In a blog item written yesterday by Don Gibbons, senior
science and education officer at the agency, the agency said that the practices described in the article generated a cautionary advisory to patients last month by the stem cell agency and 12 other organizations.
Gibbons noted that much of the Sept. 9 Times article by Laura Beil focused on one clinic, the Regenerative Medicine Institute in Tijuana, which is just on the California-Mexico border. Gibbons’ item reported that one U.S. expert says that some of the clinic’s key procedures would not pass muster in this country.
Gibbons noted that much of the Sept. 9 Times article by Laura Beil focused on one clinic, the Regenerative Medicine Institute in Tijuana, which is just on the California-Mexico border. Gibbons’ item reported that one U.S. expert says that some of the clinic’s key procedures would not pass muster in this country.
Gibbons continued,
The Times article quoted UC Davis researcher Paul Knoepfler as saying,“Most important, the clinic has not produced any publishable data. We all have great hope for the promise of stem cell science, but I think it is fair to say that anyone who legitimately cares about that promise wants to find out what is the right type of cell to put in each patient. When is the right time for the transplant, and what is the best method of delivering the cells. We will never learn those things without collecting data in a well-designed clinical trial and sharing that data.”
Gibbons also said that the International Society for Stem Cell Research, which backed away under threats of lawsuits a few years ago from some criticism of dubious stem cell clinics, plans to release this week a new statement on these sorts of treatments.“There is absolutely no legitimate reason for such clinics to be not publishing their data.”
We should note that
Times article, which is syndicated to many newspapers in this country, did not pick
up the widely reported instances of deaths and injuries from these treatments. It
did report that problems exist in this country as well as abroad. The article
said,
“In the United States, too, it is easy to conduct business outside government oversight, said Dr. George Q. Daley, who studies stem cells for blood diseases at Harvard Medical School. Close down one shady operation, he went on, and more seem to randomly pop up.
“Even questionable publicity does not necessarily hurt business. Regnocyte, a company in Florida, posted an unflattering CNN report about it on its Web site under the heading ‘special coverage.’”
Thank you for your September 11th blog on this most important issue. We share CIRM's position on questionable stem cell clinics and treatment practices that don't safeguard, first and foremost, the patient. Stemedica was proactive in supporting Laura Beil's investigative article in the New York Times because we believe it is fundamental that all human application of stem cells be conducted under Internationally recognized standards. As a company whose products are being used in two COFEPRIS-approved clinical trials in Mexico, we urge all stem cell therapies conducted there - and anywhere in the world - meet a similar, basic criteria as outline in the CIRM blog. The Industry's future rests on patient safety; regulatory compliance; properly manufactured products; treatment transparency; tracking of patients; and, the professional collection and reporting of results.
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