REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts (RECONSTRUCT)

Cedars-Sinai Medical Center

Status and phase: Withdrawn; Phase 1

Conditions: Chronic Ischemic Cardiomyopathy; Ischemic Cardiomyopathy

Treatments: Biological: Endomyocardial injections of vehicle only.; Biological: Endomyocardial injections of allogeneic Human CSps

Study type: Interventional

Funder types: Other

Identifiers

NCT01496209

RECONSTRUCT

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Placebo control

Sham Comparator group

Treatment:

Biological: Endomyocardial injections of vehicle only.

Group: Cardiosphere Treatment

Experimental group

Description:

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)

Treatment:

Biological: Endomyocardial injections of allogeneic Human CSps