Median Sternotomy
Conditions
Keywords
Cicatrix, Wound healing
Brief 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.
Interventions
BIOLOGICALJVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Sponsors
SironRX Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of ascending doses of JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the preliminary efficacy of ascending doses JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery. | 6 months |
Countries
United States
Contacts
Primary ContactTimothy J Miller, Ph.D
Outcome results
None listed