Can a heart injection grow new blood vessels?
NCT ID NCT00117936
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial tests whether injecting a growth factor called FGF-1 directly into the heart can help people with severe coronary heart disease who have no other treatment options. The study compares low and high doses of FGF-1 against a placebo, using a special catheter to deliver the injections. The goal is to see if the growth factor can stimulate new blood vessel growth, improve blood flow, and reduce chest pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Human recombinant fibroblast growth factor-1 (FGF-1), injected directly into the heart muscle
- What this could lead to
- If it works, this could offer a new treatment option for people with severe coronary heart disease who have no other options, potentially reducing chest pain and improving blood flow.
- What could go wrong
- This is a Phase 2 trial, so results are preliminary. The treatment involves invasive heart injections, and it may not improve symptoms or blood flow more than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. Sign an informed consent form. 2. Age ≥25 and ≤75 years, either gender, and any race. 3. At least a 3 month history of chronic, stable angina and is relieved by rest and/or nitroglycerin. 4. Documented symptomatic CCS Angina Classification of III to IV despite use of optimal medical therapy as noted in Inclusion Criterion 10. 5. 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. 6. 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. 7. demonstrate a radionuclide or angiographically determined left ventricular ejection fraction (LVEF) ≥30%. 8. Pre-operative proof of reversible ischemia. 9. No evidence of proliferative retinopathy or significant non-proliferative retinopathy. 10. 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. 11. Exercise duration during the qualifying treadmill tests at Visit 1 and Visit 2 is ≥3 and ≤9 minutes on a modified Bruce protocol. 12. 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. 13. 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. 14. A forced vital capacity (FVC) of ≥30%. 15. A negative pregnancy test in women of childbearing potential at Screening. 16. 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. 17. Negative cancer screening tests according to the American Cancer Society (\[ACS\] Appendix 13.8). 18. Ability to complete the study in compliance with the protocol. Exclusion criteria 1. History of undergoing a CABG, PTCA or TMR or evidence of an acute MI in the last 3 months. 2. 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. 3. 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." 4. 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. 5. Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography. 6. Creatine kinase (CK) levels \>3 x upper limit of normal (ULN). 7. Renal insufficiency requiring dialysis or laboratory evidence of a serum creatinine \>2.0 mg/dL. 8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 x ULN. 9. 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). 10. History of blood cell diseases. 11. Poorly controlled insulin-dependent diabetes mellitus (HbA1c \>8%) 12. Pre-existing retinal disease, including proliferative retinopathy, severe nonproliferative retinopathy. 13. Use of any illicit recreational drugs within the past year. 14. A positive test result for human immunodeficiency virus (HIV) antibody. 15. Screening ECG results demonstrating recent evidence of transmural ischemia. 16. 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. 17. Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years. 18. 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. 19. 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. 20. Any subject with unstable angina. 21. Heart failure New York Heart Association (NYHA) Functional Class III or IV. 22. 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). 23. Subjects currently on External Counter Pulsation therapy or who have received this therapy within 3 months prior to the screening date. 24. Any mobility or pulmonary complication that impedes the subject's ability to perform an exercise stress test. 25. 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). 26. History of heparin-induced thrombocytopenia. 27. Subjects with a history of recurrent symptomatic atrial fibrillation or significant ventricular arrhythmias. 28. Aortic or mitral valve replacement. 29. Subjects who have undergone heart transplantation. 30. Medical history and physical examination displaying any evidence that catheterization is contraindicated.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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