REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts

Ischemic Cardiomyopathy Clinical Trial

— RECONSTRUCT  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01496209
• Other study ID #: RECONSTRUCT
• Status: Withdrawn
• Phase: Phase 1
• First received: December 19, 2011
• Last updated: February 10, 2014
• Start date: July 2015
• Est. completion date: September 2017

Study information

• Verified date: February 2014
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Chronic Ischemic Cardiomyopathy
• Ischemia
• Ischemic Cardiomyopathy

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States,