–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA…
Dissecting The Press Release For A Failed Stem Cell Trial
May 18, 2017 by 5 Comments
–Stem cell therapy supporters can’t acknowledge that it might not work. Stem cells have never been shown to have any clinical benefit in patients with heart disease. But there is mounting anecdotal evidence that they may have serious adverse effects on the reasoning and objectivity of the medical researchers, biotechnology executives and investors who get…
Embattled Stem Cell Researchers Sue Harvard And Brigham And Women’s Hospital
December 17, 2014 by Leave a Comment
Two embattled and highly controversial stem cell researchers are suing the Brigham and Women’s Hospital and Harvard Medical School for an ongoing investigation into their research. The investigation has already resulted in the retraction of one paper in Circulation and an expression of concern about another paper in the Lancet. The suit was filed by Piero Anversa, the highly prominent…
Principal Investigator Of Suspended Cytori Stem Cell Trials Remains Hopeful
August 6, 2014 by Leave a Comment
Shares of Cytori Therapeutics took a big bit hit today after the company disclosed in a press release that it had suspended enrollment in its ATHENA and ATHENA II trials. This kind of news is never a good sign, but the principal investigator of the trial tells me that he believes the current problems are surmountable and that the trials are still…
Stem Cell Therapy To Fix The Heart: A House Of Cards About To Fall?
April 28, 2014 by 1 Comment
For more than a decade cardiac stem cell therapy has attracted an enormous amount of attention, promise, and research dollars. Now an original and important new study published in BMJ finds that many of the most promising results in the field are illusory and that the potential benefits of stem cells to treat heart disease are probably far…
Lancet Editors Raise More Questions About Prominent Harvard Stem Cell Researcher
April 11, 2014 by Leave a Comment
There’s more trouble for Piero Anversa, the prominent and controversial stem cell researcher. Today the Lancet issued an expression of concern about an influential, much-cited stem cell paper. As first reported by Retraction Watch, an investigation at Harvard Medical School and Brigham and Women’s Hospital has raised concerns about the integrity of data coming from Piero Anversa’s laboratory at the Brigham…
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