Safety and Feasibility of the Injectable BL-1040 Implant

NCT00557531 | Unknown Phase 1 DMC

• 1 other identifier: 1040.01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

BL-1040

EXPERIMENTAL

Device: BL-1040

Interventions

BL-1040 DEVICE

2 mL of BL-1040

BL-1040

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioLineRx, Ltd.: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Heidelberg University MC

Heidelberg, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Paul Vermeersch, MD

  Antwerp MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2014
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

DE (1)