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FDA Approves First Human Trials for Embryonic Stem Cell Treatment

By Susan Brinkmann, OCDS Staff Journalist The U.S. Food and Drug Administration (FDA) has approved the world’s first human clinical trial of a therapy involving embryonic stem cells, a move that has been condemned by the Vatican as "unacceptable." The Christian Post is reporting that the California-based Geron Corporation will be allowed to proceed with a trial involving the injection of an embryonic stem-cell treatment into patients suffering from severe spinal cord injuries. The company is hoping the treatment will result in regrowth of damaged nerve cells that will eventually lead to the restoration of movement in the patients. "We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged - to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer's, multiple sclerosis and Canavan disease." However, even proponents of the controversial research are raising concerns about the trial because the same treatment used on animals resulted in a "higher frequency" of cyst development. This worrisome outcome caused the FDA to delay the trials which were originally supposed to take place last summer. The stem cells that will be used in the trial were derived from "left over" embryos stored at a fertility clinic, something that would not have been possible had President Barack Obama not loosened restrictions put in place by President Bush in 2001 on the use of these cells. Elio Sgreccia, emeritus head of the Pontifical Academy for life, told Radio Vatican that the clinic trials were "unacceptable." "Despite the efforts that are made to deny it, science continues to show us that the embryo is a human being in the making."  Embryos are "sacrificed to extract the stem cells from them," Sgreccia argued, saying that such a technique "from an ethical point of view can only receive a negative judgment." The Church emphatically opposes any kind of therapeutic research that relies on stem cells drawn from human embryos, although it is fully in favor of, and is even funding, stem cell treatments derived from the umbilical cord and other parts of the adult body such as the intestine and retina. Adult stem cells are already being used to treat more than 100 conditions with none of the problems, such as increased tumor growth and rejection, associated with embryonic stem cells. The Geron trials are expected to begin sometime this year. © All Rights Reserved, Living His Life Abundantly®/Women of Grace®