Clinical Trial: Cardio Vascu-Grow for treatment of coronary heart disease

This study is currently recruiting patients.

Sponsors and Collaborators: Cardio Vascular Genetic Engineering
Cardiovascular Clinical Research
Information provided by: Cardio Vascular Genetic Engineering

Purpose

Treatment for no-options heart patients with coronary artery disease. Procedure involves the injection into the heart of a protein growth factor that stimulates the growth of new blood vessels around blocked coronary arteries.

Condition Treatment or Intervention Phase
Coronary Disease
Coronary Heart Disease
Myocardial Ischemia
Coronary Arteriosclerosis
 Drug: Human Fibroblast Growth Factor 1
Phase I
Phase II

MedlinePlus related topics:  Coronary Disease;   Heart Diseases;   Heart Diseases--Prevention;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  32

Study start: December 2002

Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.

Eligibility

Ages Eligible for Study:  25 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

3 month history of chronic, stable angina.

Mini-thoracotomy and anesthesia not contraindicated.

Not eligible for by-pass or PTCA procedures.

One/two/three vessel disease with documentation of greater than 70% narrowing of a major coronary artery, or diffuse coronary artery disease.

Heart ejection fraction >25%.

Normal retinal eye exam.

Subjects must be on conventional medication including one of the following: beta-blockers, calcium entry blockers, long-acting nitrates.

Female subjects must be post-menopausal or sterilized, or if of child-bearing age, not breast-feeding, on contraceptive drugs or devices, and have no intention of becoming pregnant during the course of the study.


Location and Contact Information

Mary Riggs      301-208-9100    maryr@c2r.net

Maryland
      St. Joseph Medical Center, Towson,  Maryland,  21204,  United States; Recruiting
John C Laschinger, M.D.  410-583-1175 
Mary Riggs, R.N.  301-208-9100    Maryr@C2R.net 
John C Laschinger, M.D.,  Principal Investigator

Pennsylvania
      Penn State Milton Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
Mary Riggs, R.N.  301-208-9100    Maryr@C2R.net 
John Boehmer, M.D.,  Principal Investigator

More Information

web site of sponsor

Study ID Numbers:  CVGE-2002-01
Record last reviewed:  December 2002
Last Updated:  October 13, 2004
Record first received:  March 14, 2002
ClinicalTrials.gov Identifier:  NCT00032318
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005