FDA Gives Stem Cell Research Green Light
In 1998, Jamie Thomson developed the very first stem cells at the University of Wisconsin-Madison. Since that discovery, controversy and criticism has surrounded sciences involving the use of stem cells, particularly medical research. The US Food and Drug Administration has set all that aside however, and approved the first human trial of a human embryonic stem cell treatment.
The corporation Geron has received permission to test stem cells in patients with severe spinal injuries to see if the treatment is safe in humans. No other company has ever been granted this approval by the FDA. Thomas Okarma is the CEO and president of Geron, and he's ecstatic about the possibilities of the new study. "A complete spinal cord injury has no hope of recovery below the injury," Okarma says"This is significant because it's the first clinical trial of a human embryonic-based product."
The main intention of this study is to look at the safety of the injections used to insert the stem cells into the spine, however the test patients will also be monitored to see if any recovery occurs. The researchers involved in the study have developed oligodendrocytes, which is a big fancy word for a cell that produces myelin, the protective covering of nerves. They hope that by providing patients with stem cells capable of this, spinal injuries may have a chance of recovering.
Before going to the FDA, researches conducted animal trials and studied cells in petri dishes. Getting approval from the FDA was difficult because there was no precedent set for a human embryonic-based product. Other companies hope to follow suit and pursue embryonic stem cell research. Regulations put in place by the Bush administration made stem cell research very difficult until 2001 when regulations were loosened slightly. Now with President Obama in office, restrictions are expected to be lifted, making it easier for companies to pursue stem cell knowledge.
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