A DP Challenge Compendium
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Scoring systems in the intensive care unit: A compendium
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Nevertheless, despite negative bias, hostility, and nihilism, on the one hand, and unfounded or outright fraudulent claims, on the other, the broad community of investigators dedicated to the development of cell-based therapies has continued its work toward developing safe treatments with proven clinical benefits. The field has moved gradually from small observational, nonrandomized studies to medium-size phase 2 trials and now, phase 3 studies. Because of the 21st Century Cures Act and the new Food and Drug Administration Regenerative Medicine Advanced Therapy designation, it is possible that cell therapy for heart disease could be approved in the United States on the near term horizon.
Although the efficacy of cell therapy in patients remains to be definitely demonstrated, the results obtained to date are encouraging and warrant serious investigation with rigorous, well-designed phase 3 clinical trials. It is important that these studies be conducted. The answer to the current uncertainty and to the apparently conflicting results of small, inconclusive, often nonrigorous clinical trials is not to stop clinical investigation; the way forward is to conduct large, rigorous trials that test the efficacy of cell-based therapies conclusively.
The current situation in cell therapy is reminiscent of that in thrombolysis for acute myocardial infarction in the late s and early s. The first trial of streptokinase was published in Two decades later, many studies had been published with conflicting results, so that the benefits of thrombolysis were unclear. It took 27 years to demonstrate the efficacy of a treatment which is now a cornerstone in the management of acute myocardial infarction.
The confusion of the late s and early s was not overcome by halting clinical research but by conducting a well-designed and conclusive clinical trial. The history of thrombolytic therapy for acute infarction and of many other therapies as well teaches a valuable lesson: patience, rigor, and reliance on objective evidence rather than personal prejudice are the key to move medicine forward.
Discard Studies Compendium
Although it is not possible to cover every single aspect of a field as large and complex as regenerative cardiology, we hope that this compendium will help the readers to keep abreast of recent developments and future directions in this fascinating journey to make cardiac repair a reality. The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. Home Circulation Research Vol. View PDF. Tools Add to favorites Download citations Track citations Permissions. Jump to. References 1. Human induced pluripotent stem cell—derived cardiomyocytes as models for cardiac channelopathies: a primer for non-electrophysiologists.
Circ Res. Link Google Scholar 2. RNA therapeutics in cardiovascular disease. Link Google Scholar 3.
A Compendium of Potential Biomarkers of Pancreatic Cancer
Bolli R, Ghafghazi S. Stem cells: cell therapy for cardiac repair: what is needed to move forward? Nat Rev Cardiol. Crossref Medline Google Scholar 4. Sanganalmath SK, Bolli R. Cell therapy for heart failure: a comprehensive overview of experimental and clinical studies, current challenges, and future directions. Link Google Scholar 5. Cardiac stem cell treatment in myocardial infarction: a systematic review and meta-analysis of preclinical studies. Link Google Scholar 6.
Impact of cell therapy on myocardial perfusion and cardiovascular outcomes in patients with angina refractory to medical therapy: a systematic review and meta-analysis. Link Google Scholar 7. The translational road less traveled. Link Google Scholar 8. Eur Heart J. Crossref Medline Google Scholar 9.