Clinical trial NCT01657045: Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Median Sternotomy
Keywords: Cicatrix
Wound healing
Lead sponsor: SironRX Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-03
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: To investigate the preliminary efficacy of ascending doses JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Pepin Heart Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University Bluhm Cardiovascular Inst
state: Illinois
city: New York City
country: United States
facility: Montefiore Medical Center
state: New York
city: Akron
country: United States
facility: Summa Health System Hospital
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
Study officials:
affiliation: University of Utah
name: Amit Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Robert Michler, MD
role: PRINCIPAL_INVESTIGATOR
References: