Median SternotomyPhase 1NCT01657045
Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
A Phase 1 study of Median Sternotomy, run by SironRX Therapeutics, Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Median Sternotomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2012to Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Summa Health System Hospital
Akron, Ohio, 44304
Robin Roth, RN, 330-375-3931, rothr@summahealth.org
Eric Espinal, MD
- Recruiting
Northwestern University Bluhm Cardiovascular Inst
Chicago, Illinois, 60611
Jade Irving, 312-695-6854, jirving@nmh.org
Patrick McCarthy, MD
- Recruiting
Montefiore Medical Center
New York, New York, 10467
Nadia Sookraj, RN, 718-920-6636, nsookraj@montefiore.org
Robert Michler, MD
- Recruiting
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Melinda Bullivant, RN, 757-388-4024, MMBULLIV@sentara.com
Michael McGrath, MD
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Patty Meldrum, RN, 801-581-4121, patty.meldrum@hsc.utah.edu
Amit Patel, MD
- Recruiting
Pepin Heart Institute
Tampa, Florida, 33613
Yvonne Gopsill, RN, 813-615-7527, yvonne.gopsill@ahss.org
Marc Bloom, MD
About this study
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
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
- Being tested
- JVS-100 or placebo
- Keywords
- Cicatrix, Wound healing
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JVS-100 or placeboBiological
Injections will be delivered depending on sternal incision length.
JVS-100 or placeboBiological
Injections will be delivered depending on sternal incision length.
JVS-100 or placeboBiological
Injections will be delivered depending on sternal incision length.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects will be randomized to receive injections JVS-100 or placebo. Receives: Biological: JVS-100 or placebo |
| Cohort 2 | Experimental | Subjects will be randomized to receive injections JVS-100 or placebo. Receives: Biological: JVS-100 or placebo |
| Cohort 3 | Experimental | Subjects will be randomized to receive injections of JVS-100 or placebo. Receives: Biological: JVS-100 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median SternotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SironRX Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amit Patel, MD, Principal investigator, University of UtahRobert Michler, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657045
- Sponsor's protocol ID
- SRX-001
- Status last verified
- Jul 2013
- First submitted
- 1 Aug 2012
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01657045
- Acronym / sponsor ID
- SRX-001
- Conditions
- Median Sternotomy
- Keywords
- Cicatrix, Wound healing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- SironRX Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: JVS-100 or placeboSubjects will be randomized to receive injections JVS-100 or placebo. |
| Cohort 2 | Experimental | Biological: JVS-100 or placeboSubjects will be randomized to receive injections JVS-100 or placebo. |
| Cohort 3 | Experimental | Biological: JVS-100 or placeboSubjects will be randomized to receive injections of JVS-100 or placebo. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JVS-100 or placeboInjections will be delivered depending on sternal incision length. | Biological | Cohort 1 |
| JVS-100 or placeboInjections will be delivered depending on sternal incision length. | Biological | Cohort 2 |
| JVS-100 or placeboInjections will be delivered depending on sternal incision length. | Biological | Cohort 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
Related trials for Median Sternotomy
Not yet recruiting
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
Chronic Poststernotomy Pain
Active, not recruiting
Early Rehabilitation in Patients Following Major Cardiac Surgery: Changes in Functional Capacity and Energy Efficiency in Walking and ADLs.
Cardiac Surgery, Median Sternotomy
Recruiting
SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy
Sternotomy
Not yet recruiting
ASPB-PIPB Combination in Cardiac Surgery
Postoperative Pain, Cardiac Surgery
Recruiting
Effects of Myofascial Release on Cardiac Patients After Median Sternotomy
Aortic Aneurysm and Dissection, Coronary Artery Disease (CAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Patel, MD principal investigator
University of Utah
Robert Michler, MD principal investigator
Montefiore Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Median Sternotomy, run by SironRX Therapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy J Miller, Ph.D (216-445-5588, tmiller@sironrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.