Published Online: November 14, 2011. doi:10.1001/jama.2011.1670
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: Traverse, Henry, Pepine, Willerson, Forder, Hatzopoulos, Penn, Lambert, Vaughan, Simpson, Taylor, Olson, Handberg, Baraniuk, Loghin, Aguilar, Sayre, Vojvodic, Skarlatos, Gordon, Kwak, Moyé, Simari.
Acquisition of data: Traverse, Henry, Pepine, Willerson, Zhao, Forder, Byrne, Penn, Perin, Baran, Chambers, Lambert, Raveendran, Simon, Taylor, Cogle, Silva, Jorgenson, Olson, Bowman, Francescon, Geither, Handberg, Smith, Piller, Loghin, Zierold, Moyé.
Analysis and interpretation of data: Traverse, Henry, Ellis, Pepine, Willerson, Zhao, Forder, Penn, Lambert, Raveendran, Simpson, Gee, Taylor, Cogle, Thomas, Baraniuk, Richman, Zierold, Bettencourt, Gordon, Ebert, Kwak, Moyé, Simari.
Drafting of the manuscript: Traverse, Henry, Ellis, Willerson, Forder, Penn, Simpson, Silva, Bowman, Francescon, Geither, Smith, Skarlatos, Ebert, Moyé, Simari.
Critical revision of the manuscript for important intellectual content: Traverse, Henry, Pepine, Willerson, Zhao, Forder, Byrne, Hatzopoulos, Perin, Baran, Chambers, Lambert, Raveendran, Simon, Vaughan, Simpson, Gee, Taylor, Cogle, Thomas, Jorgenson, Olson, Handberg, Baraniuk, Piller, Loghin, Aguilar, Richman, Zierold, Bettencourt, Sayre, Vojvodic, Gordon, Kwak, Moyé, Simari.
Statistical analysis: Traverse, Forder, Simpson, Baraniuk, Moyé.
Obtained funding: Traverse, Henry, Pepine, Willerson, Hatzopoulos, Lambert, Simpson, Taylor, Thomas, Piller, Moyé, Simari.
Administrative, technical, or material support: Traverse, Pepine, Forder, Byrne, Penn, Baran, Raveendran, Simon, Simpson, Gee, Thomas, Jorgenson, Olson, Geither, Piller, Aguilar, Richman, Bettencourt, Sayre, Vojvodic, Gordon, Ebert, Moyé, Simari.
Study supervision: Traverse, Henry, Penn, Chambers, Lambert, Raveendran, Vaughan, Simpson, Taylor, Loghin, Skarlatos, Kwak, Simari.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Dr Penn reported being a consultant for Juventas Therapeutics and Aastrom Biosciences and receiving grant funding for his institution from Athersys. No other authors reported any financial disclosures.
Funding/Support: This study was supported by the National Heart, Lung, and Blood Institute (NHLBI) under the cooperative agreement 5 U01 HL087318-04 and in part by the NHLBI contracts N01-HB-37164 and HHSN268201000008C to the Molecular and Cellular Therapeutics Facility, University of Minnesota, and N01-HB-37163 and HHSN268201000007C to the Cell Processing Facility, Baylor College of Medicine.
Role of the Sponsor: The NHLBI as the funding sponsor contributed to the design and conduct of the study, as well as the review and approval of the manuscript. The NHLBI was minimally involved in the collection, analysis, and interpretation of the data, as well as in the preparation of the manuscript.
NHLBI Project Office Team: Sonia Skarlatos, PhD; David Gordon, MD, PhD; Wendy Taddei-Peters, PhD; Ray Ebert, PhD; Minjung Kwak, PhD; Beckie Chamberlin.
CCTRN Steering Committee Chair: Robert Simari, MD.
LateTIME Trial Investigators and Clinical Teams:Minneapolis Heart Institute Foundation: Timothy Henry, MD; Jay Traverse, MD; David McKenna, MD; Beth Jorgenson, RN; 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; 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; Lynette Westbrook, RN, MS; University of Florida Department of Medicine: Carl Pepine, MD; Barry Byrne, MD, PhD; Chris Cogle, MD; John Wingard, MD; Eileen Handberg, PhD; Tempa Curry, RN; Diann Fisk, MT; Vanderbilt University School of Medicine: David Zhao, MD; Antonis Hatzopoulos, PhD; Allen Naftilan, MD; Sherry Bowman, RN; Judy Francescon, RN; Karen Prater; St. Paul Heart Clinic, United Hospital: Ken Baran, MD; Jody LaRock, RN; Metro Cardiology, Mercy Hospital: Jeffrey Chambers, MD; Klaudija Dragicevic, RN; University of Minnesota: Ganesh Raveendran, MD; Barb Bruhn-Ding, RN; Emily Caldwell, RN; University Hospitals Case Medical Center: Daniel Simon, MD; Marco Costa, MD; Stacey Mazzurco, RN; Pepin Heart Institute, Florida Hospital Tampa: Charles Lambert, MD, PhD; Elizabeth Szymanski, RN; Michael E. DeBakey Medical Center: Biswajit Kar, MD.
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; Michelle Cohen; Baylor College of Medicine: Adrian Gee, PhD; Sara Richman; David Aguilar, MD; University of Texas Medical School: Catalin Loghin, MD; University of Florida Department of Medicine: John Forder, PhD (MRI Core Laboratory); Christopher R. Cogle, MD; Elizabeth Wise (Biorepository Core-Florida); Cleveland Clinic C5 Research Imaging Core: James Thomas, MD; Allen Borowski; Annitta Flinn; Cathy McDowell (Echo Core Laboratory); Center for Cardiovascular Repair: Doris Taylor, PhD; Claudia Zierold, PhD; Marjorie Carlson (Biorepository Core-Minnesota).
Online-Only Material: The author interview is available here.
Additional Contributions: The Cardiovascular Cell Therapy Research Network acknowledges its industry partners, Biosafe and Boston Scientific Corporation, for contributions of equipment and technical support during the conduct of the trial. We thank the NHLBI gene and cell therapies data and safety monitoring board and the NHLBI protocol review committee for their review and guidance of the LateTIME trial.