Recruiting

Phase 1

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

Sponsor:

SironRX Therapeutics, Inc.

Code:

NCT01657045

Conditions

Median Sternotomy

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

JVS-100 or placebo

Study Details

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.

Conditions

Median Sternotomy

Study ID

NCT01657045

Start date

Jul, 2012

Status verified date

Jul, 2013

Completion date

Jul, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Subjects will be randomized to receive injections JVS-100 or placebo.

experimental: Cohort 2

Subjects will be randomized to receive injections JVS-100 or placebo.

experimental: Cohort 3

Subjects will be randomized to receive injections of JVS-100 or placebo.

Interventions

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.

Primary outcome 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. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Timothy J Miller, Ph.D

216-445-5588 tmiller@sironrx.com

Locations

Pepin Heart Institute

Recruiting

Tampa, Florida, United States, 33613

Contacts

Yvonne Gopsill, RN

813-615-7527 yvonne.gopsill@ahss.org

Principal Investigator:

Marc Bloom, MD

Northwestern University Bluhm Cardiovascular Inst

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jade Irving

312-695-6854 jirving@nmh.org

Principal Investigator:

Patrick McCarthy, MD

Montefiore Medical Center

Recruiting

New York City, New York, United States, 10467

Contacts

Nadia Sookraj, RN

718-920-6636 nsookraj@montefiore.org

Principal Investigator:

Robert Michler, MD

Summa Health System Hospital

Recruiting

Akron, Ohio, United States, 44304

Contacts

Robin Roth, RN

330-375-3931 rothr@summahealth.org

Principal Investigator:

Eric Espinal, MD

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Patty Meldrum, RN

801-581-4121 patty.meldrum@hsc.utah.edu

Principal Investigator:

Amit Patel, MD

Sentara Cardiovascular Research Institute

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Melinda Bullivant, RN

757-388-4024 MMBULLIV@sentara.com

Principal Investigator:

Michael McGrath, MD

More Information

Sponsor

SironRX Therapeutics, Inc.

Last update posted

Jul 23, 2013

Last verified

Jul, 2013

Keywords

Cicatrix
Wound healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SironRX Therapeutics, Inc. on 2013-07-23.