FDA Approves First Embryonic Stem Cell Trial 

The pursuit of embryonic stem-cell research is one of the most controversial areas of science, as well as the most ethically debatable issues in American politics. Stem cell research involves the creation use and destruction of human embryonic stems. The contention surrounding the progression of embryonic stem cell research, however promising, centers on the issue that current technology requires the destruction of the human embryo for the extraction of these cells.

An as alternative, extensive research has been conducted over the last two decades using adult stem cells with some success. Although they are limited in flexibility, adult cells do bear some similarities to embryonic stem cells.

Several studies have shown promise in the use of adult stem cells. Genentech scientists in San Francisco were able to grow entire prostates in mice using only a single adult stem cell. A group of researchers at Harvard have discovered a way to convert mature cells to a form that is like an embryonic stem cell.

At Japan’s private Keio University and the National Institute for Child Health and Development, a team has been working on obtaining stem cells from menstrual blood. Yet another project is experimenting with creating stem cells from the testes of men that could be used to grow personalized replacement tissues.

However, even with the advances made with the use of adult stem cells, embryonic stem cells still hold the greatest promise for the most successful medical treatments. As a small example, a group of Harvard Medical School scientists has discovered clues to the mechanism of aging in studies of the embryonic stem cells of mice that could lead the way to preventing or even reversing the process of aging.

Embryonic stem cells are a primitive cell type having the flexibility to be coaxed into developing into any of the 220 types of cells found in the human body. Some of the key cells targeted for research include blood cells, heart cells, brain cells, and nerve cells, among many others. Because embryonic stem cells can only be derived from human embryos, scientists have long anticipated utilizing them to create replacement tissues for the treatment of a broad range of diseases.

Now, in a groundbreaking decision, the U.S. Food and Drug Administration (FDA) has approved the first-ever human trial of a medical treatment derived from embryonic stem cells. The U.S. biotech company known as Geron Corporation, located in Menlo Park, California, plans to begin the world’s first study of a treatment for spinal cord injury that is based on human embryonic stem cells.

According to Dr. Thomas Okarma, president and CEO of Geron Corporation, researchers will be allowed to inject eight to 10 paraplegic patients with cells derived from embryonic cells. Study participants will receive a single injection within two weeks of sustaining their injuries. Okarma explained that each injection would be made in the spine at the site of damage by researchers located in four to seven medical centers across the country. Patients will also receive a low dose of anti-rejection drugs for approximately two months, after which time they should no longer be needed. The study participants will each be followed for at least one year.

The main purpose of the study is to test the safety of the procedure. A major concern is that raw embryonic cells can form tumors when they are put into the body. Although most of these tumors don’t spread like other cancers, any growth in the spinal cord could further damage nerves. During the course of the study, doctors will also watch for and track any signs of improvement including the return of feeling and leg movement.

Prior studies conducted with animals have suggested that injected cells will mature and work to repair the necessary insulation around damaged nerves. In addition, they will release substances that are required for nerves to function and grow. According to a spinal cord injury researcher, Dr. Wise Young of Rutgers University, “a lot of hope of the spinal cord injury community is riding on this trial.”

Orkama stated, “This is the dawn of a new era in medical therapeutics.” He noted that the expectation that stem-cell therapy can repair and regenerate diseased organs and tissue “goes beyond what pills and scalpels can ever do.”

Congress and former President George W. Bush imposed limits on stem-cell research for ethical and religious reasons, which has prevented federal funding. Although the timing of the approval for the study would seem to be connected to President Obama’s entry into office, both Geron and the FDA said this was coincidental. According to Karen Riley, an FDA spokeswoman, “The FDA looks to the science on these types of issues, and we approve based on a showing of safety.” She then added, “Political considerations have no role in this process.”

Geron Corporation is the world’s leading embryonic stem cell developer, claiming exclusive rights on several key stem cell technologies. The company helped to finance the research at the University of Wisconsin in 1998 where human embryonic stem cells were first isolated

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