Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy

Exclusion Criteria

• •Subject is scheduled for mechanical device assistance or, heart transplantation
• •Class IV heart failure
• •Subject had acute myocardial infarction less than 3 days prior to scheduled surgery
• •Subject is undergoing urgent bypass surgical procedure
• •History of scleroderma, a connective tissue disorder, rheumatoid arthritis, or ankylosing spondylitis or systemic lupus erythematosus (SLE)
• •Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control
• •Life expectancy of \< 1 year
• •Diabetes mellitus with HgbA1C \>10.5% tested within 2 weeks prior to surgery
• •Existing scarring in the area of study
• •Subject has received a cytotoxic agent or has a history of chest radiation therapy and/or will likely require such treatment in the 30 day period following surgery, not including use of radiation for diagnostic imaging, e.g., PET Scan, CT SCAN, Fluro, Myocardial Perfusion (SPECT).
• •Chest tattoos over the sternum, breast implants, prior mastectomies or lumpectomies
• •Subject plans to use an alternative/accessory wound healing treatment
• •Infection being treated with systemic antibiotics within 3 days of scheduled surgery
• •Chronic kidney disease (stage 5) requiring dialysis
• •Significant Hepatic disease
• •Significant is known to be infected with HBV, HIV or HCV
• •Clinically significant elevations or decreases in PT/PTT/INR/WBC
• •Concurrent medical condition that is associated with prolonged recovery from surgery (e.g., significant respiratory disease, high risk for ventilator dependence, current use of systemic steroids)
• •Subject has cognitive impairment
• •Any patient with a history of cancer with the exception of: 1) The cancer was limited to curable non-melanoma skin malignancies; 2) The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence.
• •Men unwilling to agree to barrier contraception unless previously received a vasectomy
• •Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
• •Previous treatment with an angiogenic growth factor or with stem cell therapy within 1 year
• •Participation in another clinical trial of an investigational agent in the previous 30 days
• •History of drug or alcohol abuse in the past year