Literature DB >> 24147517

Implementation of cardovascular cell therapy network trials: challenges, innovation and lessons learned from experience in the CCTRN.

Ki E Park1, Lemuel A Moyé, Timothy D Henry, Emerson C Perin, Shelly L Sayre, Judy Bettencourt, Rachel W Vojvodic, Rachel E Olson, Carl J Pepine.   

Abstract

The cardiovascular cell therapy network was developed by the National Heart, Lung and Blood Institute to design and conduct clinical trials to advance the field of cardiovascular (CV) cell-based therapy. The Cardiovascular Cell Therapy Network successfully completed three clinical trials involving approximately 300 subjects across five centers and six satellites. Although the concept of a network within clinical trials research is not new, the knowledge gained in the implementation of such large-scale trials, particularly in novel therapeutic areas such as cell therapy is not often detailed in the literature. The purpose of this communication is to summarize key factors in achieving network goals and share the knowledge gained to promote success in future cardiovascular disease cell therapy trials and networks.

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Year:  2013        PMID: 24147517      PMCID: PMC4117343          DOI: 10.1586/14779072.2013.839943

Source DB:  PubMed          Journal:  Expert Rev Cardiovasc Ther        ISSN: 1477-9072


  32 in total

1.  2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.

Authors:  Patrick T O'Gara; Frederick G Kushner; Deborah D Ascheim; Donald E Casey; Mina K Chung; James A de Lemos; Steven M Ettinger; James C Fang; Francis M Fesmire; Barry A Franklin; Christopher B Granger; Harlan M Krumholz; Jane A Linderbaum; David A Morrow; L Kristin Newby; Joseph P Ornato; Narith Ou; Martha J Radford; Jacqueline E Tamis-Holland; Jacqueline E Tommaso; Cynthia M Tracy; Y Joseph Woo; David X Zhao
Journal:  Circulation       Date:  2012-12-17       Impact factor: 29.690

Review 2.  Quantification of myocardial segmental function in acute and chronic ischemic heart disease and implications for cardiovascular cell therapy trials: a review from the NHLBI-Cardiovascular Cell Therapy Research Network.

Authors:  John W Petersen; John R Forder; James D Thomas; Lemuel A Moyé; Mark Lawson; Catalin Loghin; Jay H Traverse; Sarah Baraniuk; Guilherme Silva; Carl J Pepine
Journal:  JACC Cardiovasc Imaging       Date:  2011-06

3.  Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN).

Authors:  Robert D Simari; Lemuel A Moyé; Sonia I Skarlatos; Stephen G Ellis; David X M Zhao; James T Willerson; Timothy D Henry; Carl J Pepine
Journal:  J Cardiovasc Transl Res       Date:  2010-02       Impact factor: 4.132

4.  Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction.

Authors:  Volker Schächinger; Sandra Erbs; Albrecht Elsässer; Werner Haberbosch; Rainer Hambrecht; Hans Hölschermann; Jiangtao Yu; Roberto Corti; Detlef G Mathey; Christian W Hamm; Tim Süselbeck; Birgit Assmus; Torsten Tonn; Stefanie Dimmeler; Andreas M Zeiher
Journal:  N Engl J Med       Date:  2006-09-21       Impact factor: 91.245

5.  Full coverage for preventive medications after myocardial infarction.

Authors:  Niteesh K Choudhry; Jerry Avorn; Robert J Glynn; Elliott M Antman; Sebastian Schneeweiss; Michele Toscano; Lonny Reisman; Joaquim Fernandes; Claire Spettell; Joy L Lee; Raisa Levin; Troyen Brennan; William H Shrank
Journal:  N Engl J Med       Date:  2011-11-14       Impact factor: 91.245

6.  LateTIME: a phase-II, randomized, double-blinded, placebo-controlled, pilot trial evaluating the safety and effect of administration of bone marrow mononuclear cells 2 to 3 weeks after acute myocardial infarction.

Authors:  Jay H Traverse; Timothy D Henry; Douglas E Vaughan; Stephen G Ellis; Carl J Pepine; James T Willerson; David X M Zhao; Lara M Simpson; Marc S Penn; Barry J Byrne; Emerson C Perin; Adrian P Gee; Antonis K Hatzopoulos; David H McKenna; John R Forder; Doris A Taylor; Christopher R Cogle; Sarah Baraniuk; Rachel E Olson; Beth C Jorgenson; Shelly L Sayre; Rachel W Vojvodic; David J Gordon; Sonia I Skarlatos; Lemuel A Moyè; Robert D Simari
Journal:  Tex Heart Inst J       Date:  2010

7.  Population trends in the incidence and outcomes of acute myocardial infarction.

Authors:  Robert W Yeh; Stephen Sidney; Malini Chandra; Michael Sorel; Joseph V Selby; Alan S Go
Journal:  N Engl J Med       Date:  2010-06-10       Impact factor: 91.245

8.  Intracoronary bone marrow cell transfer after myocardial infarction: 5-year follow-up from the randomized-controlled BOOST trial.

Authors:  Gerd P Meyer; Kai C Wollert; Joachim Lotz; Jens Pirr; Ulrike Rager; Peter Lippolt; Andreas Hahn; Stephanie Fichtner; Arnd Schaefer; Lubomir Arseniev; Arnold Ganser; Helmut Drexler
Journal:  Eur Heart J       Date:  2009-12       Impact factor: 29.983

9.  Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction.

Authors:  Jay H Traverse; Timothy D Henry; Douglas E Vaughan; Douglas E Vaughn; Stephen G Ellis; Carl J Pepine; James T Willerson; David X M Zhao; Linda B Piller; Marc S Penn; Barry J Byrne; Emerson C Perin; Adrian P Gee; Antonis K Hatzopoulos; David H McKenna; John R Forder; Doris A Taylor; Christopher R Cogle; Rachel E Olson; Beth C Jorgenson; Shelly L Sayre; Rachel W Vojvodic; David J Gordon; Sonia I Skarlatos; Lemuel A Moye'; Robert D Simari
Journal:  Am Heart J       Date:  2009-07-23       Impact factor: 4.749

Review 10.  Autologous bone marrow stem cells to treat acute myocardial infarction: a systematic review.

Authors:  Enca Martin-Rendon; Susan J Brunskill; Chris J Hyde; Simon J Stanworth; Anthony Mathur; Suzanne M Watt
Journal:  Eur Heart J       Date:  2008-06-03       Impact factor: 29.983

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  1 in total

1.  Clinical research skills development program in cell-based regenerative medicine.

Authors:  Ivonne Hernandez Schulman; Viky Suncion; Vasileios Karantalis; Wayne Balkan; Joshua M Hare
Journal:  Stem Cells Transl Med       Date:  2014-12-29       Impact factor: 6.940

  1 in total

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