Saturday, January 24, 2009

HooRay! FDA Approves First Clinical Trial Using Human Embryonic Stem Cells


In a major development awaited by millions of American citizens for a number of years; The United States Food and Drug Administration announced yesterday that it would now allow the very first clinical trial study to commence using the stem cells obtained from a human source.

Although the decision by the FDA comes on the heels of former-President Bush's departure from office this past Tuesday, January 20th, 2009, FDA officials were quick to point out that politics played no role in the decision. This may be the official position of the FDA, however, the agency had to be well aware that if the decision had been made while Bush was in office, it would have faced certain rejection. With Obama now president such considerations became inconsequential to FDA administrators.

The use of human embryonic stem cells holds such importance because the current use of stem cells from adult and fetal sources exhibit an inability to match the many different types of tissue produced. On the other hand, human embryonic stem cells display the rare ability to form any particular kind of cell found in the human body; making their usefulness much greater than the stem cells the Bush administration had approved for study. It is a well known fact that embryonic stem cells provide the body with the foundational building blocks needed for producing all of the blood, organs, and tissues needed to establish and maintain human life.

Geron, a Menlo Park, California-based biotechnology firm, is scheduled to begin its research using eight to ten individuals who suffer from acute types of spinal cord damage. Initially each patient will receive injections of nerve cells, derived from embryonic stem cells called oligodendrocytes, which will encase surrounding axons mending the insulation or myelin, and perhaps also prompting the damaged areas to regenerate. After the injections are made at the spinal injury site it is expected that they will conduct the transmission of electrical signals from the brain to other parts of the body.

If success is proven in the treatment of spinal cord injuries, the use of human embryonic stem cells could establish the field of regenerative medicine, which would mean that such incapacitating diseases as Alzheimer's, Parkinson's and multiple sclerosis could face a more hopeful future of treatment and possible cures.

The cells being used in this initial study represent first human embryonic stem cells ever developed. Researchers had feared those cells could never be used to treat people because they were These initial cells were created from substances collected from cows and mice. Initially researchers feared that the human immune system would reject the cells.

Unfortunately, scientists engaged in stem cell research had to deal with a number of obstacles created in 2001, when former-President Bush preempted the use of animal-free stem cell lines. Bush's decision effectively pushed any embryonic stem cell therapy at least until the end of his term in office that unfortunately lasted until January 20th, 2009. To make the observation that Bush did everything in his power to derail human embryonic stem cell research would be an accurate although unfortunate point of fact. Bush needlessly politicized the topic of stem cells in order to satisfy his most deranged 'pro-life' supporters. In other words Bush made a very stupid and research crippling decision to gain a few votes. Now with Bush out of office FDA decision makers can resume with stem cell research that is safe for humans, and the floodgates will open to allow numerous clinical trials to proceed.

There is also hope that if the initial stem cell treatments do not prove to be completely successful; they could lead to improvements in many disease-stricken and injured people's lives. Regardless of the initial results; there is a considerable amount of optimism among medical researchers and doctors that humankind may be on the verge of initiating a burgeoning era of medical therapeutics in which medical breakthroughs are made at the cellular level obviating the reliance on current pharmaceuticals and surgical implements such as scalpels. Another advantage that presents itself is the possible lowering of medical costs since the cells could be mass produced.

Whatever the case might be, Americans, indeed people around the world must maintain their patience. Advancements in proceedures involving human embryonic stem cell rsearch show tremendous promise for all of humanity. But we must remember, scientific research is a long and tedious process that does not attain progressive developments in a linear manner. Many questions confront us now and more will develop over time. Perhaps the most important development we have achieved in the last few days has been the replacement of Bush the anti-science fanatic; with President Obama, a man who has pledged his complete support for the value of science to humanity in general and his unquestioned affirmation for the supported growth of human embryonic stem cell research in particular.

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