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New details on Obama's stem cell policy revealed

April 17, 2009 |  2:16 pm

All stem cells derived from excess fertility clinic embryos will be eligible for federal funding under the Obama administration’s new stem cell policy, which was unveiled today.

Stemcell When the president signed an executive order last month lifting his predecessor’s unpopular funding restrictions – which limited money to about 20 stem cell lines that were created before August 2001 – he said he would leave it to the National Institutes of Health to fill in the details. This morning in Bethesda, Md., NIH officials said they intend to make research money available to scientists who work on stem cells made from embryos that are no longer needed for fertility treatments and would otherwise be thrown away.

The proposed policy would make it much easier for scientists to work on hundreds of new cell lines, including some that have been derived from embryos known to have genetic diseases (in fact, that’s why couples declined to implant them). Under the Bush policy, scientists were allowed to work on any human embryonic stem cell lines they wanted as long as none of their supplies – including equipment, lab space or salaries for personnel – were paid for with federal dollars.

Some scientists would also like to get federal funding to try to make stem cells that are genetically matched to patients using a technique called nuclear transfer or therapeutic cloning. To do that, they first need to figure out how to make embryos that are clones of specific patients, then turn those embryos into stem cells.

But a federal law prohibits the government from spending money to create embryos solely for research purposes, and legal experts say Congress would have to overturn that law before the NIH could even consider funding that kind of work.

It doesn’t sound like the Obama administration is eager to do that anyway. In announcing the new policy, acting NIH Director Raynard Kingston emphasized that making use of excess fertility clinic embryos is the only approach that has broad support in Congress and the general public. The policy is in line with the California Institute for Regenerative Medicine’s rules, as well as the Stem Cell Research Enhancement Act, which was passed twice by Congress and vetoed twice by Bush.

The draft guidelines will be published in the Federal Register sometime next week, followed by a 30-day public comment period. (A link for submitting comments online will be made available then; comments can also be mailed to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, MD 20892-7997.) The NIH expects to finalize the funding rules in July.

-- Karen Kaplan

Photo: A researcher removes a colony of stem cells from an incubator at the University of Wisconsin-Madison. Credit: Darren Hauck/Getty Images

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Comments (2)

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.

Allogenic, or donor transplants, have a risk of graft versus host disease. Autologous, which is the patient’s own stem cells, are preferable and most beneficial. Similar results from this autologous bone marrow transplant cellular therapy are seen with Chron’s disease as well.

During the procedure, the immune system is reset so it is not in an autoimmune state where it attacks the human body. The process lasts about 2 months, and consists of 6phases:

1. Initial chemo
2. Release of stem cells
3. Acquisition of stem cells
4. Cells are then frozen until ready for transplant
5. Second chemo to reduce leukocytes
6. Autologous stem-cell transplant. Immune system is reset.

Positive results from stem cell therapy are seen usually within a month, and patients can request another treatment about 6 months after the first treatment presently. This stem cell paradigm of therapy addresses the etiology of a disease state, instead of focusing on the symptoms only. As such, this is the practice of regenerative medicine with the implementation of SCT.

Some believe ethical restraints are needed regarding the use of ESCs for therapeutic reasons. Yet they improve the quality of life of those with devastating diseases which involves suffering without any relief.

So stem cell therapy and research may be the most right and ethical thing to do for such patients. Not only is the tremedous suffering relieved with those possessed with devistating diseases, their functional ability is restored for those who receive stem cell therapy.

Embryos are acquired from fertility clinics (IVFs) that have thousands routinely stored and are abnormally fertilized. This means that they could never go on to become a human, and would be destroyed otherwise.

Ironically, one could argue it is inappropriate to discard what may be valuable and ethical for others, potentially.

Most couples with frozen embryos would gladly give them to such research, surveys have concluded.

These embryos are believed by many to not be morally equivalent to human life, but only have the potential for life. And they are used for therapeutic cloning, known as somatic cell nuclear transfer, and not reproductive cloning.

Ten states have banned this cloning out of ignorance, it seems. Bioethic principles, which are beneficience, or physician-centered decisions, as well as non-maleficence, which is first do no harm, are not corrupted.

Furthermore, autonomy, which is the patient’s right to determine their health, and justice or fairness remain intact.

Stem cells should be utilized for those terminally ill as well, many believe. Many are seeking stem cell therapy overseas due to retrictions that exist in the U.S. presently. The United Kingdom is believed to be the leader in stem cell research presently.

Dan Abshear

Plain and simple - Adult stem cell therapy is ethical, while embryonic stem cell research is unethical since ESCR destroys the embryo. Embryos are human beings. Science supports this fact. Please look into the facts. To do research on live, frozen, human embryos is doing research on living human beings. This type of research is not acceptable in any other form in our society. Why not treat these little humans with respect and bury them. We need to eliminate the problem in IVF clinics where more death occurs than new life. Many abuses occur in IVF clinics, all in the name of bringing new babies to couples who are having problems conceiving. Selective reductions (abortions) account for many deaths in this business. Purposely creating excess embryos for convenience is a terrible abuse of human life. Let's bring back ethics to IVF therapy like it was promised to the American people back in the late 70's when IVF scientists promised in a Congressional hearing that no embryos would be wasted. Let's work to end embryonic stem cell research for the morality of our nation.

Soon after Obama rescinded the Bush embryonic stem cell policy, he also eliminated a past Bush policy to fund adult stem cell research, a proven technology that currently cures over 80 human diseases and conditions. Obama prefers putting our money into embryonic stem cell research, which has not produced any cures. So much for letting science set the agenda. Looks more like politics to me.



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