BETHSADA, Maryland, November 22, 2010 (LifeSiteNews.com) – The US Food and Drug Administration has given the go-ahead for a company to begin clinical trials for a therapy derived from human embryonic stem cells (hESCs). The efforts of the Marlborough, Massachusetts-based Advanced Cell Technology (ACT) are being funded in part by the new national health care reform law.
The approval for ACT’s clinical trials marks the second time federal regulators have approved a therapy derived from the stem cells of destroyed human embryos for testing on human subjects.
The company announced earlier in November that the federal government awarded them nearly $1 million in grant money for their embryo-destroying research, thanks to the Patient Protection and Affordable Care Act (PPACA), also known as ObamaCare.
Each of ACT’s four programs, according to a press release, received $244,479.25: the Blastomere Program, the Myoblast Program, the RPE Program for Stargardt’s Disease, and the iPS Program.
ACT will be testing the safety of its therapy for Stargardt’s disease, juvenile macular degeneration that is estimated to effect 1 out of 10,000 youths in the United States. The disease mainly occurs in children between the ages of 10 – 20.
Vision loss occurs when the retinal layer called the retinal pigment epithelium (RPE) begins to break down.
The ACT therapy would replace degenerated RPE cells with new RPE cells produced from human embryonic stem cells. The FDA approved ACT’s application only after the company said its embryo cell technique eliminated the danger of tumor-causing cells. Past attempts at using embryo-derived cells have been plagued by the onset of tumors.
Phases I and II of the trial will involve 12 individuals over 18 years old receiving injections directly into the eyes.
“We’ve tested these cells in animal models of eye disease. In rats, we’ve seen 100 percent improvement in visual performance over untreated animals without any adverse effects,” said Dr. Robert Lanza, ACT’s Chief Scientific Officer.
“We hope to see a similar benefit in patients with various forms of macular degeneration.”
However, ACT is also poised for major profit-making from its hESC therapy. Earlier in the year, the FDA deemed that the RPE cell therapy will have “Orphan Drug” designation. This means the company will have access to tax credits, grants, and seven years of exclusive marketing of their product in a global market which the company believes to represent $25-30 billion dollars.
The only other company with approval for hESC trials in human beings is the California-based Geron Corp., which is conducting safety tests in patients with spinal cord injuries less than 14 days old.
Critics of embryonic stem cell research have pointed out that, aside from destroying human lives at a very early stage of development, so far it has yielded little therapeutic benefit and has struggled to overcome the tendency for such cells to produce tumors. Embryonic stem cell research has been massively outstripped by breakthroughs in adult stem cell research, which has yielded dozens of therapies and benefits for previously untreatable conditions.