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Nature Biotechnology 27, 496–498 (1 June 2009) | doi:10.1038/nbt0609-496c

US regulator wades into stem cell therapies for heart disease

Randy Osborne

The US Food and Drug Administration's (FDA) draft guidance on cell therapy for cardiac disease has been given a muted welcome by clinicians and industry—not least because it may bolster the reputation of a field that thus far has enjoyed more than its fair share of charlatans and quacks. One impetus for the April release of the guidelines is problems cropping up with existing bone marrow–-derived cell therapies for heart disease in the clinic.