Safety and Feasibility of the Injectable BL-1040 Implant

Study Overview
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Brief Summary
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This is a Phase I, multi-center, open label study designed to assess the safety and feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial tissue.

Detailed Description
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ENDPOINTS Preliminary safety endpoints Occurrence of all adverse events including but not limited to All MIs Cardiovascular hospitalization Serious ventricular arrhythmias sustained: VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse]) VF symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block Symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) Renal failure Stroke Death Secondary safety endpoints Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP

Official Title
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Safety and Feasibility of the Injectable BL-1040 Implant

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Device: BL-1040


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent 18 to 75 years of age, inclusive Male or female Negative pregnancy test for women of child-bearing potential, or surgically sterile, or post menopausal Acute MI defined as: Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: Ischemic symptoms; Development of pathologic Qwaves on the ECG; ECG changes indicative of ischemia (ST segment elevation or depression) First anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads]) Regional wall motion score index (at least 4 out of 16 akinetic segments) One or more of the following: LVEF >20% and <45% measured and calculated by 2-dimensional measurement Biomarkers: peak CK > 2000 IU Infarct size > 25% as measured by MRI Successful revascularization with PCI with 1 stent only, within 7 days of the index MI At time of application of study device, patient must have patent infarct related artery (IRA) and TIMI flow grade = 3 Exclusion Criteria: History of CHF, Class I to Class IV, as per NYHA criteria History of prior LV dysfunction At time of application of study device - Killip III-IV (pulmonary edema, cardiogenic shock - hypotension systolic < 90 mmHg and evidence of peripheral hypoperfusion oliguria, cyanosis, sweating) or HR > 100 bpm Prior CABG Prior MI History of stroke Significant valvular disease (moderate or severe) Patient is a candidate for CABG or PCI on non-IRA Patient is being considered for CRT within the next 30 days Renal insufficiency (eGFR < 60) Chronic liver disease (> 3 times upper limit of normal) Life expectancy < 12 months Current participant in another clinical trial, or participation in another trial within the last 6 months Any contraindication to coronary angiography, MRI or PCI procedures Patient taking anti-coagulation medication prior to MI Pregnant or lactating women; pregnancy confirmed by urine pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BL-1040<br> | Device: BL-1040<br>* 2 mL of BL-1040<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of all AEs including but not limited to All MIs CV hospitalization Serious ventricular arrhythmias sustained: Symptomatic heart failure Renal failure Stroke Death |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP |  | 6 months |