<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20090101_19_673"
                     title="Stem Cell Research Takes Another Step Forward"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/tb/13133?impressionId=1265781938742"
                     
      CAMBRIDGE, Mass., March 5 -- For the second time in a week, researchers are reporting a novel way to make human stem cells from skin without the risk of disease caused by genetic manipulation.
              &lt;p&gt; 
              &lt;p&gt;Using skin fibroblasts from people with Parkinson&apos;s disease, Rudolf Jaenisch, M.D., of the Whitehead Institute and colleagues used now-established methods to create what are called induced pluripotent stem cells.
              &lt;p&gt; 
              &lt;p&gt;The new wrinkle, they reported in the March 6 issue of &lt;em&gt;Cell&lt;/em&gt;, is that they were then able to remove all traces of the factors used to reprogram the skin cells.
              &lt;p&gt; 
              &lt;p&gt;The report comes only days after two collaborating groups -- one in Great Britain and one in Canada -- reported on a way to generate such cells without using viruses to insert the reprogramming factors. (See: &lt;a href=&quot;http://www.medpagetoday.com/Genetics/GeneralGenetics/13099&quot; target=&quot;blank&quot;&gt;Two Teams &apos;PiggyBAC&apos; Stem Cell Research&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;Skin cells can be a fertile source of pluripotent cells, as several research groups have shown. But the method -- using a virus to carry four genes into skin cells -- is thought to carry the risk of disease. (See: &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/7443&quot; target=&quot;blank&quot;&gt;Adult Skin Cells Reprogrammed into Stem Cells for Disease Research&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;The four genes -- &lt;em&gt;c-Myc&lt;/em&gt;, &lt;em&gt;Klf4&lt;/em&gt;, &lt;em&gt;Oct4&lt;/em&gt; and &lt;em&gt;Sox&lt;/em&gt; -- reprogram skin cells to act as stem cells, but the virus itself is considered a potential danger, since it could disrupt the DNA of a patient&apos;s cell and possibly cause cancer. In addition, &lt;em&gt;c-Myc&lt;/em&gt; is an oncogene and some of the other genes involved can also cause cancer.
              &lt;p&gt; 
              &lt;p&gt;There are also concerns that the viral vector may affect what genes are on or off in the newly created stem cells, so that the use of viruses is a major limitation of current technology, Dr. Jaenisch said in a statement.
              &lt;p&gt; 
              &lt;p&gt;To get around that limit, he said, &quot;we used a modified virus you can excise. After they&apos;ve done their job, you can get rid of them.&quot;
              &lt;p&gt; 
              &lt;p&gt;The researchers took skin fibroblasts from five patients with idiopathic Parkinson&apos;s disease and two healthy volunteers. Using either all four of the reprogramming factors or a subset lacking &lt;em&gt;c-Myc&lt;/em&gt;, they employed a lentivirus to carry the genes into the cells.
              &lt;p&gt; 
              &lt;p&gt;The trick was that the lentivirus had been modified so that it could be found and excised by an enzyme called Cre recombinase. 
              &lt;p&gt; 
              &lt;p&gt;After a line of stem cells had been created, they could be treated with the enzyme to establish a daughter line that retained no trace of the original reprogramming factors or the viral vector, the researchers said.
              &lt;p&gt; 
              &lt;p&gt;Both sets of cell lines -- with and without the reprogramming factors -- were shown to have the genetic markers of pluripotency and could be made to grow into dopaminergic neurons, Dr. Jaenisch and colleagues said.
              &lt;p&gt; 
              &lt;p&gt;The establishment of in vitro lines of neurons derived from Parkinson&apos;s patients should be a boon to research on the disease, Dr. Jaenisch and colleagues said.
              &lt;p&gt; 
              &lt;p&gt;&quot;Such in vitro models could be utilized for large-scale genetic or drug-based screens since large numbers of (stem cells) can be generated and robustly differentiated into dopaminergic neurons,&quot; they said. 
              &lt;p&gt; 
              &lt;p&gt;But the new method of getting rid of the transforming factors is also important, since one aspect of the experiments showed that they affect the genetic profile of the new stem cell.
              &lt;p&gt; 
              &lt;p&gt;Dr. Jaenisch and colleagues used genome-wide expression analysis to see what genes were active in human embryonic stem cells, induced pluripotent stem cells, and the induced stem cells without the transforming factors.
              &lt;p&gt; 
              &lt;p&gt;They found 271 genes whose expression was significantly different (at &lt;em&gt;P&lt;/em&gt;&lt;0.05) in embryonic stem cells, compared with induced pluripotent cells. 
              &lt;p&gt; 
              &lt;p&gt;In contrast, they found, only 48 genes were differentially expressed between embryonic stem cells and the factor-free pluripotent cells -- a reduction of 80%.
              &lt;p&gt; 
              &lt;p&gt;&quot;The vector-free cells are much more closely related to embryonic stem cells than to the parental cells,&quot; Dr. Jaenisch said. The finding &quot;argues that even low vector expression somehow changes the transcriptional profile of cells.&quot;
              &lt;p&gt; 
              &lt;p&gt;The factor-free stem cells may also form a source of neurons for transplant, the researchers said, especially since they were derived from patients regardless of age.
              &lt;p&gt; 
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;The research was supported by the Life Science Research Foundation, the National Institutes of Health, the Howard Hughes Medical Institute, Udall Parkinson&apos;s Disease Center of Excellence, and the Michael Stern Foundation.
              &lt;p&gt;Dr. Jaenisch is an adviser to Stemgent, which has obtained a license from MIT to distribute some of the reagents used in this paper. &lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
         
    </recommendedItem>
    <recommendedItem id="20090101_19_699"
                     title="Obama Lifts Embryonic Stem Cell Restrictions"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/tb/13170?impressionId=1265781938742"
                     
      WASHINGTON, March 9 -- There are two kinds of cell-sorters in David Scadden&apos;s lab at the Harvard Stem Cell Institute -- machines that have green tags and machines that don&apos;t.
              &lt;p&gt; 
              &lt;p&gt;The devices, which cost $500,000 and up, do exactly the same thing. The only difference: if your research is funded by the taxpayers, you can&apos;t use a green-tagged machine.
              &lt;p&gt; 
              &lt;p&gt;President Barack Obama lifted his predecessor&apos;s restrictions on human embryonic stem cell research today, and in doing so, put an end to bizarre rules like this one at Dr. Scadden&apos;s lab and others around the country.
              &lt;p&gt; 
              &lt;p&gt;The color-coded system ensured that federally-funded scientists didn&apos;t accidentally violate former President George W. Bush&apos;s 2001 executive order limiting embryonic stem cell research to lines created before Aug. 9 of that year.
              &lt;p&gt; 
              &lt;p&gt;But the rule was more than an annoyance: it meant that labs had to spend millions on duplicate equipment. Worse yet, according to Dr. Scadden, it prohibited collaboration and hindered the advancement of science.
              &lt;p&gt; 
              &lt;p&gt;So the Harvard researcher says the green tags will go, and scientists nationwide will now have access to billions in funding for embryonic stem cell research with far fewer restrictions.
              &lt;p&gt; 
              &lt;p&gt;In a larger sense, the rules were also symbols of the power of religious and political conservatives within the Bush administration. Obama is changing many of these rules --  with a pledge to keep politics out of science.
              &lt;p&gt; 
              &lt;p&gt;Along with his executive order, Obama issued a memorandum to guide development of a White House strategy for &quot;restoring scientific integrity to government decision-making.&quot;
              &lt;p&gt;
              &lt;p&gt;He said science &quot;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.&quot;
              &lt;p&gt;
              &lt;p&gt;&lt;strong&gt;New Stem Cell Lines are Needed, Scientists Say&lt;/strong&gt;
              &lt;p&gt; 
              &lt;p&gt;When the Bush administration&apos;s rules were established 2001, some scientists thought that as many as 60 embryonic stem cell lines might qualify for continued federal research funding.
              &lt;p&gt; 
              &lt;p&gt;But only 21 proved viable over the long term, and they&apos;re no longer up to speed with scientists, researchers said.
              &lt;p&gt; 
              &lt;p&gt;&quot;The old lines are of decreasing usefulness in the laboratory and they&apos;re not very diverse,&quot; said Jonathan Moreno, Ph.D., a medical ethicist at the University of Pennsylvania and a senior fellow at the Center for American Progress in Washington. 
              &lt;p&gt; 
              &lt;p&gt;In addition, the old lines were originally grown on mice cells. That has the potential to introduce foreign agents into the human embryonic cells, and thus into any humans treated clinically with cells developed from them, said Jim Battey, M.D., Ph.D., vice chair of the NIH Stem Cell Task Force. 
              &lt;p&gt; 
              &lt;p&gt;Scientists now know how to grow human stem cell lines without the animal-cell support, but the original lines remain potentially contaminated. 
              &lt;p&gt; 
              &lt;p&gt;Critics of embryonic stem cells for research say other types of stem cells -- derived from umbilical cord blood, adult skin cells, or other sources -- can produce the same result without destroying a potential human life. 
              &lt;p&gt; 
              &lt;p&gt;They point to recent advances made with induced pluripotent stem cells as proof that embryos don&apos;t need to be destroyed to further research. 
              &lt;p&gt; 
              &lt;p&gt;Last week, several groups of scientists reported developing human stem cells from adult skin without the risk of disease associated with viral vectors used in the transformation. (See: &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/13133&quot; target=&quot;blank&quot;&gt;Stem Cell Research Takes Another Step Forward&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/13099&quot; target=&quot;blank&quot;&gt;Two Teams &apos;PiggyBAC&apos; Stem Cell Research&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;But despite the new advances, embryonic stem cells are the purest and earliest form of a stem cell, and the &quot;gold standard,&quot; said Valina Dawson, Ph.D., co-director of the neuroregeneration program in the Institute for Cell Engineering at Johns Hopkins. 
              &lt;p&gt; 
              &lt;p&gt;&quot;Theoretically, it&apos;s like Play-Doh and you can make whatever you want,&quot; said Dr. Dawson.
              &lt;p&gt; 
              &lt;p&gt;Douglas Melton, Ph.D., co-director of HSCI -- a leader in developing induced pluripotent stem cells from adult cells -- announced plans to seek federal funding for embryonic stem cell research as soon as the Bush order is lifted.
              &lt;p&gt; 
              &lt;p&gt;Researchers like Drs. Dawson and Melton hope the embryonic stem cells hold the key to curing neurological disorders such as Parkinson&apos;s and stroke. 
              &lt;p&gt; 
              &lt;p&gt;While Bush&apos;s order has been a barrier for federally-funded scientists, private companies have created new embryonic stem cell lines. But few investors are willing to gamble on a therapy so far away from being ready human patients. 
              &lt;p&gt; 
              &lt;p&gt;&quot;I&apos;m in the private sector and right now, we&apos;re not getting paychecks. It&apos;s pretty tough,&quot; said Robert Lanza, M.D., chief scientific officer at Advanced Cell Technology, a biotech company in Massachusetts working with stem cell technology. 
              &lt;p&gt; 
              &lt;p&gt;According to the Coalition for the Advancement of Medical Research (CAMR) privately-funded scientists are &quot;eager to share cell lines with researchers to speed discoveries&quot; but cannot do so if the researcher is being funded by the federal government. 
              &lt;p&gt; 
              &lt;p&gt;At HSCI, philanthropists have picked up the tab for some of the research that is not eligible for federal funding. 
              &lt;p&gt; 
              &lt;p&gt;But for institutions less fortunate than HSCI, NIH funding is the only option for embryonic stem cell research, said Dr. Dawson. 
              &lt;p&gt;
              &lt;p&gt;&lt;strong&gt;More Stem Cell Lines, More Ethical Issues&lt;/strong&gt;
              &lt;p&gt; 
              &lt;p&gt;Obama&apos;s executive order won&apos;t mean an end to discussion and rules guiding the ethical collection of new embryos, said Amy Comstock Rick, president of CAMR. Far from it.
              &lt;p&gt; 
              &lt;p&gt;&quot;You can do a lot of good with this,&quot; said John Gearhart, Ph.D., director of the Institute for Regenerative Medicine at the University of Pennsylvania. &quot;And you can perhaps do a lot of bad with this when you think about it.&quot;
              &lt;p&gt; 
              &lt;p&gt;To ensure the research is carried out properly, NIH will be assigned to develop ethical standards, said Dr. Battey.
              &lt;p&gt; 
              &lt;p&gt;At a press briefing later in the day, NIH officials said they would solicit public comment and have guidelines ready within 120 days.
    &lt;p&gt; 
    &lt;p&gt;Scientists believe the guidelines are likely to require that all federally-funded research use leftover embryos from in vitro fertilization clinics that would otherwise be destroyed. The guidelines would probably stipulate that the donors couldn&apos;t be paid specifically for their embryos, and the research cannot eventually help treat the embryonic donors.
              &lt;p&gt; 
              &lt;p&gt;Those guidelines have been introduced in Congress a number of times by Rep. Diana Degette (D-Colo.). Lifting the ban has bipartisan support in Congress, which repeatedly passed bills to loosen the restrictions that President Bush established. 
              &lt;p&gt; 
              &lt;p&gt;Degette recently re-introduced the guidelines again to prepare for Obama&apos;s executive order. 
              &lt;p&gt; 
              &lt;p&gt;But Congress isn&apos;t likely to play a huge role in setting  the policy. It&apos;s more likely  to leave the rule-making to the NIH, said CAMR&apos;s Comstock Rick.
              &lt;p&gt; 
              &lt;p&gt;Those opposed to research on human embryonic stem cells say ethics guidelines won&apos;t make up for the fact that the research is destroying human life. 
              &lt;p&gt; 
              &lt;p&gt;There are other ways to research stem cells that don&apos;t destroy embryos, said Yuval Levin, a former adviser to President Bush on HHS, NIH, and the FDA. Levin was also the chief of staff on the president&apos;s council on bioethics. 
              &lt;p&gt; 
              &lt;p&gt;Now that non-embryonic methods of stem cell research are gaining ground, research won&apos;t rely as heavily on embryos as it would have a few years ago, Levin said. 
              &lt;p&gt; 
              &lt;p&gt;&quot;The change in the politics now will have much less impact than it did four or five years ago,&quot; said Levin. &quot;It won&apos;t mean as much embryo destruction as it did four or five years ago. 
              &lt;p&gt;
              &lt;p&gt;&lt;strong&gt;NIH to Fund Three Types of Research &lt;/strong&gt;
              &lt;p&gt; 
              &lt;p&gt;Even with the lifting of the ban, Dr. Battey, the chairman of the NIH Stem Cell Task Force, said he does not expect grant applications to pour in.
              &lt;p&gt; 
              &lt;p&gt;The science is just too young, Dr. Battey said. 
              &lt;p&gt; 
              &lt;p&gt;Comstock Rick disagreed. Scientists are ready for this, she said. 
              &lt;p&gt; 
              &lt;p&gt;The HSCI has used private funds and solicited excess frozen embryos from patients who chose to donate them to get around the Bush order.
              &lt;p&gt; 
              &lt;p&gt;&quot;The lifting of the executive order will allow us to collaborate with people with federal funding, and write joint grant applications with others,&quot; said Dr. Melton in a release, outlining the lab&apos;s plan to do research on cells and neurons involved in Parkinson&apos;s and Alzheimer&apos;s disease. 
              &lt;p&gt; 
              &lt;p&gt;&quot;The removal of this barrier that has stood in our way for eight years will open important new areas of research, and help in moving the field forward more rapidly,&quot; Dr. Melton said. 
              &lt;p&gt; 
              &lt;p&gt;The recently-passed economic stimulus bill contained $10 billion for the NIH. Comstock Rick explained that $8.5 billion could potentially go toward embryonic stem cell research. Of that, some would go toward funding existing grants that scored well, but went unfunded. 
              &lt;p&gt; 
              &lt;p&gt;The money would also fund two-year grants to supplement existing research, which is where the most immediate promise lies, Comstock Rick said. 
              &lt;p&gt; 
              &lt;p&gt;Researchers already using embryonic stem cell lines could expand their research away from the &quot;contaminated presidential lines&quot; and toward new, cleaner, more diverse lines, she said. 
              &lt;p&gt; 
              &lt;p&gt;The third type of grants would be for specific research projects commissioned by NIH -- which worries James Engel, Ph.D., chairman of cell and developmental biology at the University of Michigan Medical School. 
              &lt;p&gt; 
              &lt;p&gt;Dr. Engel fretted that the NIH-initiated projects would emphasize &quot;new, hurry, trendy&quot; research. He would prefer a focus on approving proposals from outside NIH.
              &lt;p&gt;
              &lt;p&gt;Michigan recently followed the lead of states such as California, New York, and Maryland and passed a referendum recently allowing for the creation of new stem cell lines. The University of Michigan has already begun interviewing researchers and feels it can attract much more talent, Dr. Engel said. 
              &lt;p&gt;
              &lt;p&gt;Other researchers agreed that the federal law being overturned will result in U.S. research institutions attracting top talent from around the world. 
              &lt;p&gt; 
              &lt;p&gt;As more scientists turn to embryonic stem cells, they are hopeful the research will advance in a way that wasn&apos;t possible over the past eight years, Dr. Dawson said. 
              &lt;p&gt; 
              &lt;p&gt;&quot;People have been waiting for this for quite a while so we can get on with our jobs and find ways to cure and treat human disease,&quot; Dr. Dawson said. &quot;That&apos;s what we have devoted our lives to.&quot;
              &lt;p&gt; 
              &lt;p&gt;&quot;I&apos;m cautiously optimistic that we&apos;ll begin to see breakthroughs using these cells within the next five years,&quot; said Dr. Engel. 
              &lt;p&gt;
              &lt;p&gt;&lt;strong&gt;States may React to Federal Funding Opening Up&lt;/strong&gt;
              &lt;p&gt;
              &lt;p&gt;While scientists are hoping for the best, they are considering some darker consequences of opening up federal funding for embryonic stem cells. For instance, philanthropists might pull out some funding, which could harm more advanced research since government funding tends to favor basic research, Dr. Scadden said. 
              &lt;p&gt; 
              &lt;p&gt;At a seminar sponsored by the Center for American Progress, Comstock Rick said she worries that states might pass their own restrictive legislation in response to Obama overturning the order. 
              &lt;p&gt; 
              &lt;p&gt;Or, states that funded embryonic research might see a flood of new federal dollars as a signal to slash their own funding, said Dr. Dawson. Michigan, California, and several other states that set up their own programs are now suffering huge recession-driven budget strains. 
              &lt;p&gt; 
              &lt;p&gt;&quot;We&apos;ve started to make some progress in these states,&quot; she said. &quot;If the states pulled back now, it would really stall the forward momentum.&quot;
              &lt;p&gt; 
              &lt;p&gt;But rather than looking to the unintended consequences, scientists are focused on what they feel is a new science-based era under President Obama. 
              &lt;p&gt; 
              &lt;p&gt;&quot;I just can&apos;t emphasize enough the significance of what I think a new presidency will bring,&quot; said Penn&apos;s Dr. Gearhart. 
              &lt;p&gt; 
              &lt;p&gt;Scientists need to engage in policy more than before to prevent lawmakers slapping down restrictions on sound science, said Dr. Gearhart. 
              &lt;p&gt; 
              &lt;p&gt;&quot;We cannot let this kind of thing happen again. We just can&apos;t,&quot; said Dr. Gearhart. (See: &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/12575&quot; target=&quot;blank&quot;&gt;Clinical Trial of Stem Cells for Spinal Cord Injury Cleared by FDA&lt;/a&gt;)
              
    </recommendedItem>
    <recommendedItem id="20090101_19_1183"
                     title="NIH Guidelines Put Limits on Embryonic Stem Cell Research"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/tb/13799?impressionId=1265781938742"
                     
       WASHINGTON, April 17 -- Federally funded research on human embryonic stem cells will be restricted to leftover embryos from in vitro fertilization procedures with the parents&apos; consent, under draft guidelines issued today by the National Institutes of Health (NIH). 
              &lt;br&gt; 
              &lt;br&gt;The new guidelines could mean an additional 700 embryonic stem cell lines will be available for research soon -- a massive increase from the current 21 -- according to an estimate from Raynard Kington, M.D., Ph.D., acting director of NIH. 
              &lt;br&gt; 
              &lt;br&gt;The proposed guidelines are a &quot;remarkable development,&quot; according to Dr. Kington -- and a major change from Pres. George W. Bush&apos;s policy that wouldn&apos;t allow federal funding to create new embryonic stem cell lines. 
              &lt;br&gt; 
              &lt;br&gt;&quot;This represents unequivocally some great opportunities for advancement in this field,&quot; Dr. Kington said during a press call Friday.
              &lt;p&gt; 
              &lt;p&gt;But he said the new policy draws the line at creating human embryos solely for research.
              &lt;p&gt; 
              &lt;p&gt;&quot;There is not a consensus in the scientific community that would warrant [that] step,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt;Somatic cell nuclear transfer, which can be used for reproductive cloning, will also be ineligible for federal funding. So will research seeking to introduce human embryonic stem cells into nonhuman primate blastocysts or for breeding animals in which human stem cells may have contributed to the germ line.
              &lt;p&gt; 
              &lt;p&gt;&quot;There is strong support for IVF-derived cells,&quot; Dr. Kington said, adding that Congress twice passed bills with language similar to the new draft guidelines. &quot;There is not similar broad support for using it for other purposes,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt;Dr. Kington said he wasn&apos;t aware of any embryonic stem cell lines in existence that were derived from somatic cell nuclear transfer or were created solely for research. 
              &lt;p&gt; 
              &lt;p&gt;&quot;There [are] a lot of promises for other sources of stem cell lines, but we&apos;re so excited these new sources will open up,&quot; Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, told &lt;em&gt;MedPage Today. &lt;/em&gt;
              &lt;p&gt; 
              &lt;p&gt;The NIH draft guidelines were issued in response to the executive order issued by Pres. Barack Obama in March that rescinded his predecessor&apos;s more restrictive policy. Obama&apos;s guidelines tasked the NIH with drafting rules to guide &quot;scientifically worthy and ethically responsible research.&quot;
              &lt;p&gt; 
              &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/13170&quot; target=&quot;blank&quot;&gt;Obama Lifts Embryonic Stem Cell Restrictions&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;Under the draft guidelines, conditions for federal funding of embryonic stem cell research also include:
              &lt;p&gt; 
              &lt;ul type=&quot;disc&quot;&gt;
                &lt;li&gt;The donor must consent to giving the excess embryos to researchers
                &lt;li&gt;Consenting to or denying embryo donation must not affect the quality of care received at the in vitro clinic
                &lt;li&gt;Medical personnel at the in vitro fertilization clinic must explain to the donor all other options pertaining to embryos that are no longer needed
              &lt;/ul&gt;
              &lt;ul type=&quot;disc&quot;&gt;
                &lt;li&gt;Donors cannot be paid or given other financial inducements to donate embryos
                &lt;li&gt;There must be a &quot;clear separation&quot; between the decision to create embryos for reproductive purposes and for research purposes 
                &lt;li&gt;The clinician creating embryos during in vitro fertilization cannot also perform research on them
                &lt;li&gt;The research cannot provide direct medical benefit to the donor (such as creating stem cells that would then be used to treat the donor&apos;s own disease)
              &lt;/ul&gt;
              &lt;p&gt; 
              &lt;p&gt;Dr. Kington said researchers can begin submitting grant applications now, but the agency will hold off on reviewing applications until it issues its final rule, expected in July.
              &lt;p&gt; 
              &lt;p&gt;Applications already submitted can be modified after the final rule, he said. 
              &lt;p&gt; 
              &lt;p&gt;The draft guidelines were posted today on the NIH website (&lt;a href=&quot;http://stemcells.nih.gov/policy/2009draft.htm&quot; target=&quot;blank&quot;&gt;Stem Cell Information&lt;/a&gt;).
              &lt;p&gt; 
              &lt;p&gt;They will be open for comment for 30 days after they are formally published in the Federal Register, scheduled for April 24.
              &lt;p&gt; 
              &lt;p&gt;A statement from the Harvard Stem Cell Institute, a major player in embryonic stem cell research, said the group will review the guidelines and post a comment. 
              &lt;p&gt; 
              &lt;p&gt;&quot;We strongly support the development of unambiguous, ethically sound regulation of the field of embryonic stem cell research, and will carefully consider these proposed guidelines and offer detailed response during the public comment period,&quot; according to the statement.
    </recommendedItem>
    <recommendedItem id="20090101_19_1256"
                     title="Pluripotent Stem Cells Created from Adult Cells Without Gene Transfer"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/tb/13892?impressionId=1265781938742"
                     
      WHEELING, W.Va., April 24 -- Adult mouse cells were reprogrammed into pluripotent stem cells with recombinant transcript factor proteins instead of genes, researchers said.
              &lt;p&gt; 
              &lt;p&gt;The approach, if it can be replicated successfully in human cells, could alleviate a major concern about clinical uses of induced pluripotent stem cells -- namely, that unnatural genes used in the reprogramming could cause cancer or other problems.
              &lt;p&gt; 
              &lt;p&gt;Using proteins to redirect the phenotype of adult cells into an embryonic stem cell-like state &quot;effectively eliminates any risk of modifying the target cell genome by exogenous genetic sequences, which are associated with all previous induced pluripotent stem cell methods, wrote Sheng Ding, Ph.D., of the Scripps Research Institute in La Jolla, Calif., and colleagues online in &lt;em&gt;Cell Stem Cell&lt;/em&gt;.
              &lt;p&gt; 
              &lt;p&gt;Dr. Ding and colleagues added that the approach is simpler and faster than gene-transfer methods and is likely to be more economical as well, &quot;given the robustness and wide availability of large-scale recombinant protein production.&quot;
              &lt;p&gt; 
              &lt;p&gt;The general approach to transforming adult cells into pluripotent stem cells has been to introduce transcription factors associated with early mammalian development. The idea -- since realized by several research groups including Dr. Ding&apos;s -- is to cause the cells to revert to an immature state like that of cells in embryos and developing fetuses.
              &lt;p&gt; 
              &lt;p&gt;Earlier methods had used genes to produce these transcription factors. Most recently, a group at the Whitehead Institute in Cambridge, Mass., used genes contained in plasmids to express transcription factors without altering the target cells&apos; genomes. (See &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/13133&quot; target=&quot;blank&quot;&gt;Stem Cell Research Takes Another Step Forward&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;The Whitehead researchers apparently were able to remove the genetic material following transformation. But it remained uncertain that such removal could be guaranteed in all cells used in potential clinical applications.
              &lt;p&gt; 
              &lt;p&gt;Researchers thus far had avoided using transcription factor proteins themselves because they are extremely short-lived and subject to rapid degradation in the cellular environment.
              &lt;p&gt; 
              &lt;p&gt;Dr. Ding and colleagues got around the problem by using recombinant methods to fuse the four key transcription factors -- &lt;em&gt;Oct4&lt;/em&gt;, &lt;em&gt;Klf4&lt;/em&gt;, &lt;em&gt;Sox2&lt;/em&gt;, and &lt;em&gt;c-Myc&lt;/em&gt; -- with a polyarginine peptide. 
              &lt;p&gt; 
              &lt;p&gt;This peptide had previously been shown to effectively protect various proteins against degradation long enough for them to work at least briefly in cells.
              &lt;p&gt; 
              &lt;p&gt;The researchers were able to use this approach to successfully transform mouse fibroblasts into pluripotent stem cells.
              &lt;p&gt; 
              &lt;p&gt;The transformed cells were able to form embryoid bodies and to differentiate into cells characteristic of the three primary germ layers: endoderm, mesoderm, and ectoderm. 
              &lt;p&gt; 
              &lt;p&gt;The cell types correspond to such mature cells as hepatocytes, cardiomyocytes, and neurons, respectively.
              &lt;p&gt; 
              &lt;p&gt;Transformed cells could also incorporate into the inner cell mass of a blastocyst.
              &lt;p&gt; 
              &lt;p&gt;In all, the in vitro and functional characteristics of the transformed cells were virtually identical to those of mouse embryonic stem cells, Dr. Ding and colleagues said.
              &lt;p&gt; 
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;Funding information for the study was not reported.
              &lt;p&gt; 
              &lt;p&gt;Some authors of the study were employed in private industry, including ProteomTech and LD Biopharma. Other potential conflicts of interest were not reported.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
             
    </recommendedItem>
    <recommendedItem id="20090101_19_2117"
                     title="Early Cardiac Stem Cells Identified"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/tb/14958?impressionId=1265781938742"
                     
       LITTLE FALLS, N.J., July 5 -- The earliest master stem cells that form the three major cell types in the human heart have been identified and isolated, researchers said.
              &lt;p&gt; 
              &lt;p&gt;&quot;This is a very simple, but very important and fundamental finding,&quot; according to Kenneth Chien, MD, PhD, of the Harvard Stem Cell Institute and Massachusetts General Hospital in Boston, who led the effort.
              &lt;p&gt; 
              &lt;p&gt;Reporting online in &lt;em&gt;Nature&lt;/em&gt;, he and his colleagues described the process of isolating and purifying islet progenitor cells -- called ISL1+ progenitors -- from human embryonic stem cells.
              &lt;p&gt; 
              &lt;p&gt;These cells expand and then differentiate into heart muscle, smooth muscle, and endothelial cells during early cardiogenesis, a process that hadn&apos;t been well understood previously, according to Dr. Chien.
              &lt;p&gt; 
              &lt;p&gt;He said the findings could have clinical implications in the future, particularly in the treatment of congenital heart disease, the regeneration and repair of damaged tissue following myocardial infarction, and the development of a human model to study heart disease and the effects of medications.
              &lt;p&gt; 
              &lt;p&gt;&quot;It would be empowering to have human models of human cardiovascular disease,&quot; Dr. Chien said.
              &lt;p&gt; 
              &lt;p&gt;But on a conference call with reporters, he urged caution in interpreting the findings, which he said lay the groundwork for future studies.
              &lt;p&gt; 
              &lt;p&gt;&quot;I don&apos;t want this to come across as hype,&quot; he said. &quot;I think there is some promise here. . . . But by no means do I believe that this cell or any of the cells described in this are ready for a clinical trial.&quot;
              &lt;p&gt; 
              &lt;p&gt;The current study extends the findings of previous studies Dr. Chien&apos;s group conducted in mice. (See &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/469&quot; target=&quot;blank&quot;&gt;Cardiac Stem Cells May Help Repair Heart Defects&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/4578&quot; target=&quot;blank&quot;&gt;Cell Findings Go to Heart of Heart Development&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;The study helped answer the question of how a newborn human heart grows to 1,000 times the size of a newborn mouse heart, despite similar initial embryo sizes.
              &lt;p&gt; 
              &lt;p&gt;Dr. Chien said the study showed that these master stem cells first expand, persisting until later stages of development in humans than in mice, and then differentiate into the three cell types.
              &lt;p&gt; 
              &lt;p&gt;Identifying and isolating these master stem cells in humans will allow rigorous study into the pathways by which they differentiate into the major types of cells, Dr. Chien said, and intermediate cells in these pathways will be the most likely candidates for stem cell therapies in the future.
              &lt;p&gt; 
              &lt;p&gt;Isolation of this master stem cell &quot;forms the basis for finding the downstream intermediate within its pathway to identify the means by which to isolate it and to grow it,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt;The progenitors are concentrated in &quot;hotspots&quot; for congenital heart disease, including the outflow tracts that connect to the pulmonary artery and aorta.
              &lt;p&gt; 
              &lt;p&gt;&quot;A stem cell-mediated process clearly exists for expansion of the human heart,&quot; Dr. Chien said, &quot;particularly in regions that are affected by congenital heart disease.&quot;
              &lt;p&gt; 
              &lt;p&gt;This suggests, he said, &quot;that congenital heart disease may be a stem cell disease.&quot;
              &lt;p&gt; 
              &lt;p&gt;Developing human models from the progenitor cells could aid in the search for treatments for diseases such as Duchenne muscular dystrophy, DiGeorge and Down syndromes, and rare genetic congenital heart diseases, Dr. Chien said.
              &lt;p&gt; 
              &lt;p&gt;In addition, understanding how the heart develops could help researchers find ways to augment undamaged cardiac muscle mass after myocardial infarction or the development of heart failure, he said.
              &lt;p&gt; 
              &lt;p&gt;&quot;To understand how human cardiogenesis occurs is actually the blueprint for a new approach to regenerative therapy using these stem cells as opposed to already differentiated muscle cells,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt; The study was supported by the Harvard Stem Cell Institute and the Leducq Foundation. Advanced Bioscience Resources provided the human fetal tissues used in the study. 
              &lt;p&gt;One of the study authors is funded by Foundation Alfonso Martin Escudero in Spain.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
    </recommendedItem>
</recommendedContent>