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

Inclusion Criteria:

• Men and women 40 - 80 years of age inclusive
• Patients undergoing median sternotomy for cardiac surgical procedures, with incision length of 16-25 cm
• Subject must be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent
• BMI 25 - 40 kg/m2

Exclusion Criteria:

• Prior sternotomy or thoracotomies
• 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 >8.5% tested within 2 weeks prior to surgery
• Subject has diabetic retinopathy
• 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
• 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