Stem cell therapy trials: a call for standardization.
There are currently 25 new clinical cellular therapy trials in progress for cardiovascular disease in the US, and a similar number ongoing in Europe. The lack of standardization in cell isolation, preparation, storage, and time and localization of delivery, present clear hurdles to this growing field. This emphasizes the need for an organized task force to work closely with the FDA to agree upon standardized methods with the end result being improvements in patient care and enhanced knowledge in the field.
Miller
Leslie W
LW
Cardiology, Washington Hospital Center, 110 Irving Street, NW, Room 1E-11, Washington, DC 20010, USA. leslie.w.miller@medstar.net
D002309:Cardiology / Q000379:methods*; D002986:Clinical Trials as Topic / Q000592:standards*; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D012015:Reference Standards; D033581:Stem Cell Transplantation; D014481:United States; D014486:United States Food and Drug Administration