Clinical trials in coronary angiogenesis: issues, problems, consensus: An expert panel summary.
The rapid development of angiogenic growth factor therapy for patients with advanced ischemic heart disease over the last 5 years offers hope of a new treatment strategy based on generation of new blood supply in the diseased heart. However, as the field of therapeutic coronary angiogenesis is maturing from basic and preclinical investigations to clinical trials, many new and presently unresolved issues are coming into focus. These include in-depth understanding of the biology of angiogenesis, selection of appropriate patient populations for clinical trials, choice of therapeutic end points and means of their assessment, choice of therapeutic strategy (gene versus protein delivery), route of administration, and the side effect profile. The present article presents a summary statement of a panel of experts actively working in the field, convened by the Angiogenesis Foundation and the Angiogenesis Research Center during the 72nd meeting of the American Heart Association to define and achieve a consensus on the challenges facing development of therapeutic angiogenesis for coronary disease.
Simons
M
M
Angiogenesis Research Center, BIDMC, Harvard Medical School, Boston, MA, USA. msimons@caregroup.harvard.edu
Bonow
R O
RO
Chronos
N A
NA
Cohen
D J
DJ
Giordano
F J
FJ
Hammond
H K
HK
Laham
R J
RJ
Li
W
W
Pike
M
M
Sellke
F W
FW
Stegmann
T J
TJ
Udelson
J E
JE
Rosengart
T K
TK
D043925:Angiogenesis Inducing Agents / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use; D000818:Animals; D002986:Clinical Trials as Topic; D017023:Coronary Angiography; D003331:Coronary Vessels; D016228:Endothelial Growth Factors / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use; D016222:Fibroblast Growth Factor 2 / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use; D015316:Genetic Therapy / Q000009:adverse effects; D006331:Heart Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008222:Lymphokines / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use; D008279:Magnetic Resonance Imaging; D018919:Neovascularization, Physiologic; D018579:Patient Selection; D014055:Tomography, Emission-Computed; D015899:Tomography, Emission-Computed, Single-Photon; D042461:Vascular Endothelial Growth Factor A; D042442:Vascular Endothelial Growth Factors
D043925:Angiogenesis Inducing Agents; D016228:Endothelial Growth Factors; D008222:Lymphokines; D042461:Vascular Endothelial Growth Factor A; D042442:Vascular Endothelial Growth Factors; D016222:Fibroblast Growth Factor 2