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Embryonic Stem Cell Study Approved
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Stem cell therapy is a promising line of treatment for many diseases, conditions, and injuries. Neurological injuries, including injuries to the spinal cord, are difficult to treat, as neurons are not easily replicated in vitro or in vivo. Embryonic stem cells are able to mature into any cell of the body, including neurons. Stem cells could therefore be particularly useful in treating spinal cord injuries, Parkinson’s disease, and other neurological defects.

Embryonic stem cell therapies have previously been tested in animals, such as rats and mice. Previously, scientists have been able to mature human embryonic stem cells into dopamine producing cells. The dopamine producing cells were then transplanted into rats in order to treat Parkinson’s disease-like symptoms. While this treatment showed efficacy in the rats, translating such advancements to humans is very difficult. Embryonic stem cells have also been injected into mice that had spinal cord injuries. The treatment allowed partially paralyzed mice to begin walking again. Animal studies are useful for determining potential clinical efficacy. However, the artificial nature of the condition being studied using animal studies may not adequately depict the conditions in a human. For treatments such as spinal cord repair, scientists still need to learn more about how neurons are able to communicate with each other in order to achieve optimum results in human patients. In addition, because most animal studies are relatively short term compared to the life of the human, it can be difficult to gauge any long term effects from embryonic stem cell treatments.

The Food and Drug Administration (FDA) has granted approval for the first clinical trial using embryonic stem cells. The trial will test safety of stem cell treatments in patients with spinal injuries. Patients in the study have suffered complete spinal cord injury, in which there is no currently available treatment to restore function below the injury. The stem cells used in the trial are among those authorized for research during the Bush-era restriction on funding embryonic stem cell research. The main purpose of the study is to determine safety. Because embryonic stem cells have not been used yet in a clinical setting, any side effects are not yet known.

Because retrieval of embryonic stem cells requires the destruction of the four to five day old embryo, the use and study of embryonic stem cells is controversial. The stem cells used in the study were obtained from embryos left over after in vitro fertilization treatments, and would have otherwise been destroyed. The stem cells retrieved from the embryo are able to develop into any type of cell in the body. As stated above, the stem cells are among lines approved for research when Bush-era federal funding restrictions on embryonic stem cell research were instated. These lines are concerning to some researchers, as they may not be considered purely human cells. Many of these cell lines were maintained using mouse-origin feeder cells. In addition, because the cells have been maintained in culture for such a long period, they may lost some of their ability to mature into varying cell types, or even accumulated unnoticed mutations. Tumor production by transferred embryonic stem cells is another concern. If the cells have indeed mutated, and are injected into a human, the mutation might cause the embryonic stem cells to replicate rapidly, thus becoming cancerous.

The study will involve a small number of patients who have been completely paralyzed due to spinal cord injury. The will receive embryonic stem cells that have been matured in vitro into a type of cell that might be able to replace the damaged nerve cells in the spinal cord. The patients will be monitored for one year after receiving the therapy to see if there has been any recovery, in addition to monitoring for side effects from the treatment. This first test of embryonic stem cells in patients is a massive step forward for future treatments using embryonic stem cells. Scientists and clinicians will begin to determine proper dosing, implantation, and be able to identify major safety concerns. While there are many concerns regarding the safety and efficacy of embryonic stem cell therapy, the promising treatments that could be developed help justify the early risk as clinical trials begin.


References:

http://www.cnn.com/2009/HEALTH/01/23/ste...index.html

http://www.cnn.com/2008/HEALTH/12/22/ste...index.html

http://www.stemcelltherapies.org/safety.htm
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