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First ESCR human trial begins

WASHINGTON (BP)–The first government-approved human trial using cells derived from embryonic stem cells has begun, it was announced Oct. 11.

With approval from the U.S. Food and Drug Administration, Geron Corp. said it had initiated treatment in a patient with a spinal cord injury. The trial, which is the first known use of such cells in a human being, is primarily intended to determine whether it is safe for spinal cord patients or whether they can tolerate it. Geron is not using federal funds in the research.

Embryonic stem cell research (ESCR) is highly controversial, primarily because extraction of such cells results in the destruction of days-old human embryos. ESCR also has been plagued by tumors in lab animals, thereby making its safety for use in human beings highly questionable.

Meanwhile, human trials with adult stem cells not only are safe for the donor and recipient but have produced treatments for more than 70 ailments in human beings.

Pro-life bioethicists did not welcome Geron’s announcement.

“The test of ethical propriety is not whether an experiment works or not, but whether, in this case, the cells were obtained in an ethical manner,” said C. Ben Mitchell, professor of moral philosophy at Union University in Jackson, Tenn., and a consultant to the Southern Baptist Ethics & Religious Liberty Commission. “From our point of view, the experiment is morally tainted if the cells came from embryos who were destroyed for their biological parts.

“Life-saving organs could be derived from killing innocent people, but that would be morally reprehensible,” Mitchell told Baptist Press. “Follow the logic.”

David Prentice, Family Research Council’s senior fellow for life sciences, questioned Geron’s motivation.

The California-based corporation’s “main goal is to increase their stock price and cash flow from investment,” Prentice said in an Oct. 11 blog post. “Not about science, not about helping patients.”

“[S]pinal cord injury patients can show spontaneous improvement within the 3 months after injury, even up to 18 months,” Prentice said. “It will be difficult to determine whether Geron’s injected cells had any real effect. We wish the patient well but think Geron is irresponsible for this premature hype.”

Prentice also pointed out: 1) The cells injected in the patient are not actually growing embryonic stem cells but progenitor or precursor cells derived from embryonic stem cells; 2) Geron knows from two published studies with lab rats the derived cells are not effective in treating chronic spinal cord injuries; and 3) the corporation will have to monitor patients for 15 years because of the unpredictable effect of such cells.

To participate in the trials, a patient must be injected with the cells within 14 days of his spinal cord injury.

The initial patient in the trial is being treated at Shepherd Center, a spinal cord and brain injury hospital and research center in Atlanta. Six other sites in the United States may have patients in the trials, Geron announced.

Human trials with adult stem cells have produced therapies for spinal cord patients that have been shown to be safe and effective — as much as 15 years after an injury, Prentice said.

In all, research with adult stem cells in human trials has produced therapies for 73 afflictions, including cancer, juvenile diabetes, multiple sclerosis, heart damage, Parkinson’s and sickle cell anemia, according to Do No Harm, a coalition promoting ethics in research.

Research with induced pluripotent stem (iPS) cells also has shown promise. This technique, first used in 2006, involves reprogramming adult skin cells into stem cells virtually identical to those in human embryos, though it has yet to be used in human beings.

Scientists at the Harvard Stem Cell Institute in Boston published studies Sept. 30 showing they had reprogrammed adult skin cells into iPS cells without the hazards previously associated with the technique. Unlike previous conversions of adult cells into stem cells, these iPS cells did not require the use of viruses to insert genes into cells — a technique which increases the risk of cancer in the recipient of the cells.

The ability of stem cells, which are the body’s master cell, to convert to other cells and tissues has provided great hope for developing cures for various diseases.

Geron’s announcement was made as a battle over government funding of ESCR is being fought in the federal judiciary. On Sept. 28, the District of Columbia Circuit Court of Appeals ruled that federal funding of ESCR may continue while a legal challenge is considered.

D.C. federal judge Royce Lamberth had halted the grants Aug. 23 because a lawsuit against NIH guidelines on ESCR had “a strong likelihood” of succeeding. He has not issued a final ruling the case.

In his injunction stopping funding of ESCR, Lamberth found NIH’s 2009 guidelines violated a 1996 law that prohibits federal funds for research in which a human embryo is destroyed. NIH’s rules allow funding for research on stem cells derived from embryos created by in vitro fertilization but not implanted.
Tom Strode is the Washington bureau chief for Baptist Press.