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

Median Sternotomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01657045
• Other study ID #: SRX-001
• Status: Recruiting
• Phase: Phase 1
• First received: August 1, 2012
• Last updated: July 22, 2013
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2013
• Source: SironRX Therapeutics, Inc.
• Contact: Timothy J Miller, Ph.D
• Phone: 216-445-5588
• Email: tmiller[@]sironrx.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Median Sternotomy

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Summa Health System Hospital	Akron	Ohio
United States	Northwestern University Bluhm Cardiovascular Inst	Chicago	Illinois
United States	Montefiore Medical Center	New York City	New York
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Pepin Heart Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
SironRX Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No