Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25-75
SponsorVenturis Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sign an informed consent form.
Age ≥25 and ≤75 years, either gender, and any race.
At least a 3 month history of chronic, stable angina and is relieved by rest and/or nitroglycerin.
Documented symptomatic CCS Angina Classification of III to IV despite use of optimal medical therapy as noted in Inclusion Criterion 10.
Disqualifiers
History of undergoing a CABG, PTCA or TMR or evidence of an acute MI in the last 3 months.
Subjects with malignancies or a history of malignancies (with the exception of basal cell carcinoma [BCC] of the skin) will be excluded from the study. Those subjects with a history of BCC are eligible for enrollment, and will be monitored by a qualified dermatologist every 8 weeks for a period of 6 months for evaluation of their skin condition. Subjects with existing BCC will be excluded from the study.
Evidence of concurrent clinically significant infection (e.g. elevated white blood cell [WBC] count >13,000 x 109/L, temperature >38.5°C), evidence of "common cold" or "flu."
Concomitant other structural heart disease, such as moderate to severe heart valve disease, congenital heart disease, etc. other than evidence of congestive heart failure that is directly related to past ischemic events.
Trial design
Design model
Single group
Treatments tested in this trial
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose
Combination productUp to ten intramyocardial injections of low dose FGF 1-141, via a NOGA Injection Catheter, single cath lab session
Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose
Combination productUp to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session
Placebo
Combination productUp to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: 1Experimental treatment 1 intervention
Group B: 2Experimental treatment 1 intervention
Group C: 3Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 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
Time frame
1 year2
Change in CCS angina score
Change in CCS angina score
Time frame
baseline to 12 weeks, followed up to one yearSecondary outcomes
1
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)
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)
Time frame
1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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