Health Trials

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

ConditionsCoronary DiseaseCoronary Heart DiseaseMyocardial IschemiaCoronary Arteriosclerosis
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

Qualifiers

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

Treatments tested in this trial

  • Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose
  • Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose
  • Placebo

Treatment groups

150 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Venturis Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov