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

SironRX Therapeutics

Status and phase: Unknown; Phase 1

Conditions: Median Sternotomy

Treatments: Biological: JVS-100 or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657045

SRX-001

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Subjects will be randomized to receive injections JVS-100 or placebo.

Treatment:

Biological: JVS-100 or placebo

Biological: JVS-100 or placebo

Biological: JVS-100 or placebo

Cohort 2

Experimental group

Description:

Subjects will be randomized to receive injections JVS-100 or placebo.

Treatment:

Biological: JVS-100 or placebo

Biological: JVS-100 or placebo

Biological: JVS-100 or placebo

Cohort 3

Experimental group

Description:

Subjects will be randomized to receive injections of JVS-100 or placebo.

Treatment:

Biological: JVS-100 or placebo

Biological: JVS-100 or placebo

Biological: JVS-100 or placebo