(dailyRx News) The FDA has cleared the way for researchers to begin the first experiments using embryonic stem cells on humans who suffer from spinal cord injury and blindness.
The goal of the studies is to assure safety rather than restore mobility or sight. Still, the FDA approval marks a momentous advance amid an ongoing, contentious ethics debate.
Embryonic stem cells -- a basic group of cells that have the capacity to regenerate themselves -- hold promise for the treatment of debilitating and deadly conditions, ranging from motor neuron diseases, such as amyotrophic lateral sclerosis (ALS), to blindness.
For more than a decade, the use of embryonic stem cells for medical-research purposes has been championed by some, like actor Michael J. Fox, who believes the cells may advance Parkinson's disease therapy, and derided by others because the practice involves the disposal of human embryos.
President Bush outlawed federal funding for embryonic stem cell research during his tenure, a prohibition President Obama soon reversed after entering office in 2009. However, Judge Royce Lamberth blocked US government funding in August of this year. Funding has since been permitted pending an appeal of the ruling.
A recent study from the Georgia Tech Institute of Technology found that an increasing amount of embryonic stem cell research is funded by states rather than the federal government. While the federal government contributes more funds overall to the research, since 2007, six states have funded more research than federal offices.
Meanwhile, in October, Geron Corporation announced it began the first-ever testing of embryonic stem cells on a patient suffering from spinal-cord injury. About a dozen patients are expected to participate in the study, though scientists remain cautious the cells could transform into tumors.
Clinical trials at Advanced Cell Technology (ACT) are under way after the FDA's approval for testing cells in patients with Stargardt's disease, a rare form of blindness that strikes in childhood.
If methods at Geron Corporation and ACT prove safe, the companies plan to expand trials to more diverse populations in hopes of curing paralysis and blindness.
After a decade of debate mired in controversy, the stem-cell field is ready to prove itself, said Bob Lanza, chief scientist at ACT, "and help patients with a range of horrific diseases."
To maneuver around legislation hold-ups and legal wrangling, researchers forged ahead to create induced pluripotent cells (iPS), which are able to transform into skin, blood or heart cells. These cells are less effective than embryonic stem cells, however, according to research.