NCT00117936

Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease

Human Recombinant Fibroblast Growth Factor-1 (FGF-1), for the Treatment of Subjects With Severe Coronary Heart Disease, a Placebo Controlled, Double-blind, Dose-varying Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: CardioVascular BioTherapeutics, Inc. · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Biological Delivery Systems MyoStar injection and mapping catheters, to stimulate the growth of blood vessels around blocked coronary arteries.

Detailed description

Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.

Conditions

• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Coronary Arteriosclerosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose	Up to ten intramyocardial injections of low dose FGF 1-141, via a NOGA Injection Catheter, single cath lab session
COMBINATION_PRODUCT	Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose	Up to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session
COMBINATION_PRODUCT	Placebo	Up to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-03-01
• Completion: 2023-03-01
• First posted: 2005-07-11
• Last updated: 2019-11-01

Regulatory

• FDA-regulated drug study
• FDA-regulated device study