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The National Institutes of Health (NIH) today released draft guidelines that permit federal funding for research on stem cells from human embryos set to be discarded by fertility clinics.

Under the new regs, the agency would fund studies on embryos created in test tubes — but no longer needed — for reproductive purposes, adult stem cells and induced pluripotent stem cells (skin or other adult cells that are nudged back into their pluripotent state, when they have the potential to become any cell type). Fertility patients would have to consent to their leftover embryos being donated for research.

The rules bar funding for research on embryos created expressly for stem-cell studies; ditto for studies involving embryos derived from somatic cell nuclear transfer (replacing the nucleus of an unfertilized egg with genetic material from another body cell and stimulating it to divide) or parthenogenesis (reproduction without fertilization).

"This is an incredible opportunity for the scientific community and the health of the people [who may benefit] by what we learn from this additional science," Raynard Kington, NIH's acting director, said during a teleconference with reporters today. Scientists believe that embryonic stem cells, which have the ability to morph into any type of tissue in the human body, could one day be used to treat conditions such as diabetes and Parkinson's disease.

Former President George W. Bush banned federally funded research on embryonic stem-cell lines created after Aug. 9, 2001. On March 9, President Obama lifted the ban and gave the NIH 120 days to craft guidelines governing such research. Scientists complained that Bush's ban limited research to about two dozen stem-cell lines of varying quality. But there may now be some 700 embyronic stem-cell lines that would qualify for federal funding under the new guidelines, Kington said. (Congress passed legislation twice calling for the limit to be lifted on stem cell research, but Bush vetoed both bills.)

The proposed new regs disappointed some who said the prohibition on funding of embryos created specifically for research could hamper the creation of treatments such as organ tissue genetically matched to prospective transplant recipients, the New York Times notes.

"The proposed guidelines limit some very promising avenues of current research and limit the genetic diversity of the stem cell lines that will be eligible for federal funding," Susan Solomon, CEO of the nonprofit New York Stem Cell Foundation, said in a statement. "This is a very young field, with the promise to combat the most deadly diseases of our time. Scientists need to be able to deploy a full arsenal, one that encompasses what may be possible in the future."

Two colonies of human embryonic stem cells carrying the mutation causing Marfan syndrome, derived from a donated IVF blastocyst/Lab of Julie Baker, Stanford University School of Medicine courtesy of California Institute for Regenerative Medicine

1 Comments

1. 1. quiact 09:59 AM 4/20/09

   Over 100 years ago, a Russian histologist suggested stem cells be applied for scientific research. They are the human body’s equivalent of a generator, as they can renew, regenerate, and replicate under the right conditions.
   
   The apex of cellular therapy and regenerative/reparative medicine has been reborn after an 8 year moratorium that basically halted federal funding for stem cell research with most states in the U.S.
   
   Now the NIH can award grants to scientists involved with biomedical research involving stem cell therapy through the CMS to each state in the U.S.
   
   While never banned, stem cell research had limited funding during this time. And this was unfortunate, because there are several likely uses of stem cells.
   
   These uses include the replacement of tissues in the human body, as well as repairing cell types that are defective. Also, stem cells can deliver genetic therapies that are needed in certain patients.
   
   ESCs are totiplotent if obtained from the morula which is a pre-blastocyst stage. Normally, the stem cells are acquired from the blastocyst itself. From this source, the stem cells can be any cell in the human body except for the placenta, and are pluripotent.
   
   Embryonic stem cells are obtained from a 4 day old embryo called a blastocyst, and are pluripotent from this source. The blastocyst contains about 100 cells, and is not suitable at this stage for implantation into the uterine wall.
   
   The inner core of the blastocyst has about 20 cells, and this is where stem cells are obtained.
   
   These cells are unspecialized cells that can be developed or morphed into the over 200 cells available in the human body through differentiation, as ESCs are undifferentiated by nature.
   
   As such, they can become any human cell, as long as they are prevented from clumping or crowding together when explanted into cultures as they are propagated. After stem cells are cultured, they are moved to what are called stem lines.
   
   Until recently, ESCs were believed to be most beneficial instead of the adult stem cell alternative (ASC), as these stem cells are limited to application to the tissue the stem cells were obtained from only. However ASCs (somatic stem cells) now can be coerced into differentiation through plasticity (trans-differentiation). This likely will reduce if not eliminate those opposed to stem cell therapy because of moral and ethical reasons related to the utilization of ESCs.
   
   Thanks to molecular biology, four transcription factors control the transfer of genetic information from DNA to RNAS to regulate gene expression. So ASCs can have the same beneficial qualities as ESCs.
   
   In the past, viral vectors and exotic genes interfered with the purity of ASCs. Now ASCs are re-programmed using plasmids instead of viruses and oncogenes that can become detrimental for the patient treated.
   
   So now, ASCs can safely become induced pluripotent cells with the same potential as ESCs. As a result, the ASCs are free of genetic artifacts that potentially can interfere with transgene sequences.
   
   They are capable of, and are able to renew and reproduce with minimal effort, stem cells, under the right laboratory conditions.
   
   Human blood can be reproduced with stem cells under the right conditions, it has been shown by researchers.
   
   SCT can also be used to investigate disease states for better treatment options.
   
   Disease-specific stem cell lines, which are those cells that are pluripotent and are created with the same genetic errors of certain diseases, are studied for this reason.
   
   So there clearly is a huge potential for stem cell-based therapies. The first FDA approved clinical trial occurred early in 2009. This human trial will involve evaluating primarily the safety of ESCs designed to be used as treatment for spinal cord injury patients. The trial was submitted by Geron Corp.
   
   Pfizer, the largest drug company, has implemented stem cell research, as they are an asset to drug discovery by creating within the organization a regenerative medicine unit. Other large pharma companies are implemented similar research protocols for the same reasons.
   
   Geron Corp. in California is the world’s leading esc developer, and financed researchers at Univ. of Wisconsin, who isolated the first human esc in 1998.
   
   Stem cell therapy potentially can cure multiple sclerosis, among other disases and those with damaged human tissue. The therapy prevents the advancement of disease, as well as reverses the neurological dysfunctions associated with MS. Patients are injected with their own stem cells obtained from their bone marrow, which are called haemopoietic stem cells.
   
   These particular stem cells are the origin of all blood cells. Further large clinical trials are needed to support these results. Studies have shown between 70 and 80 percent of MS patients who received stem cell therapy did not relapse afterwards.
   
   

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