January 5, 2011 (LifeSiteNews.com) - The U.S. Food and Drug Administration (FDA) has given the go-ahead to Advanced Cell Technology (ACT), Inc. to conduct a clinical trial using embryonic stem cells.
The cells will be used in an attempt to treat Dry Age-Related Macular Degeneration (AMD), a common cause of vision loss. According to ACT, the condition afflicts between 10-15 million Americans.
The approval marks the second time that ACT has obtained permission to perform a clinical trial with embryo-derived cells. In early November ACT announced that it would be testing the safety of its therapy for Stargardt’s disease.
The company had also announced 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.
“ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine,” said Gary Rabin, Interim Chairman and CEO of ACT this week. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques.”
Besides the ethical pitfalls, past attempts at using embryonic cells for therapies on humans have also led to highly unpredictable results, including the growth of cancerous tumors due to tissue rejection.
ACT’s Phase I/II trials will study the safety of using the cells for sub-retinal transplantation into patients with Dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites.
ACT also announced that it is seeking permission in Europe to conduct clinical trials.