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

This study is currently recruiting participants.
Verified July 2013 by SironRX Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
SironRX Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01657045
First received: August 1, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Median Sternotomy
Biological: JVS-100 or placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by SironRX Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the preliminary efficacy of ascending doses JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects will be randomized to receive injections JVS-100 or placebo.
Biological: JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Experimental: Cohort 2
Subjects will be randomized to receive injections JVS-100 or placebo.
Biological: JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Experimental: Cohort 3
Subjects will be randomized to receive injections of JVS-100 or placebo.
Biological: JVS-100 or placebo
Injections will be delivered depending on sternal incision length.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657045

Contacts
Contact: Timothy J Miller, Ph.D 216-445-5588 tmiller@sironrx.com

Locations
United States, Florida
Pepin Heart Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Yvonne Gopsill, RN    813-615-7527    yvonne.gopsill@ahss.org   
Principal Investigator: Marc Bloom, MD         
United States, Illinois
Northwestern University Bluhm Cardiovascular Inst Recruiting
Chicago, Illinois, United States, 60611
Contact: Jade Irving    312-695-6854    jirving@nmh.org   
Principal Investigator: Patrick McCarthy, MD         
United States, New York
Montefiore Medical Center Recruiting
New York City, New York, United States, 10467
Contact: Nadia Sookraj, RN    718-920-6636    nsookraj@montefiore.org   
Principal Investigator: Robert Michler, MD         
United States, Ohio
Summa Health System Hospital Recruiting
Akron, Ohio, United States, 44304
Contact: Robin Roth, RN    330-375-3931    rothr@summahealth.org   
Principal Investigator: Eric Espinal, MD         
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Patty Meldrum, RN    801-581-4121    patty.meldrum@hsc.utah.edu   
Principal Investigator: Amit Patel, MD         
United States, Virginia
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant, RN    757-388-4024    MMBULLIV@sentara.com   
Principal Investigator: Michael McGrath, MD         
Sponsors and Collaborators
SironRX Therapeutics, Inc.
Investigators
Principal Investigator: Amit Patel, MD University of Utah
Principal Investigator: Robert Michler, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: SironRX Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01657045     History of Changes
Other Study ID Numbers: SRX-001
Study First Received: August 1, 2012
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SironRX Therapeutics, Inc.:
Cicatrix
Wound healing

ClinicalTrials.gov processed this record on April 16, 2014