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

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

NCT01657045•SironRX Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

40 - 80 years

Sex

ALL

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).
+15 more criteria

Locations (6)

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

Key Dates

Start Date

July 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

July 1, 2014

Last Updated

July 23, 2013

Enrollment

ESTIMATED participants

Conditions

Median Sternotomy

Interventions

JVS-100 or placebo

BIOLOGICAL

JVS-100 or placebo

BIOLOGICAL

JVS-100 or placebo

BIOLOGICAL

Contacts

Timothy J Miller, Ph.D

CONTACT

216-445-5588 tmiller@sironrx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy

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