Document Detail


Clinical trials in stem cell therapy: pitfalls and lessons for the future.
MedLine Citation:
PMID:  17230223     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The first human trial of stem cell therapy for cardiovascular disease was performed 4 years ago. Since that time, almost a dozen studies have reported the early and late clinical effects of cell therapy in acute myocardial infarction and chronic ischemic cardiomyopathy. Initial nonrandomized trials universally showed slight improvement in the left ventricular ejection fraction. Later randomized, controlled trials, however, suggested a less significant effect. They showed either no difference between cell therapy and control treatment or a slight treatment benefit with cell therapy that is lost by 12 months' follow-up. These results have dampened the enthusiasm of some members of the scientific community for the continuation of clinical trials. Because early phase I trials should not be judged on issues other than safety, however, research is unlikely to be hindered. Indeed, the clinical studies reported so far have already taught us a lot about the biology of myocardial repair. Achieving clinical success will, however, probably require much more investment in basic and experimental research. Here, we address some of the current pitfalls in clinical cell therapy trials and lessons that should be learned as we face the challenges of the future.
Authors:
Pat Metharom; Brendan Doyle; Noel M Caplice
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Nature clinical practice. Cardiovascular medicine     Volume:  4 Suppl 1     ISSN:  1743-4300     ISO Abbreviation:  -     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2007-01-18     Completed Date:  2007-04-06     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  101226507     Medline TA:  Nat Clin Pract Cardiovasc Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  S96-9     Citation Subset:  IM    
Affiliation:
Center for Research in Vascular Biology, Cork, Ireland.
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MeSH Terms
Descriptor/Qualifier:
Cardiomyopathies / therapy
Cardiovascular Diseases / therapy*
Clinical Trials as Topic*
Humans
Myocardial Infarction / therapy
Myocardial Ischemia / therapy
Stem Cell Transplantation*

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