Published Online: March 24, 2012. doi:10.1001/jama.2012.418
Author Contributions: Dr Moyé had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Perin, Willerson, Pepine, Henry, Zhao, Silva, Lai, Thomas, Kronenberg, Traverse, Penn, Hatzopoulos, Westbrook, Handberg, Olson, Baraniuk, Piller, Simpson, Bettencourt, Sayre, Skarlatos, Gordon, Kwak, Moyé, Simari.
Acquisition of data: Perin, Willerson, Pepine, Henry, Zhao, Silva, Anderson, Traverse, Anwaruddin, Taylor, Cogle, Smith, Westbrook, Chen, Handberg, Olson, Geither, Bowman, Francescon, Piller, Zierold, Vojvodic, Moyé.
Analysis and interpretation of data: Perin, Willerson, Pepine, Henry, Ellis, Zhao, Silva, Lai, Thomas, Kronenberg, Martin, Penn, Hatzopoulos, Gee, Taylor, Cogle, Baraniuk, Piller, Simpson, Loghin, Aguilar, Richman, Zierold, Vojvodic, Gordon, Ebert, Kwak, Moyé, Simari.
Drafting of the manuscript: Perin, Willerson, Pepine, Ellis, Silva, Westbrook, Geither, Moyé, Simari.
Critical revision of the manuscript for important intellectual content: Perin, Willerson, Pepine, Henry, Zhao, Silva, Lai, Thomas, Kronenberg, Martin, Anderson, Traverse, Penn, Anwaruddin, Hatzopoulos, Gee, Taylor, Cogle, Smith, Westbrook, Chen, Handberg, Olson, Bowman, Francescon, Baraniuk, Piller, Simpson, Loghin, Aguilar, Richman, Zierold, Bettencourt, Sayre, Vojvodic, Skarlatos, Gordon, Ebert, Kwak, Moyé, Simari.
Statistical analysis: Lai, Thomas, Baraniuk, Vojvodic, Moyé.
Obtained funding: Willerson, Pepine, Penn, Hatzopoulos, Taylor, Handberg, Piller, Simpson.
Administrative, technical, or material support: Perin, Willerson, Pepine, Zhao, Thomas, Kronenberg, Martin, Anderson, Traverse, Smith, Westbrook, Chen, Handberg, Olson, Bowman, Francescon, Piller, Simpson, Aguilar, Bettencourt, Sayre, Vojvodic, Gordon, Ebert.
Study supervision: Willerson, Zhao, Thomas, Hatzopoulos, Simpson, Loghin, Skarlatos, Kwak, Simari.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. All of the authors reported receiving research grant funding and support for travel expenses to meetings for the Cardiovascular Cell Therapy Research Network (CCTRN) from the National Heart, Lung, and Blood Institute (NHLBI). Dr Perin reported serving as a consultant to Amorcyte, Teva, Cytori, and Aldagen. Dr Pepine reported receiving research grants from Amarin Pharma, Amorycyte, Angioblast/Mesoblast, Baxter Healthcare, Bayer Healthcare, Daiichi-Sankyo, GlaxoSmithKline, Lilly, Merck, the National Institutes of Health, the National Heart, Lung, and Blood Institute, Pfizer, sanofi-aventis, Viron Therapeutics; serving as a consultant to Aastrom, Amarin Pharma, Amorycyte (scientific advisory board), Angioblast Systems (data and safety monitoring board), Lilly and County Community Foundation (data and safety monitoring board), and SLACK Inc; and holding 2 patents with the University of Florida. Dr Henry reported serving on steering committees for and receiving research grants from Aastrom and Mesoblast. Dr Martin reported receiving research grants from the University of Texas to provide an exercise testing core laboratory and received financial support for travel expenses. Dr Penn reported receiving research grants from Athersys Inc; serving as a board member for Juventas Therapeutics; serving as a consultant to Juventas Therapeutics and Aastrom Biosciences; and holding patents, receiving royalties, and owning stock in Juventas Therapeutics. Dr Hatzopoulos reported receiving payment for lectures from Washington University, University of Minnesota, and Tennessee State University. Dr Taylor reported receiving payment for a lecture at an annual meeting of the Cell Society. Dr Handberg reported receiving grants from Baxter, BDI, Amrin, Angioblast, Neostem, Harvest Technologies, Daiichi Sankyo, Pfizer, Gilead Sciences, and GlaxoSmithKline. Ms Olson reported receiving research grants from Mesoblast and Aastrom. Ms Geither reported receiving support for travel expenses to meetings from the Cleveland Clinic. Dr Aguilar reported being a consultant to Amylin Pharmaceutical in the area of diabetes and heart failure.
Funding/Support: Funding for this trial was provided by the NHLBI under cooperative agreement 5 U01 HL087318-04. It also was supported in part by NHLBI contracts N01-HB-37164 and HHSN268201000008C awarded to the Molecular and Cellular Therapeutics Facility, University of Minnesota, and N01-HB-37163 and HHSN268201000007C awarded to the Cell Processing Facility, Baylor College of Medicine, and National Center for Research Resources CTSA grant UL1 TR000064 awarded to the University of Florida. The CCTRN also acknowledges its industry partners: Biosafe, Biologics Delivery Systems Group, and Cordis Corporation for their contributions of equipment and technical support during the conduct of the trial.
Role of the Sponsor: The NHLBI had a role in the design and conduct of the study; and had a minimal role in the collection, management, analysis, or interpretation of the data; and preparation, review, or approval of the manuscript.
NHLBI Project Office Team: Sonia Skarlatos, PhD, David Gordon, MD, PhD, Ray Ebert, PhD, Wendy Taddei-Peters, PhD, Minjung Kwak, PhD, and Beckie Chamberlin.
CCTRN Steering Committee Chair: Robert Simari, MD.
FOCUS Trial Investigators and Clinical Teams:Minneapolis Heart Institute Foundation: Timothy Henry, MD, Jay Traverse, MD, David McKenna, MD, Beth Jorgenson, RN, and Rachel Olson, RN, MS. Cleveland Clinic Foundation: Stephen Ellis, MD, Marc Penn, MD, PhD, Saif Anwaruddin, MD, James Harvey, MD, Carrie Geither, RN, Mark Jarosz, RN, Cindy Oblak, and Jane Reese Koc, MT. Texas Heart Institute: James Willerson, MD, Emerson Perin, MD, PhD, Guilherme Silva, MD, James Chen, RN, Casey Kappenman, Deirdre Smith, RN, and Lynette Westbrook, RN, MS. University of Florida Department of Medicine: Carl Pepine, MD, Barry Byrne, MD, Christopher Cogle, MD, David Anderson, MD, John Wingard, MD, Eileen Handberg, PhD, Tempa Curry, RN, and Diann Fisk, MT. Vanderbilt University School of Medicine: David Zhao, MD, Antonis Hatzopoulos, PhD, Allen Naftilan, MD, Sherry Bowman, RN, Judy Francescon, RN, and Karen Prater.
Data Coordinating Center and Laboratory Teams:University of Texas School of Public Health: Lemuel Moye, MD, PhD, Lara Simpson, PhD, Linda Piller, MD, MPH, Sarah Baraniuk, PhD, Dejian Lai, PhD, Shreela Sharma, PhD, Judy Bettencourt, MPH, Shelly Sayre, MPH, Rachel Vojvodic, MPH, Larry Cormier, Robert Brown, PhD, Diane Eady, Crystal Maitland, MBA, Courtney Ransom, Maybelle Sison, RN, and Michelle Cohen. Baylor College of Medicine: Adrian Gee, PhD, Sara Richman, and David Aguilar, MD. University of Texas Medical School: Catalin Loghin, MD. Cleveland Clinic C5 Research Imaging Core: James Thomas, MD, Allen Borowski, Annitta Flinn, and Cathy McDowell (echo core laboratory). Vanderbilt University School of Medicine: Marvin Kronenberg, MD, Doreen Judd, and Amy Wright (SPECT core laboratory). University of Florida Department of Physical Therapy: Daniel Martin, PhD, PT, Eileen Handberg, PhD (maximal oxygen consumption core laboratory). Center for Cardiovascular Repair: Doris Taylor, PhD, Claudia Zierold, PhD, and Marjorie Carlson (biorepository core in Minnesota). University of Florida Department of Medicine: Christopher R. Cogle, MD, and Elizabeth Wise (biorepository core in Florida).
Additional Contributions: We thank the NHLBI gene and cell therapies data and safety monitoring board and the protocol review committee for their review and guidance of the FOCUS trial and Rebecca A. Bartow, PhD, of the Texas Heart Institute at St Luke's Episcopal Hospital for editorial assistance. Dr Bartow was not financially compensated for her contribution.