May 10, 2011 /RTPR/– Advanced Cell Technology with laboratory facilities in Marlborough Massachusetts has pioneered a solution to the ethical, moral & legal debate raging in regards to protection of a human embryo. ACT has developed the “single-blastomere” technique. Patent Number 7,893,315 a non-destructive alternative for deriving human embryonic stem cell (hESC) lines.
This achievement in Regenerative medicine is a ground breaking feat for both Catholic and U.S. law.
• The 1995 encyclical The Gospel of Life, of which Pope John Paul II wrote: “Human embryos obtained in vitro are human beings and are subjects with rights; their dignity and right to life must be respected from the first moment of their existence. It is immoral to produce human embryos destined to be exploited as disposable ‘biological material'” (1,5 )
• The Dickey Amendment (also known as the Dickey-Wicker Amendment) is the name of an appropriation bill rider attached to a bill passed by United States Congress in 1995, and signed by former President Bill Clinton, which prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed.
The single-blastomere technology uses a one-cell biopsy approach similar to pre-implantation genetic diagnosis (PGD), which is widely used in the in vitro fertilization (IVF) process and does not interfere with the embryo’s developmental potential. The stem cells generated using this approach are healthy, completely normal, and differentiate into all the cell types of the human The safety record for one-cell biopsy as part of PGD now has a 15-year track record, and is carried out routinely as part of IVF processes around the world. ACT’s technique of protecting the human embryo from harm can be expounded to the smallest blood transfusion in the world. As does a human being give millions of blood cells in a pint of blood so does ACT’s “single blastomere” process take but “one cell” from a 2 day old embryo. As the blood removed from a human donor “regenerate” the removed pint of blood so does the human embryo “regenerate” the one cell. Both of these procedures leave the human body & two day old embryo healthy. Both procedures are similar in that they both provide life saving material to those whom need them most to due to disease and other aliments of a medical nature.
Advanced Cell Technology has been granted by the US Food and Drug Administration (FDA) a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells for both Stargardt’s Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world and Dry Age-Related Macular Degeneration (AMD) the most common form of macular degeneration in the world affecting an estimated 150 million people. ACT is using RPE cells developed from the patented (SCB) technique for this trial. The trial will take place at UCLA’s Jules Stein Eye Institute in California. Because of the biological nature of the human eye the trial will be able to provide a 100% irrefutable proof that the (hESC) derived RPE cells used attached to the Bruch’s membrane. Before and after state of the art imaging will take place.
Raymond Lund, Ph.D., a scientific collaborator with ACT, and considered one of the world’s foremost experts in retinal cell physiology and vision restoration, commented, “The study results of ACT’s RPE cells implanted in the various animal models of macular degeneration was phenomenal. If ACT observes even a fraction of that benefit in humans, it will be nothing short of a home run.”
FDA validation will occur for (hESC) medicine in less than 12 months. Will those that dictate law and morality to others lead? Will those suffering from disease all over the world finally have conclusive proof that (hESC) work? Life is filled with multifaceted choices and in a rare occurrence a quantum leap shows itself to the world. Human flight, computers and now regenerative medicine.
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