NCT01657045Unknown1 期
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
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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.
时间窗: 6 months
次要结局
- 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)
研究者
研究点 (12)
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