Study Raises Troubling Questions About Stem Cell Trial Design

Image: Bone marrow stem cells: More work is needed to understand how the cells behave in the body.

Professor Harald Arnesen and colleagues from the Ullev?University Hospital, Oslo, Norway looked at studies published to date on the relatively new technique of using of autologous (derived or transferred from the same individual's body) stem cells derived from bone marrow cells to strengthen cardiac function. The authors refer to a trial done in 2002 in which the cells were administered into the heart with encouraging results. After reviewing the studies,
Professor Arnesen has called for a moratorium on the use of the stem cells to prevent heart attacks because he believes the design of the study that resulted in some apparently successful trials is flawed. Apparently, the outcome of the study that resulted in a conclusion that the treatment group showed improvement when compared with the control group could be explained by the control group doing particularly badly, with a six percent mortality:

"It is astonishing that it is driven by a very poor outcome in a placebo group. In the present setting this figure is unusually high, as is the incidence of reinfarctions also of 6 per cent reported in the placebo group in the Frankfurt study."

The team approached the company that made the substance that was injected into the heart as a control, instead of the stem cells. Prof Arnesen said: "We were really astonished to learn from the producer in Maryland, US, that this medium was never intended or accepted for use in humans at all."

"We are warning doctors about the dangers of introducing these protocols to thousands of new patients in large studies," he said. "We need more research."

Related:
Injecting Autologous Cells Could Relieve Urinary Incontinence
Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study

Posted July 2, 2007 10:41 PM