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Human Exceptionalism

Life and dignity with Wesley J. Smith.

Non Embryonic Pluripotent Stem Cell Human Trial Soon?



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Advanced Cell Technology claims it will soon apply to the FDA to conduct a human trial using induced pluripotent stem cells, that is, stem cells created from normal skin or other somatic cells.  From the Wall Street Journal story:

A Massachusetts biotechnology company said it expects as early as Friday to start the process for regulatory approval of what experts said would be the first human trial involving stem cells created by reprogramming adult cells back to an embryonic-like state. Researchers have been experimenting with treatments derived from stem cells, which can grow into other cell types or tissues. But such cells are typically obtained by destroying human embryos, a controversial practice…The newer approach involves reprogramming mature cells, typically from the skin, without the need to destroy embryos. Two of the researchers who developed the process shared a Nobel Prize this year for the work.

Advanced Cell Technology Inc. of Marlborough, Mass., says it wants to test blood-clotting particles, called platelets, made from such reprogrammed cells. People with certain forms of leukemia, anemia and other conditions need repeat infusions of platelets to avoid bleeding to death, but can develop resistance to the donated cells over time, making them less effective, experts say. Stem-cell derived platelets could overcome that problem because they could be derived from a patient’s own cells. “This would really be a dramatic advance in medicine, but it remains to be seen if this would be successful,” said Alan Michelson, a platelet researcher at Harvard Medical School and Boston Children’s Hospital who would lead a clinical trial in the U.S. studying ACT’s stem-cell derived platelets.

ACT is also running one of the three ongoing tiny human safety trials on embryonic stem cells for a degenerative eye disease.

I hope this will work out, but a big word of caution here. ACT is notorious (my belief) for hyping itself with claims of great pending research successes–I suspect, in the hope of gaining investments–that in the end, just don’t work out. For example, during Bush years, ACT PR geniuses generated story, after story, after story in notable publications. like The Atlantic, touting its supposedly accomplished or soon-co-come human cloning successes. It never happened. But ACT’s PR engine never stops.

Also note: Pluripotent stem cells–whether embryonic or induced–can cause tumors, and thus are usually not appropriate for human treatments.  Indeed, I am reminded of Geron Corporation, which was similarly able to generate repeated stories in the fawning press about embryonic stem cell trials likely to begin “next year.”  It finally happened–after about 5 years of promises.  Geron has since ended the trial and gone out of the stem cell research business.

So, I wish ACT success in the hope that IPSCs can work out in creating human treatments.  (They already are being used to create tailor made, disease-specific cell lines for use in drug testing and research.)  But in the old Ronald Reagan term, when it comes to ACT, always trust but verify. Strike that: Just verify.

Post Script: In the middle of the text I quoted, I skipped over the story that denigrates the value of adult stem cell in treating diseases. As readers of HE know, adult stem cell research has been tremendously successful, to the point that there are currently thousands of very hopeful human efficacy and safety trials ongoing. Typical media ignorance.



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