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REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts (RECONSTRUCT)

This study is not yet open for participant recruitment.
Verified February 2012 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Eduardo Marban, MD, PhD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01496209
First received: December 19, 2011
Last updated: February 15, 2012
Last verified: February 2012
History of Changes

December 19, 2011
February 15, 2012
July 2012
September 2014   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01496209 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts
Not Provided

A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ischemic Cardiomyopathy
  • Chronic Ischemic Cardiomyopathy
  • Biological: Endomyocardial injections of allogeneic Human CSps
    NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.
    Other Name: Biological: Allogeneic Human CSps (or alloCSps)
  • Biological: Endomyocardial injections of vehicle only.
    NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.
  • Sham Comparator: Placebo control
    Intervention: Biological: Endomyocardial injections of vehicle only.
  • Experimental: Group: Cardiosphere Treatment
    Biological: Allogeneic Human Cardiospheres (allogeneic CSps or alloCSps), a 3D micro-tissue heart-derived cell therapy product. Subjects will receive 150 million cell-equivalents of alloCSps via endomyocardial injection (10 million per site at 15 peri-infarct sites)
    Intervention: Biological: Endomyocardial injections of allogeneic Human CSps
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with ischemic cardiomyopathy (EF >10 and <40% by functional imaging [ECHO, CT, MRI, contrast ventriculography])
  • Symptomatic heart failure of NYHA Class 2 or 3
  • History of prior remote (>3 mo) myocardial infarction and/or documented obstructive coronary artery disease with corresponding dysfunctional segments by functional imaging
  • Age > 18 years
  • Ability to provide informed consent and follow-up with protocol procedures

Exclusion Criteria:

  • Documented myocardial infarction within 3 months (120 days)
  • Known or suspected left ventricular thrombus
  • Non-cardiovascular disease with life expectancy of < 3 years
  • Absence of significant gadolinium-enhanced scar (>10% of LV mass) at baseline MRIc
  • Positive panel-reactive antibodies (PRA)
  • Need for further revascularization clinically indicated at the time the patient is assessed for participation in the clinical trial. This will be determined by a cardiologist who is not an investigator in the clinical trial. No further revascularization may be indicated by no arteries with significant stenosis, the location, and extent of any stenosis may not be suitable for angioplasty, the distal vessels may not be suitable for placement of bypass grafts, and/or the patient declines angioplasty or bypass surgery.
  • NYHA IV heart failure
  • History of aortic stenosis/insufficiency
  • Requirement for chronic immunosuppressive therapy
  • Participation in an on-going protocol studying an experimental drug or device
  • Diagnosis of congenital or genetically-transmitted cardiomyopathy
  • Current alcohol or drug abuse because of anticipated difficulty in complying with protocol-related procedures
  • Pregnancy or child-bearing potential without use of effective contraception. Men intending to "father" children are also excluded.
  • Human Immunodeficiency virus infection
  • Viral hepatitis
  • Uncontrolled diabetes and/or hemoglobin A1C > 8.5%
  • Abnormal liver function (SGPT > 3 times the upper reference range) and/or hematology (hematocrit <25%, WBC <3000, Platelets <100,000) studies without a reversible, identifiable cause
  • Ventricular tachycardia or fibrillation not associated with an acute ischemic episode
  • Canadian Cardiovascular Society Angina Class 3 or 4
  • History of cardiac tumor or cardiac tumor demonstrated or suspected on MRI other imaging modality
  • Previous stem cell therapy/treatment
  • Individuals who are not fluent in English
Both
18 Years and older
No
Contact: Tracey S. Gerez, BS, MA, CCRP 310.423.1231 tracey.gerez@cshs.org
Contact: Michelle Domingo, CCRP 310.423.3875 DomingoM@cshs.org
United States
 
NCT01496209
RECONSTRUCT
No
Eduardo Marban, MD, PhD, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Eduardo Marban, MD, PhD Cedars-Sinai Medical Center, Heart Institute
Cedars-Sinai Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP