search
Back to results

REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts (RECONSTRUCT)

Primary Purpose

Ischemic Cardiomyopathy, Chronic Ischemic Cardiomyopathy

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endomyocardial injections of allogeneic Human CSps
Endomyocardial injections of vehicle only.
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring Infarction, Myocardial Infarction, Ventricular Dysfunction, Left, Heart Disease, Cardiovascular Disease, Chronic Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Placebo control

Group: Cardiosphere Treatment

Arm 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)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 19, 2011
Last Updated
February 10, 2014
Sponsor
Cedars-Sinai Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01496209
Brief Title
REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts
Acronym
RECONSTRUCT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy, Chronic Ischemic Cardiomyopathy
Keywords
Infarction, Myocardial Infarction, Ventricular Dysfunction, Left, Heart Disease, Cardiovascular Disease, Chronic Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo control
Arm Type
Sham Comparator
Arm Title
Group: Cardiosphere Treatment
Arm Type
Experimental
Arm 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)
Intervention Type
Biological
Intervention Name(s)
Endomyocardial injections of allogeneic Human CSps
Other Intervention Name(s)
Biological: Allogeneic Human CSps (or alloCSps)
Intervention Description
NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.
Intervention Type
Biological
Intervention Name(s)
Endomyocardial injections of vehicle only.
Intervention Description
NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Marban, MD, PhD
Organizational Affiliation
Cedars-Sinai Medical Center, Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Learn more about this trial

REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts

We'll reach out to this number within 24 hrs