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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014