Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
NCT ID: NCT01657045
Last Updated: 2013-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
25 participants
INTERVENTIONAL
2012-07-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
Subjects will be randomized to receive injections JVS-100 or placebo.
JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Cohort 2
Subjects will be randomized to receive injections JVS-100 or placebo.
JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Cohort 3
Subjects will be randomized to receive injections of JVS-100 or placebo.
JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Interventions
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JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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SironRX Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amit Patel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Robert Michler, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Pepin Heart Institute
Tampa, Florida, United States
Northwestern University Bluhm Cardiovascular Inst
Chicago, Illinois, United States
Montefiore Medical Center
New York, New York, United States
Summa Health System Hospital
Akron, Ohio, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SRX-001
Identifier Type: -
Identifier Source: org_study_id
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