Coronary DiseasePhase 2NCT00117936
Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease
A Phase 2 study testing Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose and Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose in people with Coronary Disease and Coronary Heart Disease, run by Venturis Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Coronary Disease, Coronary Heart Disease, Myocardial Ischemia
- What is being tested?
- Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose and Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2027to 15 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
- For a treadmill test result to support inclusion it must terminate in the presence of angina for either of the following reasons: (a) angina becomes too severe to continue the test AND there must be a horizontal depression or downsloping ST-segment of at least 1 mm measured 80 ms from the J point as subsequently established by the Biomedical Systems central ECG lab, or (b) angina of any grade AND there must be a horizontal depression or downsloping ST-segment measured 80 ms from the J point of 2 mm during exercise. The qualifying time for the treadmill test will then be the time to a horizontal depression or downsloping ST-segment of 1 mm compared to the pre-exercise ST segment as subsequently established by the Biomedical Systems central ECG lab.
- 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).
- Ability to complete the study in compliance with the protocol.
Who cannot join
- 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).
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- 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.
- Clinically significant ECG abnormalities, e.g.: QRS duration >0.12 seconds; QTc >450 ms in males or >460 ms in females;High-grade trioventricular (AV) block; Left bundle branch block(LBBB; Left ventricular hypertrophy(LVH) with secondary ST-T changes; Frequent, recurrent, or sustained ventricular arrhythmia; Resting ST segment depression >1 mm (measured 80 ms beyond the J point) at baseline.
- Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent and comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the trial.
- Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving IMP.
- Any subject with unstable angina.
- Heart failure New York Heart Association (NYHA) Functional Class III or IV.
- Uncontrolled hypertension precluding exercise testing and/or contributing to angina severity (systolic blood pressure [SBP] >200 mmHg or diastolic blood pressure [DBP] >110 mmHg), or significant hypotension (SBP <90 mmHg or DBP <60 mmHg).
- Subjects currently on External Counter Pulsation therapy or who have received this therapy within 3 months prior to the screening date.
- Any mobility or pulmonary complication that impedes the subject's ability to perform an exercise stress test.
- Total fasting serum cholesterol >200 mg/dL (if levels greater than or equal to 200 mg/dL, additional medical interventions can be initiated to bring levels below 200 mg/dL).
- History of heparin-induced thrombocytopenia.
- Subjects with a history of recurrent symptomatic atrial fibrillation or significant ventricular arrhythmias.
- Aortic or mitral valve replacement.
- Subjects who have undergone heart transplantation.
- Medical history and physical examination displaying any evidence that catheterization is contraindicated.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.
- Being tested
- Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose, Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose, Placebo
- Keywords
- Angiogenesis, No-option heart patients, Blocked coronary artery, Revascularization, FGF-1, growth factor
- Medical subject headings
- Coronary Disease, Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low doseCombination product
Up 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 doseCombination product
Up to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session
PlaceboCombination product
Up to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Change in CCS angina score
Change in CCS angina score
Measured: 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)
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study start1 Sep 2027 (estimated)
- Primary completion15 Nov 2029 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venturis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emerson Perin, MD, PhD, Principal investigator, Texas Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117936
- Sponsor's protocol ID
- CVBT-CHD07-01
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2005
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00117936
- Acronym / sponsor ID
- CVBT-CHD07-01
- Keywords
- Angiogenesis, No-option heart patients, Blocked coronary artery, Revascularization, FGF-1, growth factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Venturis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 15 Nov 2029 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Combination Product: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low doseHuman Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - high dose, given as intramyocardial injections via a NOGA Injection Catheter, single cath lab session. |
| 2 | Experimental | Combination Product: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high doseHuman Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose, given as intramyocardial injections via a NOGA Injection Catheter, single cath lab session. |
| 3 | Placebo comparator | Combination Product: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low doseUp to ten intramyocardial injections of low dose FGF 1-141, via a NOGA Injection Catheter, single cath lab session | Combination product | 1 |
| Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high doseUp to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session | Combination product | 2 |
| PlaceboUp to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session | Combination product | 3 |
Primary outcome
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 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
Time frame: baseline to 12 weeks, followed up to one year
Change in CCS angina score
1 secondary outcome
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 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- web site of sponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emerson Perin, MD, PhD principal investigator
Texas Heart Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose and Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose in people with Coronary Disease and Coronary Heart Disease, run by Venturis Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence R Meyerson, PhD (4153066333, LMeyerson@venturistherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.