Clinical trials of cell-based therapies

pathology

treatment

patient

Demonstrated benefit and harm

coronary artery disease

fibroblast growth factor

not classified

versus control or placebo

No demonstrated result for efficacy

meta-analysis

Trial	control	p<0.05	harm	NS
AGENT-1 (Grines), 2002	fibroblast growth factor gene vs placebo
AGENT-2 (Grines), 2003	fibroblast growth factor gene vs placebo
AGENT-3	fibroblast growth factor gene vs placebo
AGENT-4	fibroblast growth factor gene vs placebo
AWARE	fibroblast growth factor gene vs placebo
AGENT 3 and 4 pooled	fibroblast growth factor gene vs placebo
FIRST (Simons), 2002	fibroblast growth factor vs placebo

Trial	Treatments	Patients	Method
AGENT-1 (Grines), 2002	Ad5FGF-4 (replication deficient, E1A/E1Bdeleted, human adenovirus serotype 5 with human FGF-4 gene insert: alferminogene tadenovec (n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
AGENT-2 (Grines), 2003	Ad5FGF-4 (replication deficient, E1A/E1Bdeleted, human adenovirus serotype 5 with human FGF-4 gene insert: alferminogene tadenovec (n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
AGENT-3	Ad5FGF-4 (replication deficient, E1A/E1Bdeleted, human adenovirus serotype 5 with human FGF-4 gene insert: alferminogene tadenovec (n=-9) vs. placebo (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
AGENT-4	Ad5FGF-4 (replication deficient, E1A/E1Bdeleted, human adenovirus serotype 5 with human FGF-4 gene insert: alferminogene tadenovec (n=-9) vs. placebo (n=-9)		Sample size: -9/-9 Primary endpoint: Treadmill exercise duration FU duration:
AWARE	intracoronary infusion of Ad5FGF-4 (n=-9) vs. placebo (n=-9)	Female Patients With Stable Angina Pectoris Who Are Not Candidates for Revascularization	double blind Sample size: -9/-9 Primary endpoint: time to onset of ECG changes during ETT FU duration:
AGENT 3 and 4 pooled	Ad5FGF-4 (replication deficient, E1A/E1Bdeleted, human adenovirus serotype 5 with human FGF-4 gene insert: alferminogene tadenovec (n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
FIRST (Simons), 2002	Single-bolus intracoronary administration of fibroblast growth factor-2 (FGF2) (n=-9) vs. placebo (n=-9)	patients with coronary artery disease	double blind Sample size: -9/-9 Primary endpoint: FU duration: 90 days

coronary artery disease

gene therapy

not classified

versus control or placebo

No demonstrated result for efficacy

meta-analysis

cell-based therapies Description Results NMA

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cell-based therapies
Description Results NMA