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REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts (RECONSTRUCT)

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Eduardo Marban, MD, PhD, Cedars-Sinai Medical Center Identifier:
First received: December 19, 2011
Last updated: February 10, 2014
Last verified: February 2014
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.

Condition Intervention Phase
Ischemic Cardiomyopathy
Chronic Ischemic Cardiomyopathy
Biological: Endomyocardial injections of allogeneic Human CSps
Biological: Endomyocardial injections of vehicle only.
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Cedars-Sinai Medical Center:

Enrollment: 0
Study Start Date: July 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Placebo control Biological: Endomyocardial injections of vehicle only.
NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.
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)
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01496209

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Eduardo Marban, MD, PhD Cedars-Sinai Medical Center, Heart Institute
  More Information

Responsible Party: Eduardo Marban, MD, PhD, Director, Heart Institute, Cedars-Sinai Medical Center Identifier: NCT01496209     History of Changes
Other Study ID Numbers: RECONSTRUCT
Study First Received: December 19, 2011
Last Updated: February 10, 2014

Keywords provided by Cedars-Sinai Medical Center:
Myocardial Infarction
Ventricular Dysfunction, Left
Heart Disease
Cardiovascular Disease
Chronic Ischemia

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Cardiovascular Diseases processed this record on May 24, 2017