FGF: Patient Information

What is it? Fibroblast Growth Factor (FGF) is a protein that is naturally produced in your body to start the growth of tiny arteries, called collaterals, where existing blood flow is limited. For example, when the arteries that deliver blood to your heart muscle, called coronary arteries, are narrowed or blocked, your body will secrete FGF to grow new collaterals. These new arteries will deliver blood flow to the areas that are compromised. However, collaterals are much smaller than the major arteries in your heart and deliver smaller amounts of blood flow to the heart muscle.

How do you get FGF? FGF is an investigational drug and is available only in clinical trials that are under the Federal Drug Administration's (FDA) supervision. It is not approved by the FDA for general use and it is currently being studied in a Phase II clinical trial. Testing of FGF on human subjects is in the initial stages. The standard phases used by the FDA are listed below.

Phase I - The main purpose is to determine the correct dose and initial safety results in people. This phase of the study is complete for FGF. The drug appears safe and there were encouraging results.
Phase II - This phase is designed to evaluate the effectiveness of the drug. One fourth (25%) of the patients participating in the study will receive a placebo (no drug). The other 75% will receive one of three doses of FGF. One group must receive placebo to prove that FGF works. This phase should take about a year.
Phase III - This phase will entail a large-scale study with many patients. It should also take 1 year.
FDA Approval - The results of the phases are submitted to the FDA and it will probably take 2-3 years for approval.

What's involved with the FGF study? The FGF Phase II clinical trial is being done at about 20 hospitals in the United States. Patients must go through a screening process to evaluate if they qualify for the study (including treadmill exercise tests, cancer screening, and eye exams). Once it is determined that they qualify, patients sign a consent form and are enrolled into the clinical trial. The study drug is delivered to the heart directly into the coronary arteries during an angiogram. Patients are followed for 6 months.

Who qualifies? There is a extensive screening process for patients enrolled in the FGF clinical trail. The following are some of the major qualifications:

Chest pain/angina which interferes with their quality of life
Abnormal nuclear perfusion scan
Abnormal coronary angiogram and not a good candidate for surgery or angioplasty

Exclusions for the study include:

A history of cancer in the last 10 years (because of the potential for growth of vessels that might nourish tumors)
Severe eye disease i.e., retinopathy (because of the risk of growing new vessels in already compromised eyes)
Abnormal kidney function

Participants must be willing to be seen at Hennepin County Medical Center approximately 7-10 times over the first 30 days. After that, they must return for 7-, 30-, 90-, and 180-day follow-up visits.

If you feel you are a candidate for this study, please e-mail us at
FGF-VEGF@mmrfweb.org and include the following information:
1. Do you experience chest pain or angina?
2. Are you a candidate for heart bypass surgery or angioplasty?
3. Are you able to perform a treadmill stress test?
4. Do you have normal kidney function?
5. Do you have a history of cancer within the last 10 years?
6. If you are a diabetic, do you have trouble with your eyes (i.e. blindness, retinopathy, neovascularization)?

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