Biomedical Engineering Reference
In-Depth Information
Table 5.2
The most relevant clinical trials in protein therapy
Trial
Phase
N (Treated/
Control)
Agent
Delivery
method
Patients
Outcomes
Shumacher
et al.1998[
71
]
I
20/20
FGF-1
IM
LAD coronary artery
anastomosis
: capillary network sprouting
No improved coronary perfusion or LV function
Laham
et al.2000[
46
]
I
52 (8CD)
FGF-2
IC
Stable angina pectoris
Improvement in exercise tolerance and ; infarct size
FIRST
Simons et al.
2002[
57
]
II
251 (3CD)/
86
FGF-2
IC
Coronary artery disease
No long-term symptoms improvement and no
improvement in myocardial perfusion
VIVA
Henry et al.
2003[
59
]
II
125 (2CD)/
63
VEGF-A
IV
Angina pectoris (no-option
for revascularization)
Safe and feasible; Significant improvement in angina but
no improvements in myocardial perfusion
THEANGIOGEN
II
Ongoing
(*20)
VEGF-165
IM
Patients with advanced
severe angina
Non provided
STEM-AMI
Achilli et al.
2010[
72
]
II
29/27
G-CSF
PC
Patients with STEMI
No significant differences in LVEF or perfusion between
groups
SITAGRAMI[
73
]
Theiss et al. 2010
III
50/50
G-CSF ?
Sitagliptine
PC
Acute myocardial infarction
patients
Safe and feasible
Gao
et al.2010[
74
]
IV
32 (3CD)/
11
NRG
IV
Cardiac heart failure patients
No significant improvement of cardiac function and anti-
remodeling effect
Voors
et al.2010[
75
]
II
263/266
EPO
IV
Patients with STEMI
No significant improvement of cardiac function
LVEF left ventricular ejection fraction; LV left ventricle; LAD left anterior descending; anterior STEMI ST-elevation myocardial infarction; IM intramy-
ocardial; IC intracoronary artery infusion; PC percutaneous; IV intravenous injection; CD cell doses
