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An analysis of clinical studies that use adult stem cells to treat heart disease has raised questions about the value of a therapy that many consider inappropriately hyped.
Early-phase clinical trials have reported that adult stem cells are effective in treating heart attack and heart failure, and many companies are moving quickly to tap into this potentially lucrative market. But a comprehensive study that looked at discrepancies in trials investigating treatments that use patients’ own stem cells, published this week in the journal BMJ (ref. 1), finds that only trials containing flaws, such as design or reporting errors, showed positive outcomes. Error-free trials showed no benefit at all.
The publication comes as two major clinical trials designed to conclusively test the treatment’s efficacy are recruiting thousands of patients.
The BMJ paper “is concerning because the therapeutic approach is already being commercialized”, argues stem-cell researcher Paolo Bianco at the Sapienza University of Rome. “Premature trials can create unrealistic hopes for patients, and divert resources from the necessary basic studies we need to design more appropriate treatments.”
Therapies that use adult...