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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects will be randomized to receive injections JVS-100 or placebo. |
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| Cohort 2 | Experimental | Subjects will be randomized to receive injections JVS-100 or placebo. |
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| Cohort 3 | Experimental | Subjects will be randomized to receive injections of JVS-100 or placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JVS-100 or placebo | Biological | Injections will be delivered depending on sternal incision length. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy J Miller, Ph.D | Contact | 216-445-5588 | tmiller@sironrx.com |
| Name | Affiliation | Role |
|---|---|---|
| Amit Patel, MD | University of Utah | Principal Investigator |
| Robert Michler, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pepin Heart Institute | Recruiting | Tampa | Florida | 33613 | United States |
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| JVS-100 or placebo | Biological | Injections will be delivered depending on sternal incision length. |
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| JVS-100 or placebo | Biological | Injections will be delivered depending on sternal incision length. |
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| Northwestern University Bluhm Cardiovascular Inst | Recruiting | Chicago | Illinois | 60611 | United States |
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| Montefiore Medical Center | Recruiting | New York | New York | 10467 | United States |
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| Summa Health System Hospital | Recruiting | Akron | Ohio | 44304 | United States |
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| University of Utah Hospital | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| Sentara Cardiovascular Research Institute | Recruiting | Norfolk | Virginia | 23507 | United States |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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