study to evaluate the safety and efficacy of dermal injections of jvs-100 given to adults receiving median sternotomy

Conditions: Median Sternotomy

Summary: this study will investigate the safety and efficacy of using jvs-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery. twenty-five (25) subjects receiving a median sternotomy of 16 - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be followed for 6 months post-dosing. three cohorts of approximately 8 subjects each will be enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of needle-free dermal injections of either jvs-100 or placebo. jvs-100 or placebo will be delivered along the edge of the sternal wound using a needle-free injection device that has fda-clearance for subcutaneous injections.


Eligibility criteria:
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 * subjects with bmi 25 - 40 kg/m2 * all subjects age 50 or older must have had a fecal occult blood test (fobt) or fecal immunochemical test (fit) that was negative within the last year or a colonoscopy within the last 10 years * women age 40 - 65 must have had a papanicolaou (pap) test that was negative within the last 5 years unless a total hysterectomy has been previously performed for benign disease * women age 40 or older must have had a mammogram that was negative within the last year * all diabetic subjects must have had an ophthalmologic exam within the last year showing no active proliferative retinopathy. 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

Keywords: cicatrix wound healing