REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts

NCT ID: NCT01496209

Last Updated: 2014-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-09-30

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.

Conditions

Ischemic Cardiomyopathy; Chronic Ischemic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo control

Group Type: SHAM_COMPARATOR

Endomyocardial injections of vehicle only.

Intervention Type: BIOLOGICAL

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

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)

Group Type: EXPERIMENTAL

Endomyocardial injections of allogeneic Human CSps

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

Endomyocardial injections of vehicle only.

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Biological: Allogeneic Human CSps (or alloCSps)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Marban, MD, PhD

Director, Heart Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduardo Marban, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center, Heart Institute

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

RECONSTRUCT

Identifier Type: -

Identifier Source: org_study_id