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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Needle-free Dermal Injection to Cohorts of Adults Receiving Surgical Sternotomy Incisions

Conditions
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Median Sternotomy

Intervention / Treatment
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* Biological: JVS-100 or placebo
* Biological: JVS-100 or placebo
* Biological: JVS-100 or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Subjects will be randomized to receive injections JVS-100 or placebo. | Biological: JVS-100 or placebo<br>* Injections will be delivered depending on sternal incision length.<br>|
| Experimental: Cohort 2<br>Subjects will be randomized to receive injections JVS-100 or placebo. | Biological: JVS-100 or placebo<br>* Injections will be delivered depending on sternal incision length.<br>|
| Experimental: Cohort 3<br>Subjects will be randomized to receive injections of JVS-100 or placebo. | Biological: JVS-100 or placebo<br>* Injections will be delivered depending on sternal incision length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cicatrix, Wound healing