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

NCT00117936 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: CVBT-CHD07-01
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Disease; Coronary Heart Disease; Myocardial Ischemia; Coronary Arteriosclerosis

Keywords

Angiogenesis; No-option heart patients; Blocked coronary artery; Revascularization; FGF-1; growth factor

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• Change in CCS angina score

  Change in CCS angina score

  baseline to 12 weeks, followed up to one year

Secondary 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)

  1 year

Study Arms (3)

1

EXPERIMENTAL

Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - high dose, given as intramyocardial injections via a NOGA Injection Catheter, single cath lab session.

Combination Product: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose

2

EXPERIMENTAL

Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose, given as intramyocardial injections via a NOGA Injection Catheter, single cath lab session.

Combination Product: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose

3

PLACEBO COMPARATOR

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.

Combination Product: Placebo

Interventions

Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose COMBINATION_PRODUCT

Up to ten intramyocardial injections of low dose FGF 1-141, via a NOGA Injection Catheter, single cath lab session

1

Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose COMBINATION_PRODUCT

Up to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session

2

Placebo COMBINATION_PRODUCT

Up to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session

3

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Pattern of CHD (coronary pathology) where percutaneous interventional therapy and/or CABG is not recommended by the treating cardiologist. This decision should have a documented basis in either complicated vessel physiology and/or lack of suitable target vessels for both PTCA and CABG, or past history of complications.
• One/two/three vessel disease as evidenced either by an angiographic documentation of advanced atherosclerotic narrowing of ≥60% of at least one major epicardial coronary artery (right coronary artery \[RCA\], left circumflex \[LCX\], or LAD \[or any of their branches\]), or of diffuse type of CHD as evidenced by the appearance on coronary angiography of multiple stenoses, multiple atherosclerotic plaques, and/or peripheral occlusion(s) of coronary vessel(s) with and without a history of MIs.
• demonstrate a radionuclide or angiographically determined left ventricular ejection fraction (LVEF) ≥30%.
• Pre-operative proof of reversible ischemia.
• No evidence of proliferative retinopathy or significant non-proliferative retinopathy.
• must be on optimal medical therapy for at least 2 months prior to entering the study, as documented by a medical history. This will include medical management, and subjects must enter the study on at least one of the following medications: beta-blockers, calcium entry blockers, ranolizine, or long-acting nitrates.
• Exercise duration during the qualifying treadmill tests at Visit 1 and Visit 2 is ≥3 and ≤9 minutes on a modified Bruce protocol.
• Exercise durations for the qualifying treadmill tests at Visits 1 and 2 must satisfy at least one of the two following conditions: (a) they differ by less than or equal to 20% of the longer time; (b) they differ by less than or equal to 60 seconds. Subjects whose ETTs at Visits 1 and 2 do not satisfy at least one of these two conditions are allowed a third ETT, at the investigator's discretion, from 5 to 7 days after Visit 2. If a third ETT is done, then when compared with the second ETT it must satisfy at least one of the two conditions above.
• A forced vital capacity (FVC) of ≥30%.
• A negative pregnancy test in women of childbearing potential at Screening.
• Female subjects must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, has no intention to become pregnant during the course of the study, and is using contraceptive drugs or devices.
• Negative cancer screening tests according to the American Cancer Society (\[ACS\] Appendix 13.8).

You may not qualify if:

• 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.
• Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography.
• Creatine kinase (CK) levels \>3 x upper limit of normal (ULN).
• Renal insufficiency requiring dialysis or laboratory evidence of a serum creatinine \>2.0 mg/dL.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 x ULN.
• History of coagulation disorders or abnormal prothrombin time (PT) or partial thromboplastin time (PTT) \>1.5 x ULN, thrombocytopenia (\<100,000/µl), or ongoing anticoagulant therapy (with the exception of aspirin, up to 85 mg/day).
• History of blood cell diseases.
• Poorly controlled insulin-dependent diabetes mellitus (HbA1c \>8%)
• Pre-existing retinal disease, including proliferative retinopathy, severe nonproliferative retinopathy.
• Use of any illicit recreational drugs within the past year.
• A positive test result for human immunodeficiency virus (HIV) antibody.
• Screening ECG results demonstrating recent evidence of transmural ischemia.

Sponsors & Collaborators

• CardioVascular BioTherapeutics, Inc.: lead

Related Links

• web site of sponsor

MeSH Terms

Conditions

Coronary Disease; Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Emerson Perin, MD, PhD

  Texas Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren Sherman, MD

CONTACT

(972) 681-9368; wsherman@cvbt.com

Adam Nedella

CONTACT

(972) 681-9368; anedella@cvbt.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 11, 2005
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: November 1, 2019

Record last verified: 2019-10