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

Phase 2

• Conditions: Coronary Disease; Coronary Heart Disease; Myocardial Ischemia; Coronary Arteriosclerosis
• Interventions: Combination Product: Placebo; Combination Product: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose; Combination Product: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose

• Registration Number: NCT00117936
• Lead Sponsor: CardioVascular BioTherapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-07
• Study First Posted: 2005-07-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01
• Study Start: 2020-03
• Primary Completion: 2022-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3	Placebo	Placebo solution void (not containing) Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141), given as intramyocardial injections via a NOGA Injection Catheter, single cath lab session.
1	Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose	Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - high dose, given as intramyocardial injections via a NOGA Injection Catheter, single cath lab session.
2	Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose	Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose, given as intramyocardial injections via a NOGA Injection Catheter, single cath lab session.

Primary Outcome Measures

Name	Time	Method
Change in cardiac perfusion as measured by cMRI scan under stress conditions and change in vascular bed density at the sites of injections as determined by angiography	1 year	Change in cardiac perfusion as measured by cMRI scan under stress conditions and change in vascular bed density at the sites of injections as determined by angiography
Change in CCS angina score	baseline to 12 weeks, followed up to one year	Change in CCS angina score

Secondary Outcome Measures

Name	Time	Method
Exercise treadmill test: time (or change in time) to onset of at least 1 mm additional horizontal or downsloping ST-segment depression, or time to ETT in the absence of at least 1 mm additional ST-segment depression due to pain (angina)	1 year	Exercise treadmill test: time (or change in time) to onset of at least 1 mm additional horizontal or downsloping ST-segment depression, or time to ETT in the absence of at least 1 mm additional ST-segment depression due to pain (angina)