Published Online: November 18, 2013. doi:10.1001/jama.2013.282674.
Study concept and design: Traverse, Henry, Willerson, Ellis.
Acquisition of data: Traverse, Henry, Pepine, Willerson.
Analysis and interpretation of data: Traverse, Henry, Willerson.
Drafting of the manuscript: Traverse, Henry, Willerson.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Traverse, Willerson.
Obtained funding: Traverse, Pepine, Willerson.
Administrative, technical, or material support: Pepine, Willerson.
Study supervision: Traverse, Ellis.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Henry reported serving as a consultant for Capricor and Johnson & Johnson; and receiving grant support from Capricor and OSIRIS. Dr Pepine reported receiving funding for writing assistance, medicine, equipment, or administrative support from the National Heart, Lung, and Blood Institute, BDS Cordis Corp, and Biosafe; and receiving several institutional grants from several pharmaceutical companies and government institutions. Dr Willerson reported receiving funding from the National Heart, Lung, and Blood Institute for participation in review activities. Dr Ellis reported receiving travel support from Abbott Vascular and Boston Scientific. No other disclosures were reported.
Funding/Support: Funding for this trial was provided by the National Heart, Lung, and Blood Institute under cooperative agreement 5 UO1 HL087318-04. Support for cell processing (Sepax) was provided by Biosafe SA Inc. Angioplasty catheters were provided by Boston Scientific Corporation.
Role of the Sponsor: The National Heart, Lung, and Blood Institute had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We acknowledge all the contributions by the Investigators of the Cardiovascular Cell Therapy Research Network and the leadership and vision of the late Sonia Skarlatos, PhD (formerly with the National Heart, Lung, and Blood Institute).
Trial Registration: clinicaltrials.gov Identifier: NCT00684021