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    <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=1265756747645"
                     
      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_1183"
                     title="NIH Guidelines Put Limits on Embryonic Stem Cell Research"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/StemCellResearch/tb/13799?impressionId=1265756747645"
                     
       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_10_11"
                     title="Harvard Scientists Transform Adult Cells into Embryonic State"
                     score="-0.005"
                     href="