This Program Project Grant Application (PPG) is a revised version of a Proposal which we initially submitted in response to RFA HL-00-008 to seek funding for a Program of Excellence in Gene Therapy (PEGT) at St. Elizabeth's Medical Center (SEMC)/Tufts University School of Medicine (TUSM) with collaboration from the Cleveland Clinic Department of Surgery, and the Biostatistics Center, George Washington University, Rockville, Maryland. The PPG consists of three Clinical Projects and two Pre-clinical Projects, supported by four Cores. Dr. Jeffrey M. Isner, Principal Investigator (PI) with overall responsibility for the PPG, will serve as Project Director for (clinical) Project 1, """"""""VEGF Gene Transfer for Diabetic Neuropathy."""""""" Dr. Douglas Losordo will direct (clinical) Project 2, """"""""VEGF Gene Transfer to Prevent Coronary Artery Restenosis."""""""" (Clinical) Project 3, """"""""VEGF Gene Transfer to Promote Angiogenesis in Patients with Advance Heart Failure,"""""""" will be directed by Dr. Patrick McCarthy, Surgical Director of the Cleveland Clinic Kaufman Center for Heart Failure. Ken Walsh, Ph.D. will serve as Project Director for (pre-clinical) Project 4, """""""" Molecular Studies of Heart Failure."""""""" Dr. Takayuki Asahara will direct (pre-clinical) Project 5, """"""""Endothelial Progenitor Cell Gene Transfer."""""""" The research productivity and functional capacity of the PPG will be enhanced by four Cores. Core A, the Plasmid Core, will provide clinical grade plasmid DNA vector, and will be supervised by Dr. Walsh. Core B, the Administrative Core, directed by Dr. Losordo, will supply critical administrative assistance. Drs. Losordo and Walsh will also direct Core C, the Training Core. Core D, the Data Management Core, directed by Kathryn Hirst, Ph.D. Research Associate Professor of the Biostatistics Center, George Washington University will assist with data management and analysis, and will also ensure compliance with all appropriate regulatory bodies. The studies and organization outlined in this PPG are intended to provide high quality and credible clinical as well as pre-clinical research studies of gene transfer that will represent meaningful contributions to both the scientific community and lay public.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Program Projects (P01)
Project #
Application #
Study Section
Heart, Lung, and Blood Initial Review Group (HLBP)
Program Officer
Skarlatos, Sonia
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
St. Elizabeth's Medical Center of Boston
United States
Zip Code
Sekiguchi, Haruki; Ii, Masaaki; Jujo, Kentaro et al. (2013) Estradiol promotes neural stem cell differentiation into endothelial lineage and angiogenesis in injured peripheral nerve. Angiogenesis 16:45-58
Sekiguchi, Haruki; Ii, Masaaki; Jujo, Kentaro et al. (2012) Estradiol triggers sonic-hedgehog-induced angiogenesis during peripheral nerve regeneration by downregulating hedgehog-interacting protein. Lab Invest 92:532-42
Webber, Matthew J; Tongers, Jorn; Newcomb, Christina J et al. (2011) Supramolecular nanostructures that mimic VEGF as a strategy for ischemic tissue repair. Proc Natl Acad Sci U S A 108:13438-43
Roncalli, Jerome; Renault, Marie-Ange; Tongers, Jorn et al. (2011) Sonic hedgehog-induced functional recovery after myocardial infarction is enhanced by AMD3100-mediated progenitor-cell mobilization. J Am Coll Cardiol 57:2444-52
Ii, Masaaki; Takeshita, Kyosuke; Ibusuki, Kayoko et al. (2010) Notch signaling regulates endothelial progenitor cell activity during recovery from arterial injury in hypercholesterolemic mice. Circulation 121:1104-12
Webber, Matthew J; Tongers, Jörn; Renault, Marie-Ange et al. (2010) Development of bioactive peptide amphiphiles for therapeutic cell delivery. Acta Biomater 6:3-11
Gupta, Rajesh; Tongers, Jörn; Losordo, Douglas W (2009) Human studies of angiogenic gene therapy. Circ Res 105:724-36
Ii, Masaaki; Hoshiga, Masaaki; Negoro, Nobuyuki et al. (2009) Adrenal androgen dehydroepiandrosterone sulfate inhibits vascular remodeling following arterial injury. Atherosclerosis 206:77-85
Losordo, Douglas W; Kishore, Raj (2009) A big promise from the very small identification of circulating embryonic stem-like pluripotent cells in patients with acute myocardial infarction. J Am Coll Cardiol 53:10-2
Zhou, Junlan; Zhu, Yan; Cheng, Min et al. (2009) Regulation of vascular contractility and blood pressure by the E2F2 transcription factor. Circulation 120:1213-21

Showing the most recent 10 out of 29 publications