Second Embryonic Stem Cell Trial Approved
A federal agency approved a trial Monday that would use embryonic stem cells to treat rare causes of blindness.
The U. S. Food and Drug Administration gave the green light for a clinical trial to treat 12 patients all diagnosed with Stargardt's Macular Dystrophy, an incurable disease which destroys vision in young children. The trial, to be conducted by Massachusetts biotechnology company Advanced Cell Technology, is the second human trial of embryonic stem cells to be approved in the United States.
"Using stem cells, we can generate a virtually unlimited supply of healthy RPE cells, which are the first cells to die off in SMD and other forms of macular degeneration," ACT Chief Scientific Officer Dr. Robert Lanza said in a company statement.
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Lanza states that ACT scientists have already tested the embryonic stem cells in animal models of the eye disease. He reports that visually impaired rats have experienced 100 percent improvement in visual performance over untreated animals.
"Our studies showed that the cells were capable of extensive rescue of photoreceptors in animals that otherwise would have gone blind … We hope to see a similar benefit in patients with various forms of macular degeneration," expressed Lanza.
ACT received FDA approval through the Orphan Drug Act which designates a special status to products which treats rare diseases and conditions. As a result, ACT will be eligible for tax credits, and grant funding towards the embryonic clinical trial.
ACT Chairman and CEO William M. Caldwell IV calls the use of the embryonic stem cells in this trial a "game changer."
However, Christians call it unethical and immoral.
Embryonic stem cell research is controversial because it requires the destruction of the embryo in order to harvest stem cells. Many religious leaders and pro-life groups, therefore, argue it is an ethics concern and equate the research with abortion because it destroys another potential life.
"Despite the efforts that are made to deny it, science continues to show us that the embryo is a human being in the making," Elio Sgreccia, emeritus head of the Pontifical Academy for Life, said in August.
Southern Baptist Convention's Ethics and Religious Liberty Commission's website states, "Since God, the author and giver of all life, views embryos as full human life, to take this life is an act of murder that God does not approve. In light of this, we as Christians cannot support the destruction of embryos for embryonic stem cell research."
Pro-life advocates do approve of adult stem research using cells taken from bone marrow and umbilical cord blood as an ethical alternative.
While advancements have been made using adult stem cells, researchers continue to push for the use of embryonic stem cells in clinical research.
In July, the FDA approved California company Geron Corperation for a trial using embryonic stem cells to treat spinal cord injury. If Geron's therapy is successful, it has the potential to advance treatments for diseases such as Alzheimer's disease and multiple sclerosis.
Now with the second approved trial of embryonic stem cell-based therapy, ACT is looking to treat degenerative eye diseases that lead to blindness.
As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10 percent of people ages 66 to 74 will have symptoms of macular degeneration, and the vast majority will have the "dry" form of AMD – which is currently untreatable. The prevalence increases to 30 percent in patients 75 to 85 years of age.
The study will begin early next year. Researchers will inject between 50,000 and 200,000 healthy retinal cells derived from stem cells into the eyes of patients.
