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

NCT01657045 | Unknown Phase 1 DMC

• 1 other identifier: SRX-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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

Keywords

Cicatrix; Wound healing

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• To investigate the preliminary efficacy of ascending doses JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery.

  6 months

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Biological: JVS-100 or placebo

Cohort 2

EXPERIMENTAL

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

Biological: JVS-100 or placebo

Cohort 3

EXPERIMENTAL

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

Biological: JVS-100 or placebo

Interventions

JVS-100 or placebo BIOLOGICAL

Injections will be delivered depending on sternal incision length.

Cohort 1

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SironRX Therapeutics, Inc.: lead

Study Sites (6)

Pepin Heart Institute

Tampa, Florida, 33613, United States

RECRUITING

Northwestern University Bluhm Cardiovascular Inst

Chicago, Illinois, 60611, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10467, United States

RECRUITING

Summa Health System Hospital

Akron, Ohio, 44304, United States

RECRUITING

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

RECRUITING

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amit Patel, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Robert Michler, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy J Miller, Ph.D

CONTACT

216-445-5588; tmiller@sironrx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 3, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

US (6)