Safety and Feasibility of the Injectable BL-1040 Implant

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Device: BL-1040

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • Heidelberg University MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BL-1040	Device: BL-1040; 2 mL of BL-1040

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: BioLineRx, Ltd.
• Collaborators: Sheba Medical Center
• Investigators: Principal Investigator: Paul Vermeersch, MD, Antwerp MC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ANTICIPATED): January 1, 2014

Study Registration Dates

• First Submitted: November 12, 2007
• First Submitted That Met QC Criteria: November 13, 2007
• First Posted (ESTIMATE): November 14, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 1040.01