REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts (RECONSTRUCT)

February 10, 2014 updated by: Eduardo Marbán, MD, PhD, Cedars-Sinai Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Biological: Allogeneic Human CSps (or alloCSps)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Eduardo Marban, MD, PhD, Cedars-Sinai Medical Center, Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECONSTRUCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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