REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts (RECONSTRUCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496209
Recruitment Status : Withdrawn
First Posted : December 21, 2011
Last Update Posted : February 12, 2014
Information provided by (Responsible Party):
Eduardo Marban, MD, PhD, Cedars-Sinai Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Chronic Ischemic Cardiomyopathy Biological: Endomyocardial injections of allogeneic Human CSps Biological: Endomyocardial injections of vehicle only. Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
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)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Eduardo Marban, MD, PhD, Director, Heart Institute, Cedars-Sinai Medical Center Identifier: NCT01496209     History of Changes
Other Study ID Numbers: RECONSTRUCT
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Eduardo Marban, MD, PhD, 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