stem cell clinical trial

Groundbreaking Organoid Vision Clinical Study: Takahashi Q&A

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Clinical trials using organoids are still rare and a Clinicaltrials.gov search for such organoid work largely brings up in vitro studies. A new clinical study in Japan where organoid material will actually be transplanted into patients is causing a lot of excitement. Masayo Takahashi (高橋 政代) is a pioneer in stem cell-based clinical trial work …

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FDA warns Northwestern’s Richard Burt on reporting patient deaths, other issues in stem cell trials

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The FDA recently issued a lengthy warning letter to Northwestern University over the clinical trial practices of its Dr. Richard Burt and this letter just popped up on the FDA website. To my knowledge this is an unprecedented event as I’m not aware of another warning letter to a major university for a stem cell trial. Burt received the FDA …

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Early, but encouraging data from Asterias on stem cells for spinal cord injury

Asterias

As I posted recently, Asterias Biotherapeutics has had good early safety results so far in its historic stem cell trial for spinal cord injury and now the company presented some early, encouraging hints at efficacy.  However, a caveat here is that this is not an RCT (randomized controlled trial). Ed Wirth, CMO of Asterias, presented the …

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End of line for StemCells Inc., pioneering & controversial stem cell biotech

stemcellsinc-logo

A sad, but not surprising day for the stem cell field as the biotech StemCells, Inc. announced that it is winding down its operations after terminating its spinal cord injury trial called the Pathway Study. The data generated so far did not justify continuing the trial. StemCells, Inc. (stock symbol STEM) has struggled financially for …

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Huge clinical trial patient fees allowed by FDA at times, details often secret

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I am often critical of for-profit stem cell clinics on this blog for numerous reasons. For instance, one thing that concerns me greatly about these clinics is that they charge patients to get experimental “treatments” that have not been proven to be safe or effective. But as some patients have pointed out to me over the …

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Cons Outweigh Potential Pros to BPC Plan on Stem Cells & FDA

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There is considerable interest in FDA regulatory reform here in the U.S. for stem cell therapies. The goal is to get new treatments to patients faster, but is there a way to do that without sacrificing proven safety and efficacy? You need convincing data on both safety and efficacy or speed becomes dangerous. A group called …

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Insider Trends on Stem Cells to Look Out for at ISSCR 2015 Stockholm

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The annual ISSCR meeting has started in Stockholm. This is always a great annual meeting both for the science and for connecting with people including new friends and colleagues as well as old friends. Another element to the meeting is the insider conversations in the halls, restaurants, and bars that tell a behind the scenes …

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Maps of global stem cell clinical trial trends

Late in 2012 I did a piece on the global trends in stem cell clinical trial patterns. It is time for an update. Another look at stem cell clinical trials now (late Sept. 2013) based on the clinicaltrials.gov database shows an encouraging trend. Total Stem Cell Clinical Trials The total number of stem cell clinical …

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