NCT01496209

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
3.5 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

2.2 years

First QC Date

December 19, 2011

Last Update Submit

February 10, 2014

Conditions

Ischemic CardiomyopathyChronic Ischemic Cardiomyopathy

Keywords

InfarctionMyocardial InfarctionVentricular Dysfunction, LeftHeart DiseaseCardiovascular DiseaseChronic Ischemia

Study Arms (2)

Placebo control

SHAM COMPARATOR
Biological: Endomyocardial injections of vehicle only.

Group: Cardiosphere Treatment

EXPERIMENTAL

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

Interventions

Endomyocardial injections of allogeneic Human CSpsBIOLOGICAL

NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.

Also known as: Biological: Allogeneic Human CSps (or alloCSps)
Group: Cardiosphere Treatment
Endomyocardial injections of vehicle only.BIOLOGICAL

NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.

Placebo control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

InfarctionMyocardial InfarctionVentricular Dysfunction, LeftHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisMyocardial IschemiaVascular DiseasesVentricular Dysfunction

Study Officials

  • Eduardo Marban, MD, PhD

    Cedars-Sinai Medical Center, Heart Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Heart Institute

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

US(1)