Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
- Conditions
- Median Sternotomy
- Interventions
- Biological: JVS-100 or placebo
- Registration Number
- NCT01657045
- Lead Sponsor
- SironRX Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 JVS-100 or placebo Subjects will be randomized to receive injections JVS-100 or placebo. Cohort 2 JVS-100 or placebo Subjects will be randomized to receive injections JVS-100 or placebo. Cohort 3 JVS-100 or placebo Subjects will be randomized to receive injections of JVS-100 or placebo.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Pepin Heart Institute
🇺🇸Tampa, Florida, United States
Northwestern University Bluhm Cardiovascular Inst
🇺🇸Chicago, Illinois, United States
Summa Health System Hospital
🇺🇸Akron, Ohio, United States
Montefiore Medical Center
🇺🇸New York City, New York, United States