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After patient dies, Aastrom halts trial testing bone-marrow stem cells in heart disease

A patient death from unknown causes has led the company Aastrom to halt its clinical trial in which a mixed population of bone marrow cells is injected into patients’ heart muscle. The trial uses cells collected from the same patient who will receive the injection, and was examining the potential to treat heart failure caused by dilated cardiac myopathy.

Here is the press release from Aastrom. Here’s what's essentially a shortened version from Reuter’s.

There are a lot of trials using a patient’s own stem cells to treat heart disease; so far they don’t seem to do much benefit, but they don’t seem to cause harm either. See our 2008 feature, Stem cells for the heart, a new wave of clinical trials.

Aastrom’s is an unusual delivery method in injecting the cells right into the heart muscle, and it looked like it was gaining traction. See this report in the Times of India, which doesn’t mention Aastrom, but does refer to an affiliated scientist, Amit Patel. Patel gave the rosy update on Aastrom’s clinical trial on May 5th, a couple weeks before the death was announced. At that point, 13 of a desired total of 40 patients had been enrolled in the trial.

This year, there have been some positive results from Osiris and new approaches using sorted cells announced for using stem cells in heart failure.

Still, scientists have expressed strong doubts about whether bone-marrow derived cells will provide lasting benefits in heart failure. (See Q&A with Christine Mummery)

Posted by Monya Baker on May 22, 2009
Categories: Clinical trials | | Comments (1) | TrackBacks (0)

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Hi there,

My name is Steve Zoegall, and I handle media relations for Aastrom Biosciences. In response to Monya's 5/22/09 blog post on Aastrom, as of 6/18/09 the clinical hold has been removed and the trial has resumed enrollment at all sites. The URL above leads to the relevant press release.

Aastrom and the first patient treated in the trial are also the focus of a recent U.S. News & World Report article: http://health.usnews.com/articles/health/heart/2009/07/02/embryonic-stem-cells--and-other-stem-cells--promise-to-advance-treatments.html

Thanks very much!
Steve

Posted by: Stephen Zoegall | July 7, 2009 06:00 PM

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