cells derived from embryos.
But the downside of the technique for creating these so-called induced pluripotent stem cells (iPS) is that the genes are delivered by a "Trojan horse" virus.
Reprogramming cells using a virus modifies their DNA in such a way that they cannot be given to patients without boosting the risk of cancer.
In the new studies, published by the British-based journal Nature, two squads of researchers from Britain and Canada recount a method by which the four genes are delivered into the cell without using a virus -- and then are removed after the reprogramming is done.
The insertion is carried out using "piggyBac," a tried-and-tested technique in genetically-modified crops in which mobile genetic sequences called transposons are slotted into the genome.
In the iPS work, it has been tested successfully on mouse and human skin cells. Tests on the reprogrammed cells lines show they faithfully reproduce the behaviour of embryonic stem cells.
"I was very excited when I found stem cell-like cells in my culture dishes. Nobody, including me, thought it was really possible," said Keisuke Kaji from the Centre for Regenerative Medicine at the University of Edinburgh, Scotland.
In a press release issued by Britain's Medical Research Council, Ian Wilmut -- the "father" of Dolly the cloned sheep -- stressed that the new iPS cells would have to be tested thoroughly for safety before being used in any human trials.
And, "crucially," scientists were still hunting for a way of coaxing pluripotent cells into the specialised tissues that could be used in transplants, said Wilmut, who heads the unit where Kaji works.
Even so, "there is hope that the promise of regenerative medicine could soon be met," he said.
Stem cells have excited huge interest over the past decade. Promoters say this material could reverse cancer, diabetes, Alzheimer's and other regenerative diseases.
But the dynamic has been sapped by opposition from religious conservatives, who argue that research on embryos -- the prime source of stem cells so far -- destroys human life.
Sun Mar 1, 1:20 pm ET
PARIS (AFP) – Pioneering work by Japanese stem-cell researchers two years ago has taken a major step forward, helping the quest for versatile, grow-in-a-dish transplant tissue, according to papers published on Sunday.
Two teams have combined ideas to devise a safer technique for reprogramming skin cells so that they become "pluripotent" stem cells -- fundamental cells that then grow into specialised organs.
Their effort builds on an award-winning breakthrough in 2007 by Shinya Yamanaka of Kyoto University.
He and his team introduced four genes into skin cells, reprogramming them so that they became indistinguishable from embryonic stem cells.
That achievement conjured the distant vision of an almost limitless source of transplant material that would be free of controversy, as it would entail no cells derived from embryos.
But the downside of the technique for creating these so-called induced pluripotent stem cells (iPS) is that the genes are delivered by a "Trojan horse" virus.
Reprogramming cells using a virus modifies their DNA in such a way that they cannot be given to patients without boosting the risk of cancer.
In the new studies, published by the British-based journal Nature, two squads of researchers from Britain and Canada recount a method by which the four genes are delivered into the cell without using a virus -- and then are removed after the reprogramming is done.
The insertion is carried out using "piggyBac," a tried-and-tested technique in genetically-modified crops in which mobile genetic sequences called transposons are slotted into the genome.
In the iPS work, it has been tested successfully on mouse and human skin cells. Tests on the reprogrammed cells lines show they faithfully reproduce the behaviour of embryonic stem cells.
"I was very excited when I found stem cell-like cells in my culture dishes. Nobody, including me, thought it was really possible," said Keisuke Kaji from the Centre for Regenerative Medicine at the University of Edinburgh, Scotland.
In a press release issued by Britain's Medical Research Council, Ian Wilmut -- the "father" of Dolly the cloned sheep -- stressed that the new iPS cells would have to be tested thoroughly for safety before being used in any human trials.
And, "crucially," scientists were still hunting for a way of coaxing pluripotent cells into the specialised tissues that could be used in transplants, said Wilmut, who heads the unit where Kaji works.
Even so, "there is hope that the promise of regenerative medicine could soon be met," he said.
Stem cells have excited huge interest over the past decade. Promoters say this material could reverse cancer, diabetes, Alzheimer's and other regenerative diseases.
But the dynamic has been sapped by opposition from religious conservatives, who argue that research on embryos -- the prime source of stem cells so far -- destroys human life.
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