Published Online: November 6, 2012. doi:10.1001/jama.2012.25321
Author Contributions:Dr Hare 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: Hare, Gerstenblith, DiFede Velazquez, George, Mendizabal, McNiece, Heldman.
Acquisition of data: Hare, Fishman, Gerstenblith, DiFede Velazquez, Zambrano, Suncion, Tracy, Johnston, Brinker, Breton, Davis-Sproul, Byrnes, George, Lardo, Mendizabal, Lowery, Wong Po Foo, Ruiz, Amador, Da Silva, McNiece, Heldman.
Analysis and interpretation of data: Hare, Fishman, Zambrano, Suncion, Tracy, Ghersin, Lardo, Schulman, Mendizabal, Altman, Ruiz, Amador, Da Silva, McNiece, Heldman.
Drafting of the manuscript: Hare, Fishman, Ghersin, Mendizabal, Ruiz, Amador, Heldman.
Critical revision of the manuscript for important intellectual content: Hare, Fishman, Gerstenblith, DiFede Velazquez, Suncion, Tracy, Johnston, Brinker, Breton, Davis-Sproul, Schulman, Byrnes, Geroge, Lardo, Mendizabal, Lowery, Rouy, Altman, Wong Po Foo, Ruiz, Da Silva, McNiece, Heldman.
Statistical analysis: Hare, Mendizabal, McNiece, Heldman.
Obtained funding: Hare, Lardo.
Administrative, technical, or material support: Hare, DiFede Velazquez, Zambrano, Suncion, Ghersin, Johnston, Breton, Davis-Sproul, Schulman, Byrnes, Lowery, Rouy, Altman, Wong Po Foo, Da Silva, McNiece, Heldman.
Study supervision: Hare, Fishman, Gerstenblith, Tracy, George, Schulman, Altman, Da Silva, McNiece, Heldman.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Hare reported having a patent for cardiac cell-based therapy, receiving research support from and being a board member of Biocardia, having equity interest in Vestion Inc, and being a consultant for Kardia. Dr George reported serving on the board of GE Healthcare, consulting for ICON Medical Imaging, and receiving trademark royalties for fluoroperfusion imaging. Mr Mendizabal is an employee of EMMES Corporation. Drs Rouy, Altman, and Wong Po Foo are employees of Biocardia Inc. Dr McNiece reported being a consultant and board member of Proteonomix Inc. Dr Heldman reported having a patent for cardiac cell-based therapy, receiving research support from and being a board member of Biocardia, and having equity interest in Vestion Inc. No other authors reported any financial disclosures.
Funding/Support: This study was funded by the US National Heart, Lung, and Blood Institute (NHLBI) as part of the Specialized Centers for Cell-Based Therapy U54 grant (U54HL081028-01). Dr Hare is also supported by National Institutes of Health (NIH) grants RO1 HL094849, P20 HL101443, RO1 HL084275, RO1 HL107110, RO1 HL110737, and UM1HL113460. The NHLBI provided oversight of the clinical trial through the independent Gene and Cell Therapy Data and Safety Monitoring Board (DSMB). Biocardia Inc provided the Helical Infusion Catheters for the conduct of POSEIDON.
Role of the Sponsors: The NHLBI, NIH, and Biocardia Inc had no role in the design and conduct of the study; in the collection, management, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Additional Contributions: We thank the NHLBI Gene and Cell Therapy DSMB, the patients who participated in this trial, the bone marrow donors, the staff of the cardiac catheterization laboratories at the University of Miami Hospital and The Johns Hopkins Hospital. Erica Anderson, MA (EMMES Corporation), provided data management and Hongwei Tang, MD (TeraRecon Inc), provided consultation regarding CT imaging analysis. Ms Anderson received compensation for her contribution via the Specialized Centers for Cell-Based Therapy grant. Dr Tang did not receive any compensation for his contribution.
This article was corrected for errors on July 19, 2013.